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AstraZeneca to collaborate with Inserm in type 2 diabetes and Chronic Kidney Disease studies

Pressmeddelanden   •   2015-06-17 08:02 CEST

AstraZeneca today announced a three-year research collaboration with the French National Institute of Health and Medical Research (Inserm) to investigate new therapeutic approaches to type 2 diabetes and Chronic Kidney Disease (CKD). The aim of the collaboration is to advance understanding of the biological mechanisms that underpin these conditions and develop new treatments based on this knowledge.

Under the terms of the collaboration, each project will comprise a joint team of investigators that will work across Inserm sites in Toulouse and Paris, and AstraZeneca’s research hub in Mölndal, Sweden. The collaboration will focus on three areas:

Understanding mineralocorticoid receptor (MR) activity as a route to treating CKD

Excessive MR activation is an important mechanism in the development of CKD; however, this receptor also plays a crucial role in maintaining the body’s electrolyte balance. AstraZeneca together with a team led by Professor Frederic Jaisser at the Cordeliers Research Centre (Inserm unit 1138) in Paris, will aim to better understand the complexities of MR activity as a potential treatment for CKD.

Enhancing tissue sensitivity to insulin

In healthy people, fat cells store lipids when the person is fed (state of energy excess) and release them in the fasting state. However, in obese and insulin-resistant patients, excess fat tissue leads to an uncontrolled release of lipids into the bloodstream. This leads to fat accumulation in tissues such as the liver and in muscle, triggering resistance to the action of insulin in those tissues and predisposing to type 2 diabetes. AstraZeneca together with a team led by Professor Dominique Langin at the Inserm/Paul Sabatier University Institute of Metabolic and Cardiovascular Disease (I2MC, Inserm unit 1048) in Toulouse will explore pharmacological ways to prevent the release of lipids into the circulation, normalise fat deposition and increase insulin sensitivity in peripheral tissues.

Exploring loss of insulin production

Beta cells are a type of cell found in the pancreas which produce and release insulin. In type 2 diabetes, both the quantity of beta cells and their ability to produce and secrete insulin are decreased. AstraZeneca together with a team led by Dr Raphaël Scharfmann at the Inserm/University Paris-Descartes unit 1016 "Cochin Institute" in Paris, will develop models of human beta cells which have lost their ability to produce and release insulin to better understand the biology of this effect and how it cn be corrected through treatment.

Marcus Schindler, Head of Cardiovascular and Metabolic Diseases Innovative Medicines unit, AstraZeneca said: “Over the last few years AstraZeneca has been focusing on pioneering research into cardiovascular and metabolic disease. By joining forces with Professors Langin, Jaisser and Scharfmann and their eminent research groups at Inserm, we strengthen further this ambition because their focus represents an ideal fit with our research strategy.”

Professor Christian Boitard, Director of the Inserm institute for Physiopathology, Metabolism and Nutrition, said: “This collaboration is focusing our efforts in beta cells, mineralocorticoid receptor and lipids handling by tissues. Combining the AstraZeneca and Inserm scientists, expertise and platforms represents a great opportunity for advancing research in these important fields, with the operational support of Inserm Transfert teams.”

-ENDS-

NOTES TO EDITORS

About Inserm

Founded in 1964, the French National Institute of Health and Medical research (Inserm) is a public science and technology institute, jointly supervised by the French Ministry of National Education, Higher Education and Research and the Ministry of Social Affairs, Health and women's Rights. Inserm is the only French public research institute to focus entirely on human health with nearly 15000 researchers, engineers, technicians, post-doctoral students and more than 300 laboratories. The mission of its scientists is to study all diseases, from the most common to the rarest. Inserm is a member of Aviesan*, the French National Alliance for Life Sciences and Health founded in 2009.
* Other founding members of Aviesan : CEA, CNRS, CHRU, CPU, INRA, INRIA, Inserm, Institut Pasteur, IRDInserm Transfert, its private subsidiary, has full responsibility for all technology transfer activities of Inserm. www.inserm.fr

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

CONTACTS

Media Enquiries

Karen Birmingham+44 20 7604 8120 (UK/Global)

Esra Erkal-Paler+44 20 7604 8030 (UK/Global)

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

​AstraZeneca today announced a three-year research collaboration with the French National Institute of Health and Medical Research (Inserm) to investigate new therapeutic approaches to type 2 diabetes and Chronic Kidney Disease (CKD).

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AstraZeneca to collaborate with the University of Michigan to advance treatments for chronic kidney disease

Pressmeddelanden   •   2015-06-17 08:02 CEST

AstraZeneca today announced a two-year research collaboration with the University of Michigan to advance the treatment of chronic kidney disease (CKD) through the improved understanding of the disease. The collaboration will tackle the challenging area of identifying novel targets for the treatment of CKD, focusing on the use of patient tissue and validation of preclinical models.

CKD is a condition in which the kidneys are damaged and cannot filter blood effectively, leading to waste from the blood remaining in the body, which may cause other health problems such as cardiovascular disease, heart attack or stroke. Most patients progress eventually to end-stage renal disease and require haemodialysis and kidney transplantation.

Under the terms of the collaboration, scientists from AstraZeneca’s laboratories in Mölndal, Sweden, will work with a team of investigators at the University of Michigan led by Matthias Kretzler, Professor of Internal Medicine and Computational Medicine and Bioinformatics to:

  • examine databases of biopsies from CKD patients to identify biological targets and pathways which predict disease progression
  • create improved animal models that better reflect the human disease condition
  • identify biomarkers in patient samples which are associated with disease progression and response to treatment

Marcus Schindler, Head of the Cardiovascular and Metabolic Diseases (CVMD) Innovative Medicines Unit, AstraZeneca, said: “Current approaches to treating the complications of diabetes mean that patients need expensive treatment options which are often limited, so there is a significant unmet medical need. Through this collaboration, we will generate increasing evidence that we are pursuing the right therapeutic targets to treat CKD which will shift clinical therapy to a more focused patient population, giving a better response to treatments and slowing disease progression.”

Matthias Kretzler said: “The collaboration builds on the promise of combining basic university research, which can uncover specific targets for precise-acting drugs, with drug compound development by AstraZeneca.Steered by science, we will examine new approaches to treating the damage that diabetes inflicts on the kidneys of millions of people.”

– ENDS –

NOTES TO EDITORS

About the University of Michigan

The University of Michigan Health System creates the future of health care through medical education, patient care and research. UMHS is a community of more than 26,000 faculty, staff, trainees and volunteers, including 3 hospitals and 40 outpatient locations. The University of Michigan Medical School consistently ranks among the top research universities in the United States and world. With one of the nation's largest research budgets, The University of Michigan finds new ways to understand, diagnose, treat, manage and prevent many human diseases.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

 

CONTACTS

Media Enquiries

Karen Birmingham+44 20 7604 8120 (UK/Global)

Esra Erkal-Paler+44 20 7604 8030 (UK/Global)

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

AstraZeneca today announced a two-year research collaboration with the University of Michigan to advance the treatment of chronic kidney disease (CKD) through the improved understanding of the disease.

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AstraZeneca appoints Pam Cheng as Executive Vice President, Operations and IT

Pressmeddelanden   •   2015-06-16 08:02 CEST

AstraZeneca today announced that Pam P. Cheng has joined the Company as Executive Vice President, Operations and IT. Pam will succeed David Smith, who is retiring after nearly ten years with AstraZeneca.

Pam will be responsible for manufacturing operations and supply chain, procurement and information technology globally. In the role she will oversee continued progress in driving efficiency and delivering excellence in these areas.

Pam joins AstraZeneca from Merck/MSD, where she gained extensive experience in pharmaceuticals manufacturing and supply chain management. She played a lead role in restructuring and upgrading the company’s manufacturing technology and engineering capabilities as Director of Global Planning and Capacity Management, and as Head of Global Supply Chain Management and Logistics led the transformation of the company’s supply chains across its global network. Most recently, Pam was Chief Operating Officer and then President of MSD China. Prior to joining Merck, Pam held Process Engineering roles at Union Carbide and GAF Chemicals.

Pascal Soriot, Chief Executive Officer, said: “I am delighted to welcome Pam to AstraZeneca at a very exciting time for our business. As our pipeline delivers, we will bring an increasing number of new medicines to patients across the globe over the coming years, including important biological therapies as our product mix shifts. Pam will be able to bring to bear her wealth of experience in manufacturing and supply chain management, as well as her experience in emerging markets, particularly China, a key priority for our company.”

