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AstraZenecas observationsstudie CVD-REAL visar att SGLT-2-hämmare signifikant minskade antalet sjukhusinläggningar på grund av hjärtsvikt och antalet dödsfall jämfört med andra läkemedel vid diabetes typ 2

Pressmeddelanden   •   Mar 21, 2017 15:26 CET

Banbrytande data från en internationell observationsstudie av över 300 000 patienter med typ-2 diabetes visar att behandling med SGLT-2-hämmare minskade risken för sjukhusinläggning på grund av hjärtsvikt med 39% och den totala mortaliteten med 51%.

Vid American College of Cardiology 66th Annual ScientificSession den 19 mars presenterades resultaten från CVD-REAL, den första stora observationsstudien från klinisk verklighet (Real World Evidence) i sitt slag. Studiens syfte var att utvärdera risken för sjukhusinläggning på grund av hjärtsvikt respektive dödsfall oavsett orsak hos patienter med typ-2 diabetes som behandlas med en modernare grupp av diabetesläkemedel, så kallade SGLT-2-hämmare (SGLT-2i).1

CVD-REAL-studien utvärderade data från fler än 300 000 patienter i sex länder varav 87% inte hade någon tidigare känd hjärt-kärlsjukdom. Resultaten visar att behandling av patienter med typ-2 diabetes med SGLT-2i-läkemedel – dapagliflozin, canagliflozin, empagliflozin – minskade antalet sjukhusinläggningar på grund av hjärtsvikt med 39% (p < 0,001) samt antalet dödsfall oavsett orsak med 51% (p < 0,001), jämfört med andra läkemedel mot typ-2 diabetes. För det sammansatta effektmåttet (sjukhusinläggning på grund av hjärtsvikt och dödsfall oavsett orsak) var minskningen 46% (p < 0,001).1

Cirka 415 miljoner vuxna individer över hela världen har diabetes och antalet beräknas öka till 642 miljoner fram till år 2040 (1 av 10 vuxna).2 Personer med typ-2 diabetes har en 2–3 gånger högre risk för att få hjärtsvikt och löper ökad risk att drabbas av hjärtinfarkt eller stroke, och cirka 50% av dödsfallen hos personer med typ-2 diabetes orsakas av hjärt-kärlsjukdom.3,4,5

”Dessa data talar för att klassen SGLT-2 hämmare minskar risken för sjukhusinläggning på grund av hjärtsvikt och död i en bred diabetespopulation. Kliniskt är det av stor vikt att blodsockersänkande läkemedel är hjärtsäkra och även minskar risken för hjärtkärlkomplikationer och död.6,7 Resultaten är förvånansvärt lika en tidigare stor klinisk studie.8 Studien CVD-REAL är ett fantastiskt internationellt samarbete där vi visar att registerdata är av betydelse för att studera behandling i ett vardagligt perspektiv, utanför de ramar som sätts för en klinisk studie”, säger Anna Norhammar, medlem i den vetenskapliga kommittén för CVD-REAL, docent i kardiologi Karolinska Institutet och överläkare Capio S:t Görans sjukhus.

Analysen av antalet sjukhusinläggningar på grund av hjärtsvikt genomfördes med hjälp av avidentifierade patientdata från Danmark, Tyskland, Norge, Sverige, Storbritannien och USA. I den analyserade datan behandlades 41,8 % av patienterna med dapagliflozin, 52,7 % med canagliflozin och 5,5 % med empagliflozin. Analysen av dödsfall oavsett orsak genomfördes med hjälp av avidentifierade patientdata från Danmark, Norge, Sverige, Storbritannien och USA, där 51,0 % av patienterna behandlades med dapagliflozin, 42,3 % med canagliflozin och 6,7 % med empagliflozin.

Det här är den första av flera jämförande analyser av CVD-REAL. Insamlingen av ytterligare observationell data pågår och framtida analyser kommer även inkludera data från andra länder. Alla data som användes för studien har samlats in från avidentifierade källor, däribland patientjournaler, försäkringsdatabaser och nationella register.Analysen har validerats av den oberoende akademiska statistikgruppen vid St. Luke's Mid America Heart Institute, Kansas City, USA.

