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US FDA accepts regulatory submission for Lynparza in metastatic breast cancer and grants priority review

Pressmeddelanden   •   Okt 18, 2017 08:03 CEST

Lynparza has the potential to offer a new treatment option for patients with germline BRCA-mutated, HER2-negative metastatic breast cancer Regulatory submission acceptance is first for a PARP inhibitor beyond ovarian cancer

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US FDA accepts supplemental biologics license application for Imfinzi in locally advanced unresectable non-small cell lung cancer

Pressmeddelanden   •   Okt 17, 2017 08:05 CEST

Imfinzi granted Priority Review Acceptance follows FDA’s Breakthrough Therapy Designation

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AstraZeneca shares its comprehensive scientific approach at the World Conference on Lung Cancer 2017

Pressmeddelanden   •   Okt 16, 2017 08:05 CEST

Early-stage disease - Quality-of-life results from the Imfinzi Phase III PACIFIC trial headline the Presidential Symposium

Overcoming treatment resistance - Novel combination of Tagrisso and savolitinib provide potential new options for EGFRm patients with MET resistance

Maximising outcomes through testing - New analyses support use of blood-based testing to determine eligibility for both Tagrisso and Iressa

Potential of combinations - New data for IO combinations with and without chemotherapy in mesothelioma and NSCLC

AstraZeneca and Medimmune, its global biologics research and development arm, continue to demonstrate their progress in lung cancer research at the IASLC 18th World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Yokohama, Japan, 15-18 October 2017. With 43 data presentations, including 16 oral presentations, AstraZeneca is focusing on four key scientific drivers of progress in lung cancer: treating earlier stages of the disease; strategies to overcome tumour resistance; improved testing to match the right treatments to the right patients; and continued exploration of the potential of immuno-oncology combinations.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said:“The data we are presenting at WCLC 2017 illustrate the science-led strength of our clinical programme focused on tackling multiple mechanisms associated with this complex disease. We are constantly striving to deliver on our ambition of one day eliminating cancer as a cause of death.”

Treating lung cancer at earlier stages of the disease

To date, the majority of research has been focused on metastatic disease, where the medical need is most urgent. But with the potential for clinical benefit becoming clearer in earlier stages of disease, long-term quality of life is an increasingly important component in deciding the right treatment.

At WCLC, patient-reported outcomes from the Phase III Imfinzi PACIFIC trial will be presented during the Presidential Symposium. The PACIFIC trial of Imfinzi (durvalumab) in patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) who have not progressed following platinum-based chemoradiation therapy, is the first to demonstrate superior progression-free survival (PFS) in this setting.

Rina Hui, MD, PhD, clinical associate professor of medicine, Westmead Clinical School at the University of Sydney and Principal Investigator on the trial, said: “As we treat patients with earlier stages of disease and pursue curative intent, quality-of-life considerations definitely affect the choice of treatment. If quality-of-life data support significant clinical benefits, then we may be looking at a new treatment paradigm for these patients.”

Overcoming tumour resistance

More patients taking therapies targeting mutations are experiencing longer periods before their disease worsens; however, tumours often adapt and develop new resistance mechanisms. At WCLC, AstraZeneca is presenting new data on novel combinations that may help overcome a common secondary resistance and established driver of disease progression in patients treated with EGFR TKIs - mesenchymal epithelial transition factor (MET).

Early safety and efficacy results from the multi-arm, Phase Ib TATTON study will be presented, investigating the c-Met receptor tyrosine kinase inhibitor (TKI) savolitinib in combination with EGFR T790M inhibitor Tagrisso (osimertinib) in patients with MET-positive resistance. [Abstract #8985]. These data will be supplemented by the first results of a multi-centre Phase Ib study investigating the combination of savolitinib and Iressa (gefitinib) in a similar patient population. [Abstract #8995].