“I also want to take the opportunity to thank David Smith for the invaluable contribution he has made to the leadership of AstraZeneca and to streamlining and expanding our global manufacturing footprint. The quality, reliability and cost effectiveness of our supply chain will be his legacy for many years to come.”

Pam will report to Pascal Soriot and will be a member of AstraZeneca’s Senior Executive Team.

Pam holds bachelor’s and master’s degrees in Chemical Engineering from Stevens Institute of Technology in New Jersey and an MBA in Marketing from Pace University in New York.

– ENDS –

NOTES TO EDITORS

To obtain a photograph of Pam Cheng please visit www.astrazeneca.com/media/photo-library or contact the media team (details below).

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

CONTACTS

Media Enquiries

Esra   Erkal-Paler+44 20 7604 8030   (UK/Global)
Vanessa   Rhodes+44 20   7604 8037 (UK/Global)
Ayesha   Bharmal+44 20   7604 8034 (UK/Global)
Jacob   Lund +46   8 553 260 20 (Sweden)
Michele   Meixell+ 1 302   885 6351 (US)

Investor Enquiries

Thomas   Kudsk Larsen+44 20   7604 8199mob: +44   7818 524185
Eugenia   LitzRespiratory, Inflammation and Autoimmunity+44 20   7604 8233mob: +44   7884 735627
Nick StoneCardiovascular and   Metabolic Disease+44 17 6326 3994mob: +44 7717 618834
Karl HårdOncology+44 20   7604 8123mob: +44   7789 654364
Craig   MarksInfection, Neuroscience and Gastrointestinal Disease+44 20   7604 8591mob: +44   7881 615764
Christer Gruvris+44 20 7604 8126mob: +44 7827 836825

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

AstraZeneca today announced that Pam P. Cheng has joined the Company as Executive Vice President, Operations and IT.

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Tillverkar nedbrytbar plast och renar vatten på sommarlovet

Pressmeddelanden   •   2015-06-15 08:00 CEST

AstraZenecas Sommarforskarskola med spetsplatser för 14 - 17 åringar som vill ha extra utmaningar

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New real-world data analysis finds no evidence of increased risk of hospitalisation for heart failure with saxagliptin compared with sitagliptin

Pressmeddelanden   •   2015-06-08 13:04 CEST

Study also found no evidence of increased risk of hospitalisation for heart failure for DPP-4 inhibitors compared with sulfonylureas

AstraZeneca today announced results from an observational, retrospective study which found no evidence of increased risk of hospitalisation for heart failure (hHF) with saxagliptin, compared with sitagliptin, both of which are dipeptidyl peptidase-4 (DPP-4) inhibitors, in patients with type 2 diabetes.A similar finding was obtained when comparing the overall DPP-4 class to sulfonylureas. The analysis included patients with and without prior cardiovascular disease (CVD), and among those patients without prior cardiovascular disease (CVD), DPP-4 treatment was associated with statistically significant lower risk for hHF compared to treatment with sulfonylureas.

The data were presented during a late-breaker poster session at the 75th Scientific Sessions of the American Diabetes Association (ADA) in Boston, 5-9 June 2015.

“These new data provide valuable real-world information regarding the cardiovascular safety of the DPP-4 inhibitor class in patients with type 2 diabetes,” said Alex Fu, PhD, Principal Investigator for this study and Associate Professor, Georgetown University Medical Center, Washington, D.C. “In particular, the study findings provide new information on the risk of hospitalisation for heart failure for DPP-4 inhibitors, and specifically for saxagliptin relative to sitagliptin, within this class.”

The real-world evidence study used a retrospective, observational, new-user cohort design comprised of US inpatient medical, outpatient medical, and outpatient pharmacy insurance claims data for patients with type 2 diabetes from August 2010 to August 2013. Both commercial and Medicare databases were part of the analysis.Analyses of the claims were stratified by the presence or absence of baseline CVD, which was defined as patients having at least one medical claim with any CVD code, and those without CVD. Patients in the comparator groups were matched for demographic, clinical and hHF risk factors using propensity score matching.

For the comparison of saxagliptin versus sitagliptin for the risk of hHF, more than 100,000 patients were included. For patients with baseline CVD, the hazard ratio (HR) was 0.95: 95% confidence interval (CI): 0.70, 1.28. For patients with no baseline CVD, the HR was 0.99: 95% CI: 0.56, 1.75.

For the comparison of DPP-4 inhibitors versus sulfonylureas, more than 200,000 patients were included. For patients with CVD at baseline, the HR was 0.95: 95% CI: 0.78, 1.15. For patients with no baseline CVD, the HR was 0.59: 95% CI: 0.38, 0.89.

Secondary outcomes of this retrospective, observational analysis, including hospitalisation for acute myocardial infarction, stroke, unstable angina; coronary revascularisation; and a composite of all outcomes together, including hHF, were consistent with the primary findings of this study. While the study observations provide important information, all retrospective claims database studies have inherent limitations that include the potential for bias due to their retrospective non-randomised design and the potential for incomplete or inaccurate claims data.

The SAVOR study

The real-world evidence analysis follows the findings of the SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) study, published in October 2013 in the New England Journal of Medicine. The study was a large, randomised, double-blind, placebo-controlled Phase IV clinical trial in patients with type 2 diabetes at high risk of CVD, designed and conducted in accordance with the 2008 FDA guidance, “Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.” Patients who participated in SAVOR had either a history of established CVD or multiple risk factors for vascular disease, including renal impairment. The primary objective of this trial was to determine that the addition of saxagliptin to standard of care in this patient population did not significantly increase the incidence of major cardiovascular events as compared with placebo.

SAVOR met the primary safety objective, demonstrating that saxagliptin did not increase the risk for cardiovascular death, nonfatal myocardial infarction (MI), and nonfatal ischaemic stroke when added to a patient’s current standard of care (with or without other antidiabetic therapies), as compared with placebo (613 patients [3.7 per 100 person-years] in the saxagliptin group compared with 609 patients [3.7 per 100 person-years] in the placebo group ( HR: 1.00; [95% CI: 0.89, 1.12]; non-inferiority p-value < 0.001; superiority p-value = 0.99).

For the secondary endpoint of nonfatal MI, nonfatal stroke, cardiovascular death, hospitalisation for heart failure, hospitalisation for unstable angina, or hospitalisation for coronary revascularisation, notreatment differences were observed between saxagliptin and placebo (HR 1.02 [95% CI 0.94, 1.11]; nominal p=0.66 for a difference between the two treatment groups). However, an increased risk for hHF, a component of the balanced secondary endpoint, was observed with saxagliptin treatment. The analysis showed a numerical imbalance with more events on saxagliptin [289 (3.5% and 228 (2.8%) (HR 1.27 [95% CI 1.07, 1.51]; nominal p=0.007), although a causal relationship has not been established. Caution is warranted if saxagliptin is used in patients who have known risk factors for hospitalisation for heart failure, such as a history of heart failure or moderate to severe renal impairment.

AstraZeneca is committed to patient safety and continues to work with regulatory agencies to ensure further the SAVOR findings are appropriately communicated in prescribing information.

-ENDS-

NOTES TO EDITORS

About ONGLYZA (saxagliptin)

As of March 2015, ONGLYZA is approved in more than 90 countries, including those in the European Union, the United States, Canada, Mexico, India, Brazil and China. ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. ONGLYZA should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ONGLYZA has not been studied in patients with a history of pancreatitis.

About Komboglyze (saxagliptin + metformin HCI)

Komboglyze is formulated with metformin and therefore is contraindicated in patients with moderate or severe renal impairment (creatinine clearance <60 mL/min), diabetic ketoacidosis, hepatic impairment, or acute or chronic disease that may cause tissue hypoxia, such as cardiac or respiratory failure, recent MI, or shock.

About DPP-4 Inhibitors

Saxagliptin belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. Incretin hormones decrease elevated blood sugar levels (glucose) by increasing the body’s utilization of sugar, mainly through increasing insulin production in the pancreas, and by reducing the liver’s production of glucose. DPP-4 inhibitors work by increasing the activity of the incretin hormones, increasing the release of insulin when glucose levels are elevated and reducing the levels of sugar produced by the liver.

About Type 2 Diabetes

Diabetes is estimated to affect 29.1 million people in the US and more than 382 million people worldwide. The prevalence of diabetes is projected to reach more than 592 million people worldwide by 2035. Type 2 diabetes accounts for approximately 90-95 percent of all cases of diagnosed diabetes in the US. Type 2 diabetes is a chronic disease characterised by pathophysiologic defects leading to elevated glucose levels. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen. It is estimated that more than half of people living with type 2 diabetes are not achieving recommended HbA1c goals based on guidelines established by professional societies and advocacy organisations for diabetes management.