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden - andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena autoimmunitet, neurovetenskap och infektion. 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 eller följ oss på twitter.Https:/twitter.com/AstraZenecaSE.

Kontaktperson:

Petra Eurenius, External Communications AstraZeneca Nordic-Baltic, +46 709 186562.

Petra.eurenius@astrazeneca.com

www.astrazeneca.se

NOTES TO EDITORS

About SGLT-2 inhibitorsDapagliflozin (Forxiga) is part of a class of medicines called sodium-glucose cotransporter 2 inhibitors (SGLT-2i) used to manage type-2 diabetes, which remove glucose via the kidneys. Dapagliflozin is not indicated to reduce the risk of cardiovascular events, death, heart failure or the progression of chronic kidney disease.

About AstraZeneca in Diabetes

AstraZeneca is pushing the boundaries of science with the goal of developing life-changing medicines that aim to reduce the global burden and complications of diabetes. As a core therapy area for the company, we are focusing our research and development efforts on

diverse populations and patients with significant co-morbidities, such as cardiovascular disease, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.

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 product approaches to help more patients achieve treatment success earlier in their disease progression. Our ambition is to reduce the long-term impact of diabetes.

About AstraZeneca in Cardiovascular and Metabolic Diseases

Cardiovascular, renal and metabolic diseases are key areas of focus for AstraZeneca as part of the company’s strategy for achieving scientific leadership and returning to growth. By collaborating across therapeutic disciplines within the CVMD therapy area, we are addressing the underlying disorders that drive CVMD risk, with the goal of reducing morbidity, mortality and organ damage through innovative therapies. Recognising the growing unmet needs and challenges faced by the millions of people worldwide living with these interrelated diseases, we are determined to understand how they interact and impact one another – and how they can be treated together to save more patients’ lives.

Referenser

1.The CVD-REAL Study: Lower Rates of Hospitalization for Heart Failure in New Users of SGLT-2 Inhibitors Versus Other Glucose Lowering Drugs — Real-World Data From Four Countries and More Than 360,000 Patients; presented 19 March at ACC 2017

2.International Diabetes Federation. Facts and Figures. Accessed 15 March 2017http://www.idf.org/WDD15-guide/facts-and-figures.html

3.Nwaneri C, Cooper H, Bowen-Jones D. Mortality in type 2 diabetes mellitus: magnitude of the evidence from a systematic review and meta-analysis. The British Journal of Diabetes & Vascular Disease. 2013;13(4):192-207

4.Morrish NJ, et al. Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001;44 Suppl 2:S14-21.

5.World Heart Federation. Diabetes as a risk factor for cardiovascular disease. Available from:http://www.world-heart-federation.org/cardiovascular-health/cardiovascular-disease-risk-factors/diabetes/

6.World Health Organization. Media Centre: Diabetes Fact Sheet. Reviewed November 2016. Accessed 9 March 2017. http://www.who.int/mediacentre/factsheets/fs312/en/

7.American Diabetes Association. The Cost of Diabetes. Accessed 9 March 2017http://www.diabetes.org/advocacy/news-events/cost-of-diabetes.html?referrer=https://www.google.com/

8.Zinman B, et al. Empagliflozin, Cardiovascular Outcomes and Mortality in Type 2 Diabetes. New Engl Journal of Medicine. 2015 Nov 26;373(22):2117-28

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden - andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

Banbrytande data från en internationell observationsstudie av över 300 000 patienter med typ-2 diabetes visar att behandling med SGLT-2-hämmare minskade risken för sjukhusinläggning på grund av hjärtsvikt med 39% och den totala mortaliteten med 51%.