Myung-Ju Ahn, MD, PhD, Professor, Department of Hematology & Oncology, Samsung Medical Center, Seoul, South Korea, said: “Cancer is stealthy and we must continue to find new ways to combat resistance. The early results for both gefitinib and osimertinib in combination with savolitinib show exciting progress and are an important area of continued focus.”

Testing to identify the most suitable treatment

Biomarker-guided lung cancer research is continuing to improve ways to identify patients who are most likely to benefit from treatment with precision medicines. In NSCLC, this has meant improving the accuracy and availability of blood-based testing to facilitate diagnosis and identification of the most suitable treatments throughout the disease continuum. At WCLC, AstraZeneca is presenting progress in ctDNA testing in EGFRm NSCLC across multiple lines of therapy and technologies.

In the 1st-line setting, new analyses across the Tagrisso FLAURA [Abstract #8978] and Iressa BENEFIT [Abstract #9278] trials reveal good concordance between tissue and plasma ctDNA testing, and support the utility of blood-based testing to determine eligibility for both Tagrisso and Iressa. In addition, concordance studies comparing multiple plasma ctDNA diagnostics in two different studies of Tagrisso [Abstract #8984 and #9811] in the 2nd line setting continue to build understanding of the comparability of different technologies and expand testing across platforms.

Jhanelle Gray, MD, Medical Oncologist and Director of Clinical Research in the Department of Thoracic Oncology at H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida, said: “Testing continues to be a critical part of lung cancer care, but the rapid development and evolution of multiple testing modalities and platforms can be challenging for physician teams to manage. Continued understanding of how assays compare builds confidence in treatment decisions, leading to better patient outcomes”

Combining with IO

As the promise of IO continues to build through the use of monotherapies, the next era in cancer control may involve combinations with a goal of achieving long-term survival for a broader population of patients. At WCLC, AstraZeneca is sharing results from two early trials of checkpoint inhibitor combinations, with and without chemotherapy.

  • When combined with chemotherapy, Imfinzi with or without tremelimumab could be administered safely and demonstrated encouraging preliminary clinical activity in patients with NSCLC in a study conducted by the Canadian Cancer Trials Group [Abstract #8700].
  • The Phase II, open-label, NIBIT-MESO-1 study [Abstract #9202] of Imfinzi plus tremelimumab as 1st- or 2nd-line treatment in patients with malignant mesothelioma demonstrated a safety profile consistent with our previous observations/publications in NSCLC, and clinical activity in this difficult-to-treat cancer.

Rosalyn A. Juergens MD., PhD. Assistant Professor, Department of Oncology. McMaster University, Canada said: “As we continue to explore the full benefit of immunotherapies, the promise of combinations is really starting to be seen for patients who may not be expected to benefit from the current monotherapies. We continue to push research boundaries in this area with the hope that we can make a real difference to patients in need.”

– ENDS –

NOTES TO EDITORS

Select AstraZeneca/MedImmune Presentations atWCLC 2017. For the full listing of abstracts at WCLC, please visit http://library.iaslc.org/conference-program?product_id=7

Lead author Abstract title Presentation details
Early Stage Lung Cancer
Hui, R Patient-reported outcomes with durvalumab after concurrent chemoradiation in Stage III unresectable NSCLC: data from PACIFIC Oral Presidential Symposium Tuesday 17 October

Presentation Time: 08:15-09:45

Location: TBD

Abstract #10762

Overcoming Tumour Resistance Mechanisms

Yang, J-J A phase Ib trial of savolitinib plus gefitinib for patients with EGFR-mutant MET-amplified advanced NSCLC Oral EGFR TKI Resistance Tuesday 17 October

Presentation Time: 11:00-12:30

Location: Room 301 and 302

Abstract #8995

Anh, M-J

TATTON Phase Ib expansion cohort: osimertinib plus savolitinib for pts with EGFR-mutant MET-amplified NSCLC after progression on prior EGFR-TKI Oral EGFR TKI Resistance Tuesday 17 October

