AstraZeneca takes latest scientific advances in oncology to major US and European congresses

Tagrisso scientific updates include results of AURA3 trial in patients with lung cancer, and Phase II efficacy data on CNS metastases

New analyses of Phase III FALCON trial will extend understanding of Faslodex
in 1st-line treatment of advanced breast cancer

New acalabrutinib safety and efficacy data in patients with difficult-to-treat chronic lymphocytic leukaemia

AstraZeneca and its global biologics research and development arm, MedImmune, will continue the oncology momentum built during 2016 with a strong end-of-year presence at three major congresses. In total, 50 abstracts – including 15 oral presentations – have been accepted across:

• ASH: The 58th American Society of Hematology Annual Meeting, 3-6 December 2016, San Diego, USA

• WCLC: The 17th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer, 4-7 December 2016, Vienna, Austria

• SABCS: The 2016 San Antonio Breast Cancer Symposium, 6-10 December 2016, San Antonio, USA

The December congresses will offer a comprehensive update on AstraZeneca’s portfolio progress and highlight the scientific strength and clinical potential of the company’s cancer medicines – in particular Iressa, Tagrisso and Faslodex – as well as the company’s emerging presence in blood cancers.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “At the end of a memorable year for AstraZeneca in oncology, we will reinforce our leadership in lung and breast cancer research and our growing late-stage pipeline of potential medicines for life-threatening blood cancers. Our data will confirm the superiority of Tagrisso over standard of care chemotherapy in EGFR T790M mutation-positive non-small cell lung cancer and of Faslodex over Arimidex as 1st-line treatment in advanced breast cancer. New data will add to the emerging safety and efficacy profile of acalabrutinib, our potential best-in-class investigational therapy for the treatment of a range of B-cell malignancies.”

At ASH: Rapid progress in haematology research

Less than a year after announcing a majority investment in Acerta Pharma, which is becoming AstraZeneca’s haematology Centre of Excellence, the Company will demonstrate

momentum in blood cancers with new clinical data on acalabrutinib, its investigational, highly selective, potent Bruton tyrosine-kinase (BTK) inhibitor in Phase III development for B-cell malignancies. The 2016 ASH Annual Meeting will feature two oral presentations on acalabrutinib:

• Acalabrutinib monotherapy in patients with Richter transformation from the Phase I/II ACE-CL-001 clinical study (Oral presentation, Abstract #60, 3 December 2016, 08:45 PST, Room 6AB)
• Acalabrutinib monotherapy in patients with ibrutinib intolerance: results from the Phase I/II ACE-CL-001 clinical study (Oral presentation, Abstract #638, 5 December 2016, 07:15 PST, Room 5AB)

The Company will also report new pre-clinical data on a range of investigational treatment mechanisms with potential to address unmet medical needs in blood cancers.

At WCLC: Tagrisso data show clinical benefit in EGFR T790M-positive NSCLC in confirmatory Phase III trial

With 26 abstracts and nine oral presentations – including a presentation on AURA3 which will be part of the Presidential Symposium – AstraZeneca will showcase the breadth and potential of its lung cancer portfolio. Tagrisso will be a particularly strong focus, with detailed data from the positive AURA3 trial in patients with EGFR T790M mutation-positive NSCLC who have progressed after EGFR tyrosine kinase inhibitor treatment. This is the first randomised, controlled Phase III trial for Tagrisso against standard-of-care chemotherapy, and includes results from plasma ctDNA testing. Analyses will also be presented on Phase II data in patients with CNS metastases:

Randomised Phase III study of osimertinib vs platinum-pemetrexed for EGFR T790M-positive advanced NSCLC (AURA3) (Oral presentation, Abstract PL03.03, 6 December 2016, 09:05 CET, Hall D)

• Osimertinib vs platinum-pemetrexed for T790M-positive advanced NSCLC (AURA3): plasma ctDNA analysis (Mini-oral presentation, Abstract MA08.03, 6 December 2016, 11:12 CET, Lehar 3-4)

• CNS response to osimertinib in patients with T790M-positive advanced NSCLC: pooled data from two Phase II trials (Mini-oral presentation, Abstract MA16.11, 7 December 2016, 15:32 CET, Strauss 2)

Iressa presentations at WCLC include an oral ‘late breaker’ report of over 10 years experience with the US Iressa Clinical Access Program (ICAP):

Analysis of Outcomes in US IRESSA Clinical Access Program (ICAP) Patients on Gefitinib for More Than 10 Years (Oral presentation, Abstract OA23.07, 7 December 2016, 15:25 CET, Stolz 2)

In addition, data from the Phase II ATLANTIC trial of durvalumab in ≥3rd-line treatment of locally advanced or metastatic, EGFR/ALK wild type NSCLC will also be presented.

At SABCS: Phase III Faslodex data extend understanding in advanced breast cancer
Latest data from the Phase III FALCON trial to be presented at the SABCS 2016 congress will build on previous findings demonstrating superior progression-free survival (PFS) with Faslodex over Arimidex in the 1st-line treatment of women with advanced hormone receptor positive (HR+) breast cancer, including an analysis in women with and without metastases that have spread to the liver and/or lung, so-called visceral disease.

Key presentations among the 14 abstracts at SABCS include:

Progression-free survival results in patient subgroups from a Phase III randomised trial of fulvestrant 500mg vs. anastrozole for hormone receptor-positive advanced breast cancer (FALCON) (Poster presentation number: P2-08-02, Poster Session 2, 8 December 2016, 07:30-09:00 CST, Hall 1)

• Progression-free survival results in postmenopausal Asian women: subgroup analysis from a Phase III randomised trial of fulvestrant 500mg vs anastrozole for hormone receptor-positive advanced breast cancer (FALCON) (Poster presentation number: P2-08-09, Poster Session 2, 8 December 2016, 07:30-09:00 CST, Hall 1)

• A real-world evidence study to define the prevalence of endocrine therapy-naïve hormone receptor-positive locally advanced or metastatic breast cancer in the US (Poster presentation number: P5-08-20, Poster Session 5, 9 December 2016, 17:00-19:00 CST, Hall 1)

– ENDS –

NOTES TO EDITORS

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 AstraZeneca and Acerta Pharma

AstraZeneca acquired a majority stake interest in Acerta Pharma and its core asset, acalabutinib in February 2016. Acerta Pharma serves as AstraZeneca’s haematology Centre of Excellence and the Acerta employees provide substantial and valuable expertise in blood cancers.

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.