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AstraZeneca’s CVD-real study shows SGLT-2 inhibitors significantly reduced death and hospitalisations for heart failure versus other type-2 diabetes medicines

Pressmeddelanden   •   Mar 19, 2017 19:02 CET

Landmark real-world evidence from an international study of more than 300,000 patients with type-2 diabetes showed treatment with SGLT-2 inhibitors reduced all- cause mortality by 51% and risk of hospitalisation for heart failure by 39%

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AstraZeneca and Circassia enter strategic collaboration in respiratory disease

Pressmeddelanden   •   Mar 17, 2017 08:07 CET

Circassia will lead promotion of Tudorza and prepare for potential launch of Duaklir in the US

Strategic collaboration further sharpens AstraZeneca’s respiratory focus on Symbicort, Bevespi Aerosphere, benralizumab and other development programmes

AstraZeneca today announced it has entered a strategic collaboration with Circassia Pharmaceuticals plc, a respiratory biopharmaceutical company, for the development and commercialisation of Tudorza and Duaklir* in the US. Tudorza and Duaklir are inhaled respiratory medicines for the treatment of chronic obstructive pulmonary disease (COPD). Tudorza was approved and launched in the US in 2012. Duaklir is expected to be submitted for US regulatory review in 2018.

Under the terms of the collaboration, Circassia will lead the promotion of Tudorza in the US and has been granted an option to gain the full commercial rights in the future. Circassia has also been granted the rights to Duaklir in the US. AstraZeneca will receive a minority equity stake in Circassia. AstraZeneca will complete ongoing development activities and continue to manufacture and supply both medicines.

This collaboration reinforces AstraZeneca's commitment to maximise patient access and value across the portfolio in all geographic regions, in particular as the pipeline is delivering numerous new medicines and technologies, driven by increased R&D productivity. Circassia has ambitious plans to strengthen its respiratory presence in the US, which provides the potential to expand the collaboration in the future.

Mark Mallon, Executive Vice President, Global Product & Portfolio Strategy at AstraZeneca, said: “Tudorza and Duaklir are important components of AstraZeneca’s respiratory franchise globally and this collaboration will support their commercialisation in the US for the benefit of the millions of COPD patients. It also further sharpens our focus on Symbicort, Bevespi Aerosphere, benralizumab and other respiratory development programmes. Circassia will be an important strategic partner for AstraZeneca in the US and we look forward to working closely together.”

Steve Harris, Chief Executive of Circassia, said: “This proposed transaction is an ideal fit with Circassia’s strategy and respiratory focus. It represents a transformational opportunity for the company. As part of the long-term strategic collaboration with AstraZeneca, we will immediately double our US sales force to promote Tudorza as our priority, as well as our existing NIOX® products, transforming Circassia into a world-class respiratory business.”

Financial considerations
The agreement is expected to complete in the second quarter of 2017, subject to approval by shareholders of Circassia and customary closing conditions.

Under the terms of the agreement, AstraZeneca will receive $50 million in Ordinary Shares in Circassia, calculated by reference to the lower of the weighted average share price of Circassia over the period 20 days (i) prior to signing or (ii) prior to closing (subject to a maximum number of shares). Circassia will also pay $100 million at the earlier of approval of Duaklir in the US or 30 June 2019. Should Circassia decide to exercise the option to sub-license the commercial rights to Tudorza in the US, Circassia will pay up to a further $80 million.

The two companies will share US profits from Tudorza equally. AstraZeneca will continue to book US Product Sales of Tudorza until Circassia’s potential exercise of the option. Circassia will pay AstraZeneca tiered percentage royalties on potential future US sales of Duaklir. In addition, Circassia will contribute up to $62.5 million towards the development activities for the medicines.

As AstraZeneca will retain a significant, ongoing interest in the medicines, income will be reported as Externalisation Revenue. This includes an expected $60 million at closing, as well as any potential future royalties, deferred income and any future payment for the option to gain the US commercial rights to Tudorza. Any potential future supply of the medicines to Circassia will be reported as Product Sales.

The agreement does not impact AstraZeneca’s financial guidance for 2017.