Presentation Time: 11:00-12:30

Location: Room 301 and 302

Abstract #8985

Diagnostic testing in EGFRm NSCLC

Ahn, M-J Detection of EGFR mutations from plasma ctDNA in the osimertinib Phase III trial (AURA3): comparison of three plasma assays Oral Liquid Biopsy for Genomic Alterations Wednesday 18 October

Presentation Time: 11:00-12:30

Location: F201 and F202 (Annex Hall)

Abstract #8984

Wang, J Gefitinib as first-line treatment of plasma ctDNA EGFR mutation-positive NSCLC detected by ddPCR: BENEFIT study (CTONG1405) Oral Emerging Diagnostics/Biomarkers in NSCLC Tuesday 17 October

Presentation Time: 11:00-12:30

Location: Room 313 and 314

Abstract #9278

Gray, JE

Osimertinib vs SoC EGFR-TKI as first-line treatment in patients with EGFRm advanced NSCLC (FLAURA): plasma ctDNA analysis Oral Next Generation TKI Monday 16 October

Presentation Time: 15:45-17:30

Location: Room 301 and 302

Abstract #8978

Yokoyama, T The usefulness of liquid biopsy for ctDNA in patients with EGFR-mutant NSCLC during and after treatment with EGFR-TKIs Poster Advanced NSCLC Wednesday 18 October

Presentation Time: 9:30-16:00

Location: Exhibit Hall (Hall B and C)

Abstract #9811

IO Combinations

Juergens RA Durvalumab ± tremelimumab with platinum-doublets in non-small cell lung cancer: Canadian Cancer Trials Group study IND.226 Oral Immunotherapy Tuesday 17 October

Presentation Time: 11:00-12:30

Location: Room 303 and 304

Abstract #8700

Calabro, L Tremelimumab in combination with durvalumab in first or second-line mesothelioma patients: the NIBIT-MESO-1 study Oral Mesothelioma Bench to Bedside Wednesday 18 October

Presentation Time: 11:00-12:30

Location: Room 315

Abstract #9202

About AstraZeneca in Lung Cancer

AstraZeneca is committed to developing therapies to help every patient with lung cancer. We have two approved therapies and a growing pipeline that targets genetic changes in tumour cells and boosts the power of the immune response against cancer. Our unrelenting pursuit of science aims to deliver more breakthrough therapies with the goal of extending and improving the lives of patients across all stages of disease and lines of therapy.

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 five 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, Tumour Drivers 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 the WCLC

The World Conference on Lung Cancer (WCLC) is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting over 6,000 researchers, physicians and specialists from more than 100 countries. The goal is to disseminate the latest scientific achievements; increase awareness, collaboration and understanding of lung cancer; and to help participants implement the latest developments across the globe. Organized under the theme of “Synergy to Conquer Lung Cancer,” the conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit http://www.wclc2017.iaslc.org.

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.com and 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

​Early-stage disease - Quality-of-life results from the Imfinzi Phase III PACIFIC trial headline the Presidential Symposium Overcoming treatment resistance - Novel combination of Tagrisso and savolitinib provide potential new options for EGFRm patients with MET resistance

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The European Medicines Agency accepts marketing authorisation application for Imfinzi in locally-advanced unresectable non-small cell lung cancer

Pressmeddelanden   •   Okt 09, 2017 08:06 CEST

AstraZeneca, along with MedImmune, its global biologics research and development arm, has announced that the European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Imfinzi (durvalumab) for the treatment of patients with locally-advanced (Stage III), unresectable non-small cell lung cancer

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Tagrisso granted breakthrough therapy designation by US FDA for the 1st-line treatment of patients with EGFR mutation-positive non-small cell lung cancer

Pressmeddelanden   •   Okt 09, 2017 08:05 CEST

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).