About AstraZeneca in Diabetes

AstraZeneca is pushing the boundaries of science to create life-changing medicines that aim to reduce the global burden and complications of diabetes. Driven to redefine outcomes for diabetes patients, our current portfolio consists of the three newest classes of non-insulin, anti-diabetic treatments that support individualised treatment approaches: SGLT-2 inhibitors, GLP-1 receptor agonists and DPP-4 inhibitors. Our commitment to diabetes is exemplified by the depth and breadth of our global clinical research programme. This commitment is advancing understanding of the treatment effects of our diabetes medicines in broad patient populations, as well as exploring combination treatment approaches resulting in more patients achieving treatment success earlier in their disease progression. Our ambition is to reduce the long-term impact of diabetes. As a core strategic area for the company, we are focusing our research and development efforts in diverse populations and patients with significant co-morbidities, such as cardiovascular disease, heart failure, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

CONTACTS

Media Enquiries

Esra Erkal-Paler +44 20 7604 8030 (UK/Global)

Vanessa Rhodes +44 20 7604 8037 (UK/Global)

Ayesha Bharmal +44 20 7604 8034 (UK/Global)

Jacob Lund +46 8 553 260 20 (Sweden)

Michele Meixell +1 302 885 6351 (US)

Investor Enquiries

UK
Thomas Kudsk Larsen+44 20 7604 8199mob: +44 7818 524185
Eugenia LitzRespiratory, Inflammation and Autoimmunity+44 20 7604 8233mob: +44 7884 735627
Nick StoneCardiovascular and Metabolic Disease+44 17 6326 3994mob: +44 7717 618834
Karl HårdOncology+44 20 7604 8123mob: +44 7789 654364
Craig MarksInfection, Neuroscience and Gastrointestinal Disease+44 20 7604 8591mob: +44 7881 615764
Christer   Gruvris+44   20 7604 8126mob:   +44 7827 836825
US
Dial / Toll-Free+1 301 398 3251+1 866 381 7277

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

Study also found no evidence of increased risk of hospitalisation for heart failure for DPP-4 inhibitors compared with sulfonylureas

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AstraZeneca presents new positive phase III data on triple therapy approach with dapagliflozin, saxagliptin and metformin for type 2 diabetes

Pressmeddelanden   •   2015-06-06 20:17 CEST

Data in oral presentation demonstrate that the investigational combination of dapagliflozin, saxagliptin and metformin resulted in statistically significant reductions in HbA1c in patients uncontrolled on saxagliptin and metformin

AstraZeneca today announced positive results from a Phase III study comparing the efficacy and safety of dapagliflozin versus placebo as an add-on to saxagliptin and metformin immediate release (IR) in adults with type 2 diabetes who had inadequate glycaemic control (baseline HbA1c 7% - 10.5%).1 The study met its primary endpoint, with patients receiving the investigational triple combination of dapagliflozin 10 mg, saxagliptin 5 mg and metformin achieving significantly greater mean reductions in HbA1c compared to those treated with placebo, saxagliptin 5 mg and metformin at 24 weeks (–0.82% vs. -0.10%, respectively; p-value<0.0001).1 The results were presented today as an oral presentation (#105-OR) at the 75th Scientific Sessions of the American Diabetes Association (ADA) in Boston.

“In this study, when dapagliflozin was added to saxagliptin and metformin, patients demonstrated greater HbA1C reductions than those in the placebo and metformin group,” said lead investigator Chantal Mathieu, MD, PhD, Chair of Endocrinology at the University Hospital Gasthuisberg Leuven, Belgium. “With nearly 50% of type 2 diabetes patients estimated to be uncontrolled on metformin, new treatment approaches are needed, and these data add to the growing body of knowledge for combination therapies.”

Among secondary endpoints, the dapagliflozin combination group achieved a significantly greater adjusted mean reduction from baseline in two-hour postprandial glucose (-74 mg/dL vs -38 mg/dL, respectively; p-value<0.0001)1 and fasting plasma glucose versus the placebo group (-33 mg/dL vs -5 mg/dL, respectively; p-value<0.0001).1 More patients in the dapagliflozin combination group also achieved a HbA1c level of less than 7% compared to patients in the placebo group at week 24 (38% vs 12%, respectively, p-value<0.0001).1 In addition, patients in the dapagliflozin combination group had a greater reduction in weight (mean -1.9 kg vs -0.4 kg, respectively; p-value<0.0001)1 than those in the placebo group. Adverse events were similar across treatment groups. The most common adverse events (≥ 5%) were headache, urinary tract infection, influenza and genital infections. The rate of hypoglycaemia was 1.3% in the dapagliflozin combination group and 0.0% in the placebo group.1

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, AstraZeneca, said: “We are focused on investigating combination therapies with complementary mechanisms of action and our broad diabetes portfolio positions us well in this area.These positive results reinforce our belief that combination therapies have the potential to be used as early add-on therapy to help patients with type 2 diabetes achieve their treatment goals.”

The study included an open-label lead-in period in which patients on metformin (baseline HbA1c 8.0%–11.5%) received open-label saxagliptin 5 mg and metformin for 16 weeks, while patients on metformin and any DPP-4 inhibitor (baseline HbA1c 7.5%–10.5%) received open-label saxagliptin 5 mg and metformin for 8 weeks. Following the end of the open-label period, patients with inadequate glycaemic control (HbA1c 7%–10.5%) were randomised to receive either placebo or dapagliflozin 10 mg in addition to open-label saxagliptin and metformin.

Data further detailing this lead-in period was accepted as a late-breaker poster (#133-LB) on display in Poster Hall B on Sunday, June 7 from noon to 2 p.m. EST.2

AstraZeneca has filed a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for the approval of an investigational fixed-dose combination of saxagliptin and dapagliflozin for the treatment of type 2 diabetes and the Prescription Drug User Fee Act (PDUFA) goal date will be in the fourth quarter of 2015.

NOTES TO EDITORS

About the Study

This 24-week, Phase III, randomised, double-blind study of 320 adult patients (aged ≥ 18 years) with type 2 diabetes was designed to compare the efficacy and safety of dapagliflozin versus placebo as an add-on to dual treatment of saxagliptin and metformin in adult patients with type 2 diabetes who were uncontrolled on saxagliptin and metformin. The primary endpoint was change in HbA1c from baseline at week 24. Secondary endpoints included fasting plasma glucose, two-hour postprandial glucose, body weight and the proportion of patients achieving A1c<7%.1

About DPP-4 inhibitors and SGLT2 inhibitors

Saxagliptin (marketed as Onglyza®) belongs to the class of medicines called DPP-4 inhibitors, which work by increasing the activity of the incretin hormones, increasing the release of insulin when glucose levels are elevated and reducing the levels of sugar produced by the liver (glucagon). Dapagliflozin (marketed as Farxiga® in the US and Forxiga® outside the US) is part of a newer class of medicines called sodium-glucose cotransporter 2 (SGLT2) inhibitors, which remove glucose via the kidneys.

About Type 2 Diabetes

Diabetes is estimated to affect 29.1 million people in the US and more than 387 million people worldwide. The prevalence of diabetes is projected to reach more than 592 million people worldwide by 2035. Type 2 diabetes accounts for approximately 90-95 percent of all cases of diagnosed diabetes in the US. Type 2 diabetes is a chronic diseasecharacterised by pathophysiologic defects leading to elevated glucose levels. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen. It is estimated that more than half of people living with type 2 diabetes are not achieving recommended HbA1c goals based on guidelines established by professional societies and advocacy organisations for diabetes management.