– ENDS –

NOTES TO EDITORS

About Tudorza and Duaklir

Tudorza and Duaklir are inhaled respiratory medicines for the treatment of COPD. Tudorza has been approved and marketed in the United States since 2012. Duaklir is approved and marketed in the European Union and a number of additional rest of the world countries, and is subject to two ongoing clinical trials to support a planned regulatory submission to the US FDA. Both medicines are presented as a dry powder for inhalation and are delivered via a breath-actuated multi-dose dry powder inhaler, Pressair. The Pressair device is marketed in some countries under the trade name Genuair.

*Duaklir is a registered trademark in certain European countries. The US trademark is to be confirmed.

About Circassia

Circassia is a specialty pharmaceutical business with established commercial infrastructure, marketed products and a portfolio of particle-engineered treatments targeting major market opportunities. Circassia sells its novel, market-leading NIOX® asthma management products directly to specialists in the United States, United Kingdom and Germany. Its products are also promoted in a number of other countries by the Company’s network of partners.

Circassia's broad-based development pipeline includes a range of respiratory medicines. The Company's lead asthma treatment, Fliveo®, targets substitution of GSK's Flixotide® pMDI and is approved in the UK. Circassia is also developing a direct substitute for Seretide® pMDI, Seriveo®. In addition, the Company's pipeline includes a number of inhaled medicines for chronic obstructive pulmonary disease, including single and combination dose products. For more information on Circassia please visit www.circassia.com.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of Autoimmunity, Neuroscience and Infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.comand follow us on Twitter @AstraZeneca.

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Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden - andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

​Circassia will lead promotion of Tudorza and prepare for potential launch of Duaklir in the US Strategic collaboration further sharpens AstraZeneca’s respiratory focus on Symbicort, Bevespi Aerosphere, benralizumab and other development programmes

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AstraZeneca receives Complete Response Letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for hyperkalaemia

Pressmeddelanden   •   Mar 17, 2017 08:04 CET

AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate).

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Fas III-studien SOLO-2 visar på förlängd progressionsfri överlevnad med Lynparza som underhållsbehandling av BRCA-muterad äggstockscancer

Pressmeddelanden   •   Mar 14, 2017 19:32 CET

Lynparza minskade risken för sjukdomsprogression med 70 %, med en prövarbedömd progressionsfri överlevnad på 19,1 månader, jämfört med 5,5 månader för placebo En blindad, oberoende central granskning visade en progressionsfri överlevnad på 30,2 månader, jämfört med 5,5 månader för placebo

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Medimmune and Sanofi Pasteur form alliance to develop and commercialise potential next-generation respiratory syncytial virus antibody MEDI8897

Pressmeddelanden   •   Mar 03, 2017 08:05 CET

​MedImmune, the global biologics research and development arm of AstraZeneca, and Sanofi Pasteur, the vaccines division of Sanofi, today announced an agreement to develop and commercialise MEDI8897 jointly.

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FDA approves once-daily Qtern (dapagliflozin and saxagliptin) tablets for adults with type-2 diabetes

Pressmeddelanden   •   Feb 28, 2017 08:06 CET

Qtern fixed-dose combination will provide an additional oral medicine option for patients taking Farxiga (dapagliflozin) to improve blood sugar level

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AstraZeneca enters agreement with TerSera Therapeutics for Zoladex in the US and Canada

Pressmeddelanden   •   Feb 20, 2017 08:16 CET

AstraZeneca to receive upfront payment and sustainable and ongoingsales-based income

Agreement expands the commercial potential of Zoladex in US and Canada

AstraZeneca today announced that it has entered into an agreement with TerSera Therapeutics LLC (TerSera) for the commercial rights to Zoladex (goserelin acetate implant) in the US and Canada. Zoladex is an injectable luteinising hormone-releasing hormone agonist, used to treat prostate cancer, breast cancer and certain benign gynaecological disorders. It was first approved in the US and Canada in 1989.