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TAGRISSO INGÅR I LÄKEMEDELSFÖRMÅNERNA

Pressmeddelanden   •   Okt 03, 2017 14:56 CEST

Tandvårds- och läkemedelsförmånsverket, TLV, har beslutat att AstraZenecas läkemedel Tagrisso® (osimertinib) från och med den 1 oktober ingår i läkemedelsförmånerna för vuxna patienter med lokalt avancerad eller metastaserad epidermal tillväxtfaktorreceptor (EGFR) T790M mutationspositiv icke-småcellig lungcancer (NSCLC).

Osimertinib är sedan februari 2016 godkänt för patienter med T790M mutationspositiv icke-småcellig lungcancer, oberoende av tidigare behandling med en EGFR-tyrosinkinashämmare (TKI). Möjligheten att behandla med osimertinib beror på mutationsstatus, vilken fastställs genom ett validerat diagnostiskt test baserat på prov av tumörvävnad eller plasma.

- Beslutet att osimertinib nu ingår i läkemedelsförmånen är positivt för den aktuella patientgruppen. Osimertinib har visat sig ha bättre effekt samt färre biverkningar jämfört med cytostatika som tidigare var huvudalternativet för dessa patienter, säger Ronny Öhman, Överläkare på Skånes Universitetssjukhus i Lund.

Som underlag för TLV:s beslut finns kliniska data från studierna AURA31, AURA2/AURAext2 samt IMPRESS3. De viktigaste kliniska effektmåtten i den hälsoekonomiska modellen är progressionsfri överlevnad (PSF) och total överlevnad (OS) från ovan nämda studier.

För att ta del av underlag och skäl för TLV:s beslut besök hemsidan www.tlv.se

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, kommunikationschef AstraZeneca Nordic-Baltic, petra.eurenius@astrazeneca.com, mobil 0709-18 65 62

www.astrazeneca.se

Referenser

1.Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer. Mok TS, Wu Y-L, Ahn M-J et al. NEng J Med 2016 Dec 6. DOI: 10.1056/NEJMoa1612674

  • 2.TAGRISSO SPC: www.fass.se
  • 3.Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial. Soria et al. Lancet Oncol 2015; 990-998

Approval no. SE-2140, 10,2017

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

Tandvårds- och läkemedelsförmånsverket, TLV, har beslutat att AstraZenecas läkemedel Tagrisso® (osimertinib) från och med den 1 oktober ingår i läkemedelsförmånerna för vuxna patienter med lokalt avancerad eller metastaserad epidermal tillväxtfaktorreceptor (EGFR) T790M mutationspositiv icke-småcellig lungcancer (NSCLC).

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Bevespi Aerosphere demonstrates statistically significant improvement in lung function in patients with COPD

Pressmeddelanden   •   Sep 25, 2017 08:03 CEST

hase III, PINNACLE 4 trial demonstrates positive top-line results compared to its monotherapy components and placebo Trial supports filing of new drug applications in Japan and China​

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Bydureon EXSCEL trial demonstrates favourable cardiovascular (CV) safety profile and fewer CV events in patients with type-2 diabetes at wide range of CV risk

Pressmeddelanden   •   Sep 14, 2017 18:27 CEST

​Largest and most inclusive patient population of any GLP-1 CV outcomes trial with 14,500 patients at 687 trial sites across 35 countries Full trial results presented at the annual meeting of the European Association for the Study of Diabetes (EASD) and simultaneously published in the New England Journal of Medicine

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AstraZeneca and Aspen enter agreement for remaining rights to anaesthetic medicines

Pressmeddelanden   •   Sep 14, 2017 08:03 CEST

Agreement builds on 2016 collaboration on commercialisation rights to anaesthetic medicines in markets outside the US

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AstraZeneca presents new results identifying severe asthma patients who would benefit most from Benralizumab

Pressmeddelanden   •   Sep 11, 2017 10:11 CEST

Further analysis of the Phase III trials, SIROCCO and CALIMA, reinforces benralizumab’s efficacy and identifies more frequent prior exacerbations and/or greater baseline blood eosinophil count as key predictors of an enhanced treatment effect. Findings pave the way for a personalised treatment approach to guide more precise selection of the benralizumab-responsive patient.

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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