About AstraZeneca in Diabetes

AstraZeneca is pushing the boundaries of science to create life-changing medicines that aim to reduce the global burden and complications of diabetes. Driven to redefine outcomes for diabetes patients, our current portfolio consists of the three newest classes of non-insulin, anti-diabetic treatments that support individualised treatment approaches: SGLT-2 inhibitors, GLP-1 receptor agonists and DPP-4 inhibitors. Our commitment to diabetes is exemplified by the depth and breadth of our global clinical research programme. This commitment is advancing understanding of the treatment effects of our diabetes medicines in broad patient populations, as well as exploring combination treatment approaches resulting in more patients achieving treatment success earlier in their disease progression. Our ambition is to reduce the long-term impact of diabetes. As a core strategic area for the company, we are focusing our research and development efforts indiverse populations and patients with significant co-morbidities, such as cardiovascular disease, heart failure, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

– ENDS –

CONTACTS

Media Enquiries

Esra Erkal-Paler +44 20 7604 8030 (UK/Global)

Vanessa Rhodes +44 20 7604 8037 (UK/Global)

Ayesha Bharmal +44 20 7604 8034 (UK/Global)

Jacob Lund +46 8 553 260 20 (Sweden)

Michele Meixell +1 302 885 6351 (US)

Investor Enquiries

UK
Thomas Kudsk   Larsen+44 20 7604   8199mob: +44 7818   524185
Eugenia LitzRespiratory,   Inflammation and Autoimmunity+44 20 7604   8233mob: +44 7884   735627
Nick StoneCardiovascular and Metabolic   Disease+44 17 6326   3994mob: +44 7717 618834
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Craig MarksInfection,   Neuroscience and Gastrointestinal Disease+44 20 7604   8591mob: +44 7881   615764
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US
Dial   / Toll-Free+1 301 398 3251+1 866 381 7277

_______________

1Mathieu, C., et al. “A Randomized Double-Blind Phase 3 Trial of Dapagliflozin Add-On to Saxagliptin + Metformin in Type 2 Diabetes.” American Diabetes Association Scientific Sessions 2015. Abstract #105-OR.

2Mathieu, C., et al. “Triple Therapy with Dapagliflozin Add-on to Saxagliptin Plus Metformin: Characterization of the Open-Label Saxagliptin + Metformin Lead-in Period of a Phase 3 Trial.” American Diabetes Association Scientific Sessions 2015. Abstract #133-LB.

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

Data in oral presentation demonstrate that the investigational combination of dapagliflozin, saxagliptin and metformin resulted in statistically significant reductions in HbA1c in patients uncontrolled on saxagliptin and metformin

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AstraZeneca to present data demonstrating progress of its comprehensive diabetes portfolio at the American Diabetes Association 75th scientific sessions

Pressmeddelanden   •   2015-06-03 08:03 CEST

  • 86 abstracts represent significant investment in diabetes research with a focus on individualised treatment approaches
  • Notable late-breaker abstracts include data from a Phase III study comparing the efficacy and safety of dapagliflozin versus placebo as an add-on to saxagliptin and metformin in adults with type 2 diabetes
  • New real-world data from an observational, retrospective claims database study comparing the risk of hospitalisation for heart failure between DPP-4 inhibitors vs. sulfonylureas and comparing saxagliptin with sitagliptin
  • Data to advance understanding of the efficacy and safety of AstraZeneca’s comprehensive diabetes portfolio and the multiple diabetes-related cardiovascular risk factors

AstraZeneca today announced that 86 abstracts reporting results of the company’s research and development in diabetes have been accepted for presentationat the 75th Scientific Sessions of the American Diabetes Association (ADA) in Boston, 5-9 June 2015.

The abstracts include clinical data evaluating Forxiga® (dapagliflozin, marketed in the U.S. as Farxiga®), Bydureon® (exenatide extended-release for injectable suspension), Byetta® (exenatide) injection and Onglyza® (saxagliptin), as well as the investigational combination of saxagliptin and dapagliflozin. Among the abstracts accepted are studies evaluating long-term durability; safety and efficacy; medication adherence; and benefits and treatment effects across diverse subpopulations segmented by ethnicity and risk factors such as kidney disease and cardiovascular (CV) disease. Notable late-breaker abstracts include data from a Phase III study comparing the efficacy and safety of dapagliflozin versus placebo as an add-on to saxagliptin and metformin in adults with type 2 diabetes who had inadequate glycaemic control, including an overview of the open-label lead-in period.

“The extensive scientific data at ADA underscore our research goals to better understand the long-term effects of newer classes of medicines across different patient populations,” said Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, AstraZeneca. “These data further demonstrate the value of our current portfolio to help address the needs of a broad range of patients with type 2 diabetes.”

In addition to advancing clinical and scientific discussions, AstraZeneca is also presenting a number of observational and medical outcomes studies, including new real-world data from an observational, retrospective claims database study comparing the risk of hospitalisation for heart failure between DPP-4 inhibitors vs. sulfonylureas and comparing saxagliptin with sitagliptin. [1]

Notable clinical and pre-clinical data being presented across key focus areas for AstraZeneca include:

Investigational new data

  • Study      of baseline albuminuria level versus the efficacy of dapagliflozin in      patients with type 2 diabetes (#108-OR, Saturday 6 June, 1:45 p.m. EDT)[2]

  • Assessment of dapagliflozin effects on albuminuria reductions      in hypertensive patients with diabetes (#1176-P, Saturday 6 June, 12:30      p.m. EDT)[3]
  • Pharmacodynamic comparison of dapagliflozin in patients with type      1 or type 2 diabetes (#1174-P, Saturday 6 June, 12:30 p.m. EDT)[4]
  • An analysis of dapagliflozin on insulin resistance in type 2 diabetes      (#1179-P, Saturday 6 June, noon EDT)[5]
  • Pre-clinical analysis of the effects of a GLP-1 receptor agonist/glucagon co-agonist (MEDI0382) on weight (#2119–P, Sunday 7 June, noon EDT)[6]

Data assessing combination treatments and treatment approaches in select subgroups of patients

  • An analysis of triple therapy with dapagliflozin versus placebo when added-on to saxagliptin plus metformin, including an overview of the open-label lead-in period (#133–LB, Sunday 7 June, noon EDT)[7]
  • Study      determining influential factors affecting preferences for the treatment of      diabetes (#206–OR, Sunday 7 June, 2:15 p.m. EDT)[8]
  • A study examining the addition of saxagliptin, compared to placebo,treatment with dapagliflozin and metformin in patients with type 2 diabetes with inadequate glycaemic control (#104-OR, Saturday 6 June, 1:45 p.m. EDT)[9]

  • A study examining the addition of dapagliflozin, compared to placebo, to treatment with saxagliptin and metformin in patients with type 2 diabetes with inadequate glycaemic control (#105-OR, Saturday 6 June, 1:45 p.m. EDT)[10]

  • Retrospective study of once-weekly exenatide treatment and adherence in elderly patients compared to other GLP-1 receptor agonists (#1144–P, Saturday 6 June, 11:30 a.m. EDT)[11]
  • Comparison of one-year adherence, costs and utilisation between insured patients with type 2 diabetes initiating liraglutide or once-weekly exenatide (#1125-P, Saturday 6 June 11:30 a.m. EDT)[12]
  • Dapagliflozin as a treatment option for African Americans and Hispanic Adult patients with type 2 diabetes (#1217–P, Sunday 7 June, noon EDT)[13]
  • Saxagliptin as a treatment option for Caucasian, African Americans, Asian, and Hispanic patients with type 2 diabetes (#1248–P, Sunday 7 June, noon EDT)[14]
  • Pre-clinical assessment of interactions of low dose combinations of GLP-1 receptor and GIP on glucose control in mice (#2350–P, Sunday 7 June, noon EDT)[15]

Data assessing the long-term effect and durability of AstraZeneca diabetes treatments

  • Effect on dapagliflozin on weight over the first year of treatment through the subsequent three years (#103–OR, Saturday 6 June, 2:15 p.m. EDT)[16]
  • Study of long-term effects of once-weekly exenatide on weight gain and hypoglycaemia, compared to insulin glargine. (#1120–P, Saturday 6 June, 11:30 a.m. EDT)[17]
  • Effects of exenatide twice daily and once weekly on A1C in patients with type 2 diabetes and baseline A1C ≥10%. (#1126–P, Saturday 6 June, 11:30 a.m. EDT)[18]
  • Analysis of the use of saxagliptin and cancer risk in the SAVOR trial (#11–OR, Friday 5 June, 4:15 p.m. EDT)[19]

Data assessing diabetes treatments and cardiovascular outcomes in patients at high CV risk

  • Analysis of dapagliflozin on CV events in elderly patients with type 2 diabetes (#15–OR, Friday 5 June, 4:45 p.m. EDT)[20]
  • SAVOR analysis on rates of CV risk and polyvascular disease in patients with type 2 diabetes (#56–OR, Saturday 6 June, 8:15 a.m. EDT)[21]
  • Analysis of long-term efficacy of dapagliflozin treatment on patients with CV disease and type 2 diabetes (#106–OR, Saturday 6 June, 3:00 p.m. EDT)[22]
  • Results of the SAVOR trial analysing CV outcomes in African Americans receiving treatment with saxagliptin (#15-LB; Sunday 7 June, noon EDT)[23]
  • Observational analysis comparison of the risk of hospitalization for heart failure between DPP-4 inhibitors vs. sulfonylureas and with saxagliptin vs. sitagliptin

(#164–P, Sunday 7 June, noon EDT)1

The complete list of AstraZeneca data presentations can be accessed on the ADA website here.

