AstraZeneca : to update on leading lung cancer portfolio at WCLC 2015

Data will be reported from across AstraZeneca's industry-leading lung cancer portfolio at the World Conference on Lung Cancer (WCLC) 2015, beginning this weekend in Denver, Colorado. Presentations will feature 25 abstracts (including 9 oral and 4 late breaker presentations) on the company's lung cancer pipeline, designed to address the unmet needs of patients with different forms of lung cancer.

AZD9291 will be the focus of six oral presentations on its clinical activity in both first-line and previously-treated patients with epidermal growth factor receptor mutation (EGFRm) T790M advanced non-small cell lung cancer (NSCLC). The data are consistent with previously reported efficacy and safety results of AZD9291 in these treatment settings.

Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca said: "The data presented at WCLC illustrate the breadth of our lung cancer research across multiple disease settings and lines of therapy, as we aim to develop a comprehensive portfolio of effective and durable treatments for patients. AZD9291 is moving through clinical development with unprecedented speed, and was recently granted US Priority Review designation in recognition of its potential to target the mutation that drives resistance to current treatments for EGFR mutation positive advanced non-small cell lung cancer in the majority of patients."

In addition to AZD9291, AstraZeneca will also present results from the IRESSA® (gefitinib) Clinical Access Programme (ICAP), which provides data on the long-term safety and tolerability of the EGFR tyrosine kinase inhibitor in 188 US cancer patients outside the clinical trial setting. IRESSA® was approved by the US Food and Drug Administration (FDA) as a first-line treatment for EGFRm metastatic NSCLC in July 2015, and is already available in 91 countries worldwide.

Immuno-oncology (IO): Update on key clinical trials

Trial designs for the ongoing IO late-stage studies that will be presented at WCLC include:

• ATLANTIC (NCT02087423): A Phase II trial of durvalumab (PD-L1 mAb) as third-line treatment in patients with PD-L1 positive, locally advanced or metastatic NSCLC
• ARCTIC (NCT 02352948): A Phase III trial of durvalumab monotherapy and in combination with tremelimumab (CTLA-4 mAb) versus standard of care in third-line metastatic NSCLC
• PACIFIC (NCT02125461): A Phase III placebo-controlled trial of durvalumab compared to placebo in patients with locally advanced, unresectable, NSCLC following completion of treatment with chemoradiotherapy and no evidence of tumour progression.

Robert Iannone, Head of Immuno-Oncology, Global Medicines Development, at AstraZeneca said: "WCLC provides another opportunity for us to update the medical community on our extensive immuno-oncology development programme in lung cancer. We have made tremendous progress in developing immuno-oncology-based combination approaches, with nine pivotal studies planned or underway in NSCLC alone, which will provide us with a steady stream of research milestones in the coming months."

The FDA has granted Fast Track designation to tremelimumab for the treatment of mesothelioma, an aggressive, rare form of cancer that affects the lining of the lungs and abdomen. Durvalumab was also granted Fast Track designation for patients with advanced NSCLC, who have received at least two prior systemic-treatment regimens, who do not have EGFR mutations or anaplastic lymphoma kinase (ALK) alterations, and have tumours that are determined to be PD-L1 positive.

Data presented at WCLC are part of AstraZeneca's rapidly advancing lung cancer programme, which includes the following pivotal clinical trials and upcoming milestones.

1 Osimertinib has recently been published by the World Health Organization (WHO) as the proposed International Nonproprietary Name (INN) for AZD9291, and may become formally adopted by November 2015.

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 - lung, ovarian, 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.

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

UK

US

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal

distributed by