AstraZeneca updates on immuno-oncology combinations development programme at the 2015 ASCO Annual Meeting

Tuesday, 2 June 2015

AstraZeneca and MedImmune, the Company’s global biologics research and development arm, provided an update on the progress of their combination-focused immuno-oncology pipeline at an investor science event at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on 1 June 2015.

Commenting on the Company’s immuno-oncology combination data presented at the 2016 ASCO Annual Meeting, Chief Executive Officer, Pascal Soriot, said: “Immuno-oncology has continued to take centre stage at the 2016 ASCO Annual Meeting this year, as we see more evidence of the significance of this approach for patients. At AstraZeneca we have been clear in our belief that combinations hold the key to transforming clinical practice for the patients not benefiting from the currently-available immunotherapies. The data presented on the combination of MEDI4736 and tremelimumab are truly exciting. As the frontrunner combination of two immuno-oncology molecules in non-small cell lung cancer, it is demonstrating promising clinical activity, in particular in the majority of patients who have low or no PD-L1 expression. With our longstanding expertise in developing highly effective small molecule medicines, including Lynparza and AZD9291, we are now also seeing the potential of combining these targeted medicines with immuno-oncology molecules to deliver efficacious and durable treatment to patients.”

Highlights of the update were:

• Data presented on MEDI4736, the Company’s anti-PD-L1 monoclonal antibody, as monotherapy in heavily pre-treated patients with non-small cell lung cancer (NSCLC) are encouraging and suggest that patients with PD-L1 positive tumours may have an improved overall response rate compared to patients with PD-L1 negative tumours, highlighting the unmet medical need for the majority of tumours that are PD-L1 negative.

• MEDI4736 is demonstrating strong potential to combine with both immunotherapy and small molecules; AstraZeneca and MedImmune have an extensive development programme underway across multiple tumour types and stages of disease, assessing the potential for immunotherapy to either replace or combine with traditional chemotherapy.

Immuno-oncology combinations

• The combination of MEDI4736 and tremelimumab (anti-CTLA-4 monoclonal antibody) is demonstrating efficacy regardless of PD-L1 status, showing particular promise for the significant number of patients who fail to respond to anti-PD-1/PD-L1 monotherapy because of their PD-L1 biomarker negative status.

• The combination of MEDI4736 and tremelimumab is also showing a manageable safety profile, with a discontinuation rate due to related adverse events of only 7%.

• Nine immuno-oncology clinical trials are planned and underway in NSCLC across early (adjuvant and unresectable stage III) and advanced stages of the disease, including three new studies in first-line metastatic NSCLC announced at the 2016 ASCO Annual Meeting, assessing MEDI4736 in combination with tremelimumab or with chemotherapy.

• AstraZeneca is exploring the potential clinical benefit of the combination of MEDI4736 and tremelimumab in additional tumour types including squamous cell carcinoma of the head and neck (SCCHN), and announced new tumour types, including gastric, pancreatic and bladder cancer, with the aim of changing the treatment paradigm for patients with a chemotherapy-free regimen.

• Other immuno-oncology combinations are being explored with the Company’s three OX40 molecules in advanced solid and haematological malignancies, with the optimal potential medicine to be selected by the end of 2015.

Immuno-oncology and small molecule combinations

• The combination of targeted therapy and immune checkpoint inhibitors has the potential to offer higher response rates and extended duration of responses.

• MEDI4736 has been shown to be well tolerated in combination at full dose with multiple tyrosine kinase inhibitors (TKIs), with encouraging preliminary efficacy data, includingMEDI4736 and BRAF and MEK inhibitors - early data shows encouraging confirmed partial response (69%) and disease control rate (100%).

• MEDI4736 and AZD9291 - early data indicates the molecules are well tolerated in combination at their Phase III doses, providing early promise of a potential new standard of care in EGFR mutation (EGFRm) and T790M positive NSCLC. EGFR remains one of the major tumour drivers despite progression on EGFR TKIs.

•  MEDI4736 and Iressa – early data in EGFRm TKI-naïve NSCLC shows a 64% (9/14) partial response rate. The combination is planned for Phase III study in first line EGFRm NSCLC.

• In addition, combination trials of MEDI4736 and Lynparza are planned to start by the third quarter in 2015.

Audio replay and the presentation from the analyst and investor science event will be available on the investor pages of the AstraZeneca website here.

NOTES FOR EDITORS

About AstraZeneca in Oncology

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 investigational medicines is focused on four main disease areas - ovarian, lung, 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.

About MedImmune

MedImmune is the worldwide biologics research and development arm of AstraZeneca. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres. For more information, please visit www.medimmune.com.

About AstraZeneca

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

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