– ENDS –

NOTES TO EDITORS

About Type 2 Diabetes

Diabetes is estimated to affect 29.1 million people in the US and more than 387 million people worldwide. The prevalence of diabetes is projected to reach more than 592 million people worldwide by 2035. Type 2 diabetes accounts for approximately 90-95 percent of all cases of diagnosed diabetes in the US. Type 2 diabetes is a chronic disease characterised by pathophysiologic defects leading to elevated glucose levels. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen. It is estimated that more than half of people living with type 2 diabetes are not achieving recommended HbA1c goals based on guidelines established by professional societies and advocacy organisations for diabetes management.

About AstraZeneca in Diabetes

AstraZeneca is pushing the boundaries of science to create life-changing medicines that aim to reduce the global burden and complications of diabetes. Driven to redefine outcomes for diabetes patients, our current portfolio consists of the three newest classes of non-insulin, anti-diabetic treatments that support individualised treatment approaches: SGLT-2 inhibitors, GLP-1 receptor agonists and DPP-4 inhibitors. Our commitment to diabetes is exemplified by the depth and breadth of our global clinical research programme. This commitment is advancing understanding of the treatment effects of our diabetes medicines in broad patient populations, as well as exploring combination treatment approaches resulting in more patients achieving treatment success earlier in their disease progression. Our ambition is to reduce the long-term impact of diabetes. As a core strategic area for the company, we are focusing our research and development efforts indiverse populations and patients with significant co-morbidities, such as cardiovascular disease, heart failure, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

CONTACTS

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Michele Meixell +1 302 885 6351 (US)

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Thomas Kudsk   Larsen+44 20 7604   8199mob: +44 7818   524185
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Nick StoneCardiovascular and Metabolic   Disease+44 17 6326   3994mob: +44 7717 618834
Karl HårdOncology+44 20 7604   8123mob: +44 7789   654364
Craig MarksInfection,   Neuroscience and Gastrointestinal Disease+44 20 7604   8591mob: +44 7881   615764
Christer Gruvris+44 20 7604 8126mob: +44 7827 836825
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[1] Fu, A., et al. “Observational Study Comparing the Risk of Hospitalization for Heart Failure between Dipeptidyl Peptidase inhibtors vs. Sulfonlyureas and Saxaglitpin vs Sitagliptin.” American Diabetes Association Scientific Sessions 2015. Abstract #164-LB

[2] Parikh, S., et al. “Dapagliflozin Efficacy is Unaffected by Baseline Albuminuria Level in Patients with Type 2 Diabetes.” American Diabetes Association Scientific Sessions 2015. Abstract #108-OR

[3] Lambers-Heerspink. H., et al., “Dapagliflozin Reduces Albuminuria On Top of Renin-Angiotensin System Blockade in Hypertensive Diabetic Patients.” American Diabetes Association Scientific Sessions 2015. Abstract #1176-P

[4] Tang, W., et al. “Comparison of Pharmacodynamics of Dapagliflozin in Patients With Type 1 or Type 2 Diabetes Mellitus.” American Diabetes Association Scientific Sessions 2015. Abstract #1174-P

[5] Katz, A., et al. “Dapagliflozin and Insulin Resistance in Patients With Type 2 Diabetes.” American Diabetes Association Scientific Sessions 2015. Abstract #1179-P

[6] Agoram, B., et al. “Robust Anti-Obesity and Metabolic Effects of GLP-1/Glucagon Co-Agonist Peptide in Rodents and Non-Human Primates.” American Diabetes Association Scientific Sessions 2015. Abstract #2119

[7] Mathieu, C., et al. “Triple Therapy With Dapagliflozin (DAPA) Add-on to Saxagliptin (SAXA) Plus Metformin (MET): Characterization of the Open-Label SAXA+MET Lead-in Period of a Phase 3 Trial.” American Diabetes Association Scientific Sessions 2015. Abstract #133-LB

[8] Bell, K., et al. “Most influential factors determining patient preferences for diabetes treatment.” American Diabetes Association Scientific Sessions 2015. Abstract #206-OR

[9] Matthaei, S., et al. “A Randomized, Double-Blind Trial of Saxagliptin Add-on to Dapagliflozin + Metformin.” American Diabetes Association Scientific Sessions 2015. Abstract #104-OR

[10] Mathieu, C., et al. “A Randomized, Double-Blind, Phase 3 Trial of Dapagliflozin Add-on to Saxagliptin + Metformin in Type 2 Diabetes.” American Diabetes Association Scientific Sessions 2015. Abstract #105-OR

[11] Dufour, R., et al. “Real-World Adherence in Patients Aged ≥ 65 years With Type 2 Diabetes Mellitus for Exenatide QW, Liraglutide QD and Exenatide BID.” American Diabetes Association Scientific Sessions 2015. Abstract #1144-P

[12]Johnston, S., et al. “Comparison of 12-month Adherence and Healthcare Costs and Utilization Between Commercially-insured Patients with Type 2 Diabetes Mellitus Newly-initiating Liraglutide Once Daily or Exenatide Once Weekly in Real-World U.S. Clinical Practice.” American Diabetes Association Scientific Sessions 2015. Abstract #1125-P

[13] Moran, J., et al. “Efficacy and Safety of Dapagliflozin in Patients With Type 2 Diabetes: Outcomes by Race and Ethnicity.” American Diabetes Association Scientific Sessions 2015. Abstract #1217-P

[14] Barrett, Y., et al. “Efficacy and Safety of Saxagliptin in Patients With Type 2 Diabetes: Outcomes by Race and Ethnicity.” American Diabetes Association Scientific Sessions 2015. Abstract #1248-P

[15] Suckow, AT., et al. “Anti-obesity and anti-diabetic activity of combinations of GIP and GLP-1 Fc-fusion proteins in obese and diabetic mice.” American Diabetes Association Scientific Sessions 2015. Abstract 2350-P.

[16] Stenlof, K., et al. “Maintenance of Weight Loss with Dapagliflozin Versus Glipizide As Add-On to Metformin Over 4 Years.” American Diabetes Association Scientific Sessions 2015. Abstract #103-OR

[17] Trautmann, M., et al. “Three-year Efficacy and Safety of Exenatide Once Weekly: A Pooled Analysis of 3 Trials.” American Diabetes Association Scientific Sessions 2015. Abstract #1120-P

[18] Busch, R. et al. “Treatment of T2DM Patients with Baseline A1C ≥10% with Exenatide Twice Daily (BID), Exenatide Once Weekly (QW), or Basal Insulin: A Pooled Analysis of 20 Randomized Controlled Trials (RCTs).” American Diabetes Association Scientific Sessions 2015. Abstract #1126-P

[19] Leiter, L, et al. “Saxagliptin and cancer in the SAVOR Trial.” American Diabetes Association Scientific Sessions 2015. Abstract #11-OR

[20] Gause-Nilsson, I., et al. “No Increased Risk of Cardiovascular Events With Dapagliflozin in Elderly Patients with Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension.” American Diabetes Association Scientific Sessions 2015. Abstract #15-OR

[21] Gutierrez, A., et al. “High Cardiovascular Risk of Polyvascular Disease in Diabetes - Insights from SAVOR-TIMI.” American Diabetes Association Scientific Sessions 2015. Abstract #56-OR

[22] Cefalu, W., et al. “Long-term Safety and Efficacy of Dapagliflozin in Patients with T2DM and Cardiovascular Disease.” American Diabetes Association Scientific Sessions 2015. Abstract #106-OR

[23] Dagogo-Jack, S., et al. “Cardiovascular outcomes of Saxagliptin Treatment in African Americans with Type 2 Diabetes: Results from the SAVOR-TIMI 53 Trial.” American Diabetes Association Scientific Sessions 2015. Abstract #15-LB

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

​AstraZeneca today announced that 86 abstracts reporting results of the company’s research and development in diabetes have been accepted for presentationat the 75th Scientific Sessions of the American Diabetes Association (ADA) in Boston, 5-9 June 2015.

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AstraZeneca updates on immuno-oncology combinations development programme at ASCO 2015

Pressmeddelanden   •   2015-06-02 08:04 CEST

AstraZeneca and MedImmune, the Company’s global biologics research and development arm, provided an update on the progress of their combination-focused immuno-oncology pipeline at an investor science event at the American Society of Clinical Oncology (ASCO) meeting in Chicago on 1 June 2015.