TerSera will pay AstraZeneca $250 million upon completion. AstraZeneca will also receive sales-related income through milestones totalling up to $70 million, as well as recurring quarterly sales-based payments at mid-teen percent of Product Sales. AstraZeneca will also manufacture and supply Zoladex to TerSera, providing a further source of ongoing income from Zoladex in the US and Canada.

Mark Mallon, Executive Vice President, Global Product & Portfolio Strategy at AstraZeneca said: “This agreement allows us to retain a significant share of the value of Zoladex in the US and Canada, while concentrating our resources on our innovative New Oncology medicines. It also ensures patients have continued access to Zoladex, with TerSera’s dedicated focus helping to expand the potential of this important medicine.”

Ed Fiorentino, Chairman and CEO of TerSera Therapeutics, said: “We are very pleased to be partnering with AstraZeneca, and investing in the future growth of Zoladex, which continues to be a mainstay of treatment for its indicated uses.”

Financial considerations

In 2016, Product Sales for Zoladex were $69 million in the US and Canada, and $816 million globally. AstraZeneca will continue to commercialise Zoladex in all markets outside the US and Canada. The transaction is expected to complete in the first quarter of 2017, subject to customary closing conditions. AstraZeneca will maintain a significant ongoing interest in Zoladex in the US and Canada through the sustainable and ongoing income from the upfront, milestone, quarterly sales-based and supply payments received from TerSera. The $250 million upfront, $70 million milestone payments and double-digit percentage quarterly sales-based payments received from TerSera will be reported as Externalisation Revenue in the Company’s financial statements.

The agreement does not include the transfer of any AstraZeneca employees or facilities and does not impact AstraZeneca’s financial guidance for 2017.

– ENDS –

NOTES TO EDITORS

About TerSera Therapeutics LLC

TerSera Therapeutics LLC acquires, develops and markets specialty pharmaceutical products with a focus on select therapeutic areas. Its mission is to provide products which truly make a difference for patients. For more information about TerSera Therapeutics, please visit www.tersera.com.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.comand follow us on Twitter @AstraZeneca.

Media Enquiries
Esra Erkal-Paler UK/Global +44 203 749 5638
Vanessa Rhodes UK/Global +44 203 749 5736

Karen Birmingham

UK/Global

+44 203 749 5634

Rob Skelding

UK/Global

+44 203 749 5821

Jacob Lund

Sweden

+46 8 553 260 20

Michele Meixell

US

+1 302 885 2677

Investor Relations

Thomas Kudsk Larsen +44 203 749 5712
Craig Marks Finance, Fixed Income, M&A +44 7881 615 764
Henry Wheeler Oncology +44 203 749 5797
Mitchell Chan Oncology +1 240 477 3771
Lindsey Trickett Cardiovascular & Metabolic Diseases +1 240 543 7970
Nick Stone Respiratory +44 203 749 5716
Christer Gruvris Autoimmunity, Neuroscience & Infection +44 203 749 5711
US toll free +1 866 381 7277

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden - andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

​AstraZeneca to receive upfront payment and sustainable and ongoingsales-based income Agreement expands the commercial potential of Zoladex in US and Canada

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Updated durvalumab monotherapy data confirm results in urothelial bladder cancer

Pressmeddelanden   •   Feb 17, 2017 18:17 CET

AstraZeneca and its global biologics research and development arm, MedImmune, today announced updated efficacy and safety data for durvalumab in patients with locally-advanced or metastatic urothelial cancer (UC).

Updated results from the Phase I/II trial, presented at the 2017 ASCO Genitourinary Cancers Symposium, showed an objective response rate (ORR) of 20.4% in all evaluable patients (n=103) (95% confidence interval (CI): 13.1%, 29.5%) and 31.1% (95% CI: 19.9%, 44.3%) in patients whose tumours express PD-L1*. At the time of data cut-off, median overall survival (OS) was 14.1 months (95% CI: 4.7, not estimable).

David Berman, Senior Vice President, Head of Oncology Innovative Medicines at MedImmune, said: “The durable responses observed in this larger data set from Study 1108 confirm the promising efficacy we’ve already seen for durvalumab in patients with advanced bladder cancer. We are continuing to test durvalumab in combination with tremelimumab and as monotherapy in the bladder cancer 1st-line setting in our ongoing Phase III DANUBE trial.”

