AstraZeneca delivers new data on expanding portfolio of cancer medicines at 2017 American Society of Clinical Oncology (ASCO) Annual Meeting

Lynparza’s potential in BRCA-mutated metastatic breast cancer to be highlighted in plenary presentation of Phase III OlympiAD trial

Key trials show further evidence of Tagrisso efficacy in patients with EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) and central nervous system (CNS) metastases (AURA3 trial) or leptomeningeal disease (BLOOM trial)

New data demonstrate advances in Immuno-Oncology, including Imfinzi in non-small cell lung and bladder cancer

 AstraZeneca, along with its global biologics research and development arm, MedImmune, will demonstrate how it is rapidly delivering on the Company’s science-led strategy for transformational cancer medicine development at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US, 2-6 June 2017.

With three new oncology medicines addressing the unmet needs of patients with ovarian, lung, and bladder cancers approved in under three years, AstraZeneca is now halfway to delivering on its promise to launch six new medicines for cancer by 2020.

This progress is reflected in the 100 company-sponsored and supported abstracts, including five Best-of-ASCO presentations, 11 oral presentations and eight poster discussions, accepted for the meeting. These include new data on approved and potential new medicines from the Company’s pipeline across multiple scientific platforms and tumour types.

Jamie Freedman, Executive Vice President, Oncology at AstraZeneca, said: “2017 is a pivotal year for our oncology portfolio as global launch and development programmes for Lynparza, Tagrisso and Imfinzi gain momentum, with further pivotal data anticipated in the coming months, in particular in 1st-line non-small cell lung cancer. We are excited to demonstrate the strength of our rapidly-expanding portfolio at ASCO, including the positive OlympiAD results for Lynparza in BRCA-mutated metastatic breast cancer.”

Growing confidence in DNA Damage Response (DDR) approach emphasised by OlympiAD results

‘Late-breaker’ data from the OlympiAD trial of Lynparza (olaparib) versus chemotherapy in BRCA-mutated metastatic breast cancer (Abstract #LBA4) are the first positive Phase III results for a poly ADP-ribose polymerase (PARP) inhibitor beyond ovarian cancer. They are an important next step in the development of AstraZeneca’s DDR approach to selectively targeting of tumours through deficiencies in cancer cell DNA repair mechanisms.

Additional Lynparzadata will include:

• SOLO-2: Oral presentation of Phase III data on the relationship between health-related quality of life (HRQOL) and patient-centred and clinical outcomes with Lynparzamaintenance following chemotherapy in patients with BRCA-mutated platinum-sensitive relapsed serous ovarian cancer (Abstract #5507)
• Study 19: Randomised Phase II overall survival and updated progression-free survival data for the combination of Lynparzaand cediranib versus Lynparzaalone in recurrent platinum-sensitive ovarian cancer (Abstract #5535)

AstraZeneca’s unique DDR pipeline will also be illustrated through an oral presentation of Phase I data on the WEE1 inhibitor, AZD1775, in combination with radiation therapy and temozolomide in patients with newly-diagnosed glioblastoma multiforme (GBM) and evaluation of intratumoural drug distribution in patients with recurrent GBM (Abstract #2005). Additional information will also be presented from a Phase I trial of AZD1775 in combination with neoadjuvant weekly cisplatin and docetaxel in borderline-resectable head and neck squamous cell carcinoma (HNSCC) (Abstract #6034).

Extended evidence of the effect of Tagrisso (osimertinib) on CNS metastases

Latest Tagrisso data from the AURA3 trial to be released during an oral presentation will provide further evidence of the response to treatment in patients with epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) and CNS metastases (Abstract#9005).

Further insights into the ability of Tagrisso to cross the blood-brain barrier will be provided through updated results from the BLOOM trial of Tagrisso in patients with EGFR mutation-positive NSCLC and leptomeningeal disease (Abstract #2020).

New data on Imfinzi (durvalumab) as monotherapy and in combination

Building on exciting recent milestones for its Immuno-Oncology programme, AstraZeneca will be presenting updated data from the NSCLC and bladder cancer cohorts of the Phase I/II Study 1108 of durvalumab in patients with advanced solid tumours. New data in locally-advanced or metastatic urothelial carcinoma (mUC) (Abstract #4525) reinforce the May 2017 US FDA approval of Imfinzifor the treatment of patients with locally advanced or mUC who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

Updated durvalumab monotherapy Study 1108 results in Stage IIIB/IV NSCLC (Abstract #9085) will also be presented. These data underline AstraZeneca’s forward momentum in lung cancer following the positive top-line results of the Phase III PACIFIC trial of durvalumab as sequential treatment in patients with locally-advanced, unresectable (Stage III) NSCLC. In an oral presentation, MedImmune will present data on a novel relationship in NSCLC between EGFR pathway activation and the immunosuppressive molecule CD73 (Abstract #11505).

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NOTES TO EDITORS

AstraZeneca/MedImmune key presentations at the 2017 ASCO Annual Meeting

Tumour Drivers & Resistance

Immuno-Oncology

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 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.