Commenting on the Company’s immuno-oncology combination data presented at ASCO, Chief Executive Officer, Pascal Soriot, said: “Immuno-oncology has continued to take centre stage at ASCO this year, as we see more evidence of the significance of this approach for patients. At AstraZeneca we have been clear in our belief that combinations hold the key to transforming clinical practice for the patients not benefiting from the currently-available immunotherapies. The data presented on the combination of MEDI4736 and tremelimumab are truly exciting. As the frontrunner combination of two immuno-oncology molecules in non-small cell lung cancer, it is demonstrating promising clinical activity, in particular in the majority of patients who have low or no PD-L1 expression. With our longstanding expertise in developing highly effective small molecule medicines, including Lynparza and AZD9291, we are now also seeing the potential of combining these targeted medicines with immuno-oncology molecules to deliver efficacious and durable treatment to patients.”

Highlights of the update were:

Data presented on MEDI4736, the Company’s anti-PD-L1 monoclonal antibody, as monotherapy in heavily pre-treated patients with non-small cell lung cancer (NSCLC) are encouraging and suggest that patients with PD-L1 positive tumours may have an improved overall response rate compared to patients with PD-L1 negative tumours, highlighting the unmet medical need for the majority of tumours that are PD-L1 negative.

MEDI4736 is demonstrating strong potential to combine with both immunotherapy and small molecules; AstraZeneca and MedImmune have an extensive development programme underway across multiple tumour types and stages of disease, assessing the potential for immunotherapy to either replace or combine with traditional chemotherapy.

Immuno-oncology combinations

  • The combination of MEDI4736 and tremelimumab (anti-CTLA-4 monoclonal antibody) is demonstrating efficacy regardless of PD-L1 status, showing particular promise for the significant number of patients who fail to respond to anti-PD-1/PD-L1 monotherapy because of their PD-L1 biomarker negative status.
  • The combination of MEDI4736 and tremelimumab is also showing a manageable safety profile, with a discontinuation rate due to related adverse events of only 7%.
  • Nine immuno-oncology clinical trials are planned and underway in NSCLC across early (adjuvant and unresectable stage III) and advanced stages of the disease, including three new studies in first-line metastatic NSCLC announced at ASCO, assessing MEDI4736 in combination with tremelimumab or with chemotherapy.
  • AstraZeneca is exploring the potential clinical benefit of the combination of MEDI4736 and tremelimumab in additional tumour types including squamous cell carcinoma of the head and neck (SCCHN), and announced new tumour types, including gastric, pancreatic and bladder cancer, with the aim of changing the treatment paradigm for patients with a chemotherapy-free regimen.
  • Other immuno-oncology combinations are being explored with the Company’s three OX40 molecules in advanced solid and haematological malignancies, with the optimal potential medicine to be selected by the end of 2015.

Immuno-oncology and small molecule combinations

  • The combination of targeted therapy and immune checkpoint inhibitors has the potential to offer higher response rates and extended duration of responses.
  • MEDI4736 has been shown to be well tolerated in combination at full dose with multiple tyrosine kinase inhibitors (TKIs), with encouraging preliminary efficacy data, including:
    • MEDI4736 and BRAF and MEK inhibitors - early data shows encouragingconfirmed partial response (69%) and disease control rate (100%). 
    • MEDI4736 and AZD9291 - early data indicates the molecules are well tolerated in combination at their Phase III doses, providing early promise of a potential new standard of care in EGFR mutation (EGFRm) and T790M positive NSCLC. EGFR remains one of the major tumour drivers despite progression on EGFR TKIs
    • MEDI4736 and Iressa – early data in EGFRm TKI-naïve NSCLC shows a 64% (9/14) partial response rate. The combination is planned for Phase III study in first line EGFRm NSCLC.
  • In addition, combination trials of MEDI4736 and Lynparzaare planned to start by the third quarter in 2015.

Audio replay and the presentation from the analyst and investor science event will be available on the investor pages of the AstraZeneca website here.

– ENDS –

NOTES TO EDITORS

About AstraZeneca in Oncology

Oncology is a therapeutic area in which AstraZeneca has deep-rooted heritage. It will be potentially transformational for the Company’s future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one-day eliminate cancer as cause of death. By 2020, we are aiming to bring six new cancer medicines to patients.

Our broad pipeline of next-generation investigational medicines is focused on four main disease areas - ovarian, lung, breast, and haematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates.

About MedImmune

MedImmune is the worldwide biologics research and development arm of AstraZeneca. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres. For more information, please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

CONTACTS

Media Enquiries

Esra   Erkal-Paler+44 20 7604 8030   (UK/Global)
Vanessa   Rhodes+44 20   7604 8037 (UK/Global)
Ayesha   Bharmal+44 20   7604 8034 (UK/Global)
Jacob   Lund +46   8 553 260 20 (Sweden)
Michele   Meixell+ 1 302   885 6351 (US)

Investor Enquiries

UK
Thomas Kudsk Larsen+44 20 7604 8199mob: +44 7818 524185
Eugenia LitzRespiratory, Inflammation and   Autoimmunity+44 20 7604 8233mob: +44 7884 735627
Nick StoneCardiovascular and Metabolic Disease+44 17   6326 3994mob: +44 7717 618834
Karl HårdOncology+44 20 7604 8123mob: +44 7789 654364
Craig MarksInfection, Neuroscience and   Gastrointestinal Disease+44 20 7604 8591mob: +44 7881 615764
Christer Gruvris+44 20 7604 8126mob: +44 7827 836825
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Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

AstraZeneca and MedImmune, the Company’s global biologics research and development arm, provided an update on the progress of their combination-focused immuno-oncology pipeline at an investor science event at the American Society of Clinical Oncology (ASCO) meeting in Chicago on 1 June 2015.

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AstraZeneca presents positive data on AZD9291 in first-line EGFR mutated lung cancer at ASCO 2015

Pressmeddelanden   •   2015-05-31 15:06 CEST

Over 80% of patients progression free at 9 months in the first-line treatment of advanced non-small cell lung cancer1


AstraZeneca today announced preliminary efficacy and safety data for AZD9291 in the first-line treatment of epidermal growth factor receptor mutation positive (EGFRm) advanced non-small cell lung cancer (NSCLC). Data showed that 81% (95% confidence interval (CI) 68% to 89%) of patients on a once daily dose of AZD9291 were progression free at 9 months; overall response rate was 73% (95% CI 60% to 84%). The longest duration of response was ongoing at 13.8 months at the time of data cutoff.1

The data from the first-line expansion cohorts of the AURA Phase I study were presented at the annual meeting of the American Society of Clinical Oncology in Chicago. The first-line cohorts included 60 patients with EGFRm advanced NSCLC who received AZD9291 80mg or 160mg once daily. The data are not fully mature with an approximate 11 month median follow up in the 80mg cohort, and an approximate 8.5 month median follow up in the 160mg cohort. The most common adverse events in both cohorts included rash (Grade 3: 0% at 80mg, 3% at 160mg) and diarrhoea (Grade 3: 0% at 80mg, 7% at 160mg).1

“These preliminary data demonstrate the potential of AZD9291 in treatment-naïve advanced NSCLC patients with EGFR mutation. These promising results with AZD9291 will be studied further by the ongoing Phase III FLAURA trial2 in the first-line setting,” said Professor Suresh S. Ramalingam, Chief of Medical Oncology, Emory University School of Medicine, Atlanta, GA, USA, who presented the AURA 1L data and is lead principal investigator for the FLAURA study.

The first-line data from the AURA study build on findings presented in April at the European Lung Cancer Congress (ELCC). Data presented at ELCC showed that previously treated patients with EGFRm advanced NSCLC who also have the T790M resistance mutation achieved a median progression-free survival (PFS) of 13.5 months (95% CI 8.3 months to not calculable) on AZD9291 80mg once daily, based on 38% of patients having tumour progression.3Patients with EGFRm NSCLC are particularly sensitive to treatment with currently available EGFR tyrosine kinase inhibitors (TKIs). However, tumours almost always develop resistance to treatment, leading to disease progression. In approximately two thirds of patientstreated with the approved EGFR-TKIs, gefitinib or erlotinib,this resistance is caused by the secondary T790M mutation.4

Antoine Yver, Head of Oncology, Global Medicines Development, said: “The promising response to first-line treatment with AZD9291 builds on the encouraging efficacy already seen in patients with EGFRm advanced NSCLC who have the T790M resistance mutation, and whose disease has progressed following previous treatment with first-generation EGFR tyrosine kinase inhibitors. We have just been granted accelerated assessment for our upcoming regulatory submission for AZD9291 in Europe. We remain confident that AZD9291 has the potential to deliver early and durable efficacy by targeting both activating and resistance EGFR mutations.”