Durvalumab 10mg/kg was administered intravenously every two weeks for up to 12 months, and demonstrated a manageable safety profile among all patients (n=191). The most common adverse events (AEs) reported in 5% or more of patients were fatigue (19.4%), decreased appetite (9.4%), diarrhoea (8.4%), rash (7.3%), nausea (6.8%), arthralgia (5.8%), pyrexia (5.8%) and pruritus (5.2%). Grade 3 or 4 adverse events occurred in 6.8% of patients, and three patients discontinued treatment due to AEs.

Professor Thomas Powles, Director of Barts Cancer Centre, London, UK, said: “The clinical efficacy of durvalumab in patients with advanced UC is particularly encouraging. For the past three decades we’ve seen limited progress in therapy for bladder cancer patients, and there remains significant unmet need for new treatment options.”

In December 2016, AstraZeneca received FDA acceptance of review of the Biologics License Application (BLA) for durvalumab in patients with locally-advanced or metastatic urothelial carcinoma, whose disease has progressed during or after one standard platinum-based regimen and was granted Priority Review. The urothelial cancer cohort from Study 1108 formed the basis for the BLA submission, which follows the FDA’s Breakthrough Therapy Designation for durvalumab for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen.

The combination of durvalumab and tremelimumab is also being studied in non-small cell lung cancer, head and neck squamous cell carcinoma, gastric cancer, pancreatic cancer, hepatocellular carcinoma and haematological malignancies. AstraZeneca currently has more than 30 ongoing durvalumab clinical trials in combination with other IO agents and targeted therapies.

– ENDS –

NOTES TO EDITORS

*PD-L1 expression was defined as 25% or more PD-L1 staining in tumour cells (TCs) or immune cells (ICs) as assessed through use of the Ventana® SP263 PD-L1 Assay.

About durvalumab

Durvalumab, a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumour's immune-evading tactics and inducing an immune response.

Durvalumab is also being studied in the first line treatment of patients with unresectable and metastatic bladder cancer as a monotherapy and in combination with tremelimumab, a checkpoint inhibitor that targets CTLA-4, as part of the DANUBE Phase III trial, which enrolled its first patient during the final quarter of 2015. Additional clinical trials are ongoing to investigate durvalumab as monotherapy or in combination with tremelimumab in non-small cell lung cancer, head and neck squamous cell carcinoma, bladder, gastric, pancreatic, hepatocellular carcinoma and blood cancers.

AstraZeneca’s approach to Immuno-Oncology (IO)

Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments across multiple tumour types.

We are pursuing a comprehensive clinical trial programme that includes durvalumab (PD-L1) monotherapy and durvalumab in combination with tremelimumab (CTLA-4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small targeted molecules from across our oncology pipeline, and with those of our research partners, may provide new treatment options across a broad range of tumours.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, the genetic drivers of cancer and resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology; Respiratory, Cardiovascular & Metabolic Diseases; and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK, and Mountain View, CA. For more information, please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.comand follow us on Twitter @AstraZeneca.

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Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden - andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se

Updated Study 1108 data presented at ASCO GU demonstrate compelling clinical activity in patients that had previously progressed during or after one line of standard platinum-based chemotherapy

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Lynparza meets primary endpoint in phase III trial in BRCA-mutated metastatic breast cancer

Pressmeddelanden   •   Feb 17, 2017 08:03 CET

​Lynparza provided a statistically-significant improvement in progression-free survival compared to chemotherapy First positive randomised trial to evaluate the efficacy and safety of a PARP inhibitor beyond ovarian cancer

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Om AstraZeneca

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre terapiområden - andningsvägar, hjärta/kärl/metabolism och cancer men är också selektivt aktiv inom områdena autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt i över 100 länder och våra innovativa läkemedel används av miljontals patienter världen över. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se