AZD9291 is being investigated across different lines of therapy, both as monotherapy and in combination with other small molecule and immuno-oncology investigational medicines, to understand its potential benefit for overcoming newly-identified forms of resistance for a broader range of patients. The ongoing TATTON study will investigate the combination of MEDI4736 (anti-PD-L1 immune checkpoint inhibitor), selumetinib (MEK inhibitor), or savolitinib (MET inhibitor; AZD6094) in lung cancer. Data presented at ASCO from the TATTON study showed that AZD9291 has a tolerable safety profile, supporting its investigation in potentially synergistic combinations with other molecules.5A Phase III study (CAURAL) investigating AZD9291 in combination with MEDI4736 as a potential second-line treatment for EGFRm NSCLC patients with the T790M resistance mutation is also planned to start later this year, as part of AstraZeneca’s combination focused development strategy.

An expanded access programme (EAP) for AZD9291 for patients with advanced or metastatic EGFRm, T790M NSCLC has also been initiated in the U.S. Healthcare professionals based in the U.S. seeking more information about the AZD9291 EAP can call 1-800-236-9933. Further information on the EAP is available at www.clinicaltrials.gov (ClinicalTrials.gov identifier: NCT02451852). Additional access programmes will be opened outside of the US shortly and details will be released when information becomes available.

AZD9291 and MEDI4736 are investigational products and are not approved for any indication in any market by any regulatory authority.

-ENDS-

[1] Ramalingam SS et al. AZD9291, A mutant-selective EGFR inhibitor, as first-line treatment forEGFR mutation-positive advanced non-small cell lung cancer (NSCLC): Results from a phase 1 expansion cohort. J Clin Oncol 2015; 33 (suppl; abstr 8000). Data on file [Atlas ID: 787,626.011].

2 Ramalingam SS et al. A randomized, Phase III study (FLAURA) of AZD9291, a novel EGFR-TKI, versus gefitinib or erlotinib in treatment-naïve patients with advanced non-small cell lung cancer and an EGFR-sensitizing mutation. J Clin Oncol2015; 33 (suppl; abstr TPS8102).

3 Jänne PA,et al. A Phase I study of AZD9291 in patients with EGFR-TKI-resistant advanced NSCLC – updated progression-free survival and duration of response data Ann Oncol 2015; 26(Suppl 1): i60, abs LBA3.

4 Yu H, et al, Analysis of Tumor Specimens at the Time of Acquired Resistance to EGFR-TKI Therapy in 155 Patients with EGFR-Mutant Lung Cancers. Clin Cancer Res. 2013:19:2240-7.

5 Oxnard GR et al. Preliminary results of TATTON, a multi-arm phase Ib trial of AZD9291 combined with MEDI4736, AZD6094 or selumetinib in EGFR-mutant lung cancer.J Clin Oncol 2015; 33(suppl; abstr 2509).

6 Cross DA, et al. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. Cancer Discov. 2014;4:1046-61.

7 Szumera-Ciećkiewicz A, et al. EGFR mutation testing on cytological and histological samples in non-small cell lung cancer: a Polish, single institution study and systematic review of European incidence. Int J Clin Exp Pathol. 2013;6:2800-12.

8Ellison G, et al. EGFR mutation testing in lung cancer: a review of available methods and their use for analysis of tumour tissue and cytology samples. J Clin Pathol. 2013;66:79-89.

9 Sharma SV, et al. Epidermal growth factor receptor mutations in lung cancer. Nat Rev Cancer. 2007;7:169-81.

10 Mok TS, et al. Gefitinib or Carboplatin-Paclitaxel in Pulmonary Adenocarcinoma.N Engl J Med.2009;361:947-57.

11 Rosell R, et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial.Lancet Oncol.2012;13:239–46.

NOTES TO EDITORS

About AZD9291

AZD9291 is an investigational, highly selective, irreversible inhibitor of both activating sensitising EGFRm and the resistance mutation, T790M, while sparing the activity of wild type EGFR.6

Patients who have the EGFRm form of NSCLC, which occurs in 10-15 percent of NSCLC patients in Europe7 and 30-40 percent of NSCLC patients in Asia,8 are particularly sensitive to treatment with currently available EGFR TKIs, which block the cell signalling pathways that drive the growth of tumour cells.9-11 However, tumours almost always develop resistance to treatment, leading to disease progression. In approximately two thirds of patients treated with the approved EGFR-TKIs, gefitinib or erlotinib, this resistance is caused by the secondary mutation, T790M.4 Currently, no targeted therapies are approved for the treatment of tumours with this resistance mutation.

AZD9291 has been granted Breakthrough Therapy designation, Orphan Drug and Fast Track status by the US Food and Drug Administration (FDA).

About the AURA First-Line Cohort

Sixty treatment-naïve patients with EGFRm advanced NSCLC were enrolled to receive AZD9291 80mg or 160mg once daily (sequential cohorts).1 At the 15 April 2015 data cut-off, 48 out of 60 patients remained on study treatment across the 80mg and 160mg cohorts.1 Final data are expected August 2015.

Of grade ≥3 adverse events (AEs), one patient reported nausea in the 80mg cohort, and six patients in the 160mg reported rash (1), diarrhoea (2), stomatitis (1) or paronychia (2).1

As of April 7, 2015, of more than 1100 patients across all studies dosed with AZD9291, interstitial lung disease (ILD) grouped term events were reported in approximately 2.6% of patients (31 events): seven Grade 1, seven Grade 2, 16 Grade ≥3; one currently ungraded. Of these, a total of three patients are reported to have died due to ILD (Grade 5).5

About FLAURA

FLAURA is a Phase III, double blind, randomised study which is comparing the efficacy and safety of AZD9291 80mg per day and standard of care (SoC) EGFR-TKI treatment with gefitinib 250mg per day or erlotinib 150mg per day in treatment-naïve patients with locally advanced or metastatic EGFRm NSCLC.2 The primary objective is to compare PFS for AZD9291 with SoC EGFR-TKI, and a key secondary objective is PFS in patients with the T790M resistance mutation.

About TATTON

TATTON is a multi-arm Phase Ib trial investigating AZD9291 80mg in combination with MEDI4736 (anti-PD-L1 mAb), savolitinib (MET inhibitor; AZD6094) or selumetinib (MEK1/2 inhibitor; AZD6244, ARRY-142886) in patients with advanced EGFR mutant lung cancer that has progressed on previous EGFR TKI treatment.5As of 30 April 2015, 71 patients had been enrolled on combination therapy, and doses of selumetinib and savolitinib were escalated to their Phase II monotherapy doses while doses of MEDI4736 were escalated to its Phase III monotherapy dose. The most common adverse events (AEs) included diarrhoea, vomiting, anaemia, constipation, cough and nausea with AZD9291+MEDI4736; diarrhoea, nausea and fatigue with AZD9291+selumetinib; and vomiting, nausea and rash with AZD9291+savolitinib.5

About AstraZeneca in Oncology

Oncology is a therapeutic area in which AstraZeneca has deep-rooted heritage. It will be potentially transformational for the company’s future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one-day eliminate cancer as cause of death. By 2020, we are aiming to bring six new cancer medicines to patients.

Our broad pipeline of next-generation medicines is focused on four main disease areas – ovarian, lung, breast and haematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates. 

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

 

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Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över.

För mer information, se www.astrazeneca.se och www.astrazeneca.com

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AstraZeneca and MedImmune present positive immuno-oncology combination data at ASCO 2015

Pressmeddelanden   •   2015-05-30 15:01 CEST

AstraZeneca and MedImmune, the company’s global biologics research and development arm, today presented encouraging results from their novel combination-focused immuno-oncology portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting 2015.

Overall, data indicated clinical activity with manageable safety profiles for the anti-programmed cell death ligand 1 (PD-L1) monoclonal antibody MEDI4736, both as monotherapy and in combination with other immuno-oncology and small molecule therapies across different tumour types and tumour biology.

MEDI4736 and tremelimumab combination shows clinical activity and tolerability in both PD-L1 positive and PD-L1 negative advanced non-small cell lung cancer (NSCLC) patients; dose confirmed for future studies

Results from the combination study of MEDI4736 and tremelimumab, a cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) monoclonal antibody, in the treatment of advanced NSCLC demonstrated clinical activity in heavily-pretreated patients with a manageable safety profile, establishing appropriate doses to move forward into Phase III combination trials.

MEDI4736 and tremelimumab target two different tumour escape pathways; engaging the immune system to fight the cancer’s immune-evading tactics and maintaining tumour specific T-cell responses.

Data from the Phase Ib open label, dose escalation study of patients with advanced NSCLC, showed that the combination of the PD-L1 and CTLA-4 blockade helped to increase response rates in both PD-L1 biomarker positive and negative patients. 63 patients with 16 weeks or more of follow up were evaluable for clinical activity, 102 patients were evaluated for safety. Notably, the data demonstrated specific clinical activity and tolerability in PDL-1 negative patients, who make up approximately 70% of NSCLC patients and who are less likely to respond to monotherapy. In the PD-L1 negative patient subset, overall response rate (ORR) was 27% (9/33) and disease control rate (DCR) – defined as complete response (CR), partial response (PR) or stable disease (SD) for 16 weeks or more - was 48% (16/33). Overall, nearly half of patients in the study achieved a partial response or stable disease, with ORR of 27% (17/63) and DCR of 41% (26/63). (Antonia et al, abstract #3014).

Overall adverse events (AEs) were manageable and generally reversible using standard treatment guidelines. The most frequently reported treatment related grade 3/4 AEs across all dose cohorts were colitis, diarrhea, elevated lipase and elevated liver function tests. 20/102 patients discontinued the study due to drug-related AEs in this heavily-pretreated disease setting.

The combination data presented at ASCO builds on preliminary results from 18 patients presented at the European Society of Medical Oncology Congress in September 2014.

“The maturing data presented today on the combination of MEDI4736 and tremelimumab are truly exciting - we are starting to see the potential of combination therapy become a reality,” said Dr. Ed Bradley, Senior Vice President and Head of the Oncology Innovative Medicines unit, MedImmune. “We are particularly encouraged by the data indicating that these complementary agents can be combined to increase T-cell activity and improve the clinical activity among the broader patient population of non-small cell lung cancer patients whose tumours are PD-L1 negative and are therefore in need of better treatments.”

A range of doses were identified that provided clinical benefit with acceptable tolerability, with a specific dose and schedule of MEDI4736 20mg every four weeks (12 total doses) and tremelimumab 1mg/kg every four weeks (four total doses) selected for future Phase III combination trials in NSCLC. This decision was supported by data from the trial, which evaluated key indicators of best outcomes for patients (clinical efficacy, tolerability and biologic activity) to ensure that each molecule contributes optimally in the combination. Data indicated that the selected dose of tremelimumab is well tolerated and enhances clinical activity as efficaciously as the other doses studied.

Bahija Jallal, Executive Vice President, MedImmune, said: “We are encouraged by the immunotherapy data being presented here at ASCO 2015, but this is just the tip of the iceberg as we continue to follow the science and build on the diversity of our portfolio with smart combinations. We believe the most powerful combinations will likely target multiple mechanisms in the immune system where cancer wages its battles – T-cell activation, antigen presentation and innate immunity, and the tumour microenvironment. AstraZeneca and MedImmune are uniquely positioned to lead in this area, through our biologics and small molecule portfolio and through targeted collaborations, which allow us to explore novel combinations across this cycle of anti-tumour immunity.”

The study design for the ongoing Phase III ARCTIC trial, designed to evaluate the efficacy and safety of the combination of MEDI4736 and tremelimumab in NSCLC patients with PD-L1-negative tumours, as well as MEDI4736 versus standard of care in NSCLC patients with PD-L1-positive tumours, was also presented at ASCO.(Planchard et al, abstract #TPS8104) A Phase II study of MEDI4736 and tremelimumab as monotherapies and in combination in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN) was also recently started.

Data reinforce the potential of MEDI4736 as a cornerstone for combinations with other immunotherapies and small molecule treatments in multiple tumour types

Other data at ASCO underpinned the potential for MEDI4736 in combination with other immuno-oncology and small molecules in melanoma and lung cancer:

  • Preliminary results from the first ever Phase I triple combination study of MEDI4736 with BRAF (dabrafenib) and/or MEK (trametinib)1 inhibitors in patients with advanced melanoma showed clinical activity with acceptable tolerability, with all three agents at full doses. In patients with advanced BRAF-mutation positive melanoma, confirmed partial responses were seen in 69% of patients (18/26) receiving MEDI4736 plus dabrafenib and trametinib. The disease control rate (CR, PR or SD) was 100% and 89% of responding patients (16/18) had ongoing responses after a median follow-up duration of 7.1 months. Overall, AEs were consistent with the known safety profiles of the combination components, and no exacerbation of immune-related AEs was apparent. (Ribas et al, Abstract #3003; Oral Abstract Session: Developmental Therapeutics – Immunotherapy, Monday, June 1, 2:15 pm)
  • Dose      escalation data from a Phase I study of MEDI4736 in combination with Iressa (gefitinib), AstraZeneca’s      epidermal growth factor receptor (EGFR) mutation positive tyrosine kinase      inhibitor (TKI) in advanced NSCLC showed that treatment was generally well      tolerated, with early treatment activity in heavily pre-treated patients.      (Creelan et al, abstract #3047)
  • Preliminary      results from TATTON, a multi-arm Phase Ib trial of AZD9291 combined with      MEDI4736, AZD6094 or selumetinib in EGFR-mutant lung cancer patients who      have progressed following therapy with an EGFR-TKI, indicated that      MEDI4736 and AZD9291 were tolerated at their      Phase III doses in the combination arm. (Oxnard      et al, Poster #2509)

MEDI4736 monotherapy: data indicate durable responses in multiple tumour types

Increasingly mature data from an ongoing Phase I/II, multicentre, open-label study of MEDI4736 in patients with solid tumours continue to demonstrate durable anti-tumour activity and a manageable safety profile. Analysis of data from 200 response evaluable patients with NSCLC treated with MEDI4736 and with 12 weeks or more of follow-up showed ORR of 16% (27% in PD-L1 positive patients), and DCR (CR, PR or SD for 12 weeks or more) of 42% (48% in PD-L1 positive). ORR was higher in patients with squamous (21%) than non-squamous (13%) disease. Responses were durable with 66% (21/32) ongoing. Drug-related AEs at grade 3 or higher were reported in 8% of patients. (Rizvi et al, Poster #340).

Additional results were also presented on MEDI4736 monotherapy in patients with SCCHN. Of 62 response evaluable patients with 24 weeks or more of follow up, ORR was 11% (18% in PD-L1 positive patients), and DCR (CR, PR or SD for 24 weeks or more) was 15% (18% in PD-L1 positive patients).Responses are ongoing in 71% (5/7) of responding patients. Drug related AEs at grade 3 or higher were reported in 10% of patients. (Segal et al, Poster #337)

Positive progress with companion diagnostic test to help identify patients who are more likely to respond to MEDI4736, reinforcing personalised healthcare approach

A PD-L1 companion diagnostic test that is being developed jointly by Ventana Medical Systems and MedImmune has demonstrated robust, reproducible results as a biomarker to predict response to MEDI4736. Three separate pathologist reviews of 81 patients with NSCLC and 100 patients with SCCHN from MEDI4736 clinical trials showed an overall accuracy of 97% and 91% in the NSCLC and SCCHN samples respectively. The consistency of the results across the pathologist reviews shows that the selected scoring algorithm is precise, reproducible and practical in the clinical setting. In the MEDI4736 monotherapy trials, both NSCLC and SCCHN patients identified as PD-L1 positive by the scoring algorithm had a higher response to MEDI4736 than those identified as PD-L1 negative. (Rebelatto et al, abstract #8033)

– ENDS –

NOTES TO EDITORS

1 Novartis medicines for treatment of patients with metastatic melanoma.

About AstraZeneca in Oncology

Oncology is a therapeutic area in which AstraZeneca has deep-rooted heritage. It will be potentially transformational for the Company’s future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one-day eliminate cancer as cause of death. By 2020, we are aiming to bring six new cancer medicines to patients.

Our broad pipeline of next-generation investigational medicines is focused on four main disease areas - ovarian, lung, breast, and haematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates.

About MedImmune

MedImmune is the worldwide biologics research and development arm of AstraZeneca. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres. For more information, please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

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Om AstraZeneca

Om AstraZeneca

AstraZeneca är ett globalt, innovativt bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom områdena hjärta/kärl, metabolism, andningsvägar, inflammation, autoimmunitet, cancer, infektion och neurovetenskap. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. För mer information, se www.astrazeneca.se och www.astrazeneca.com