AstraZeneca and Lilly to collaborate on Immuno-oncology combination clinical trial in solid tumours

AstraZenecaAstraZeneca and Eli Lilly and Company (Lilly) today announced that they have entered into a clinical trial collaboration to evaluate the safety and preliminary efficacy of AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with ramucirumab (CYRAMZA®), Lilly's VEGF Receptor 2 antiangiogenic cancer medicine. The planned study will assess the combination as a treatment for patients with advanced solid tumours.

The Phase I study is expected to establish the safety and a recommended dosing regimen, with the potential to open expansion cohorts in various tumours of interest, for the combination of MEDI4736 and ramucirumab. Under the terms of the agreement, the trial will be sponsored by Lilly. Additional details of the collaboration, including tumour types to be studied and financial terms, were not disclosed.

MEDI4736 is a monoclonal antibody developed by MedImmune, AstraZeneca’s global biologics research and development arm, directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. Ramucirumab is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. Preclinical data indicate that combining VEGFR inhibitors with immune checkpoint blockades, such as PD-L1 targeted agents, has the potential to enhance anti-tumour activity.

Robert Iannone, Head of Immuno-oncology, Global Medicines Development at AstraZeneca, said: "We believe that combination therapy in immuno-oncology has the potential to transform the way cancer is treated. MEDI4736 is supported by a comprehensive development programme and is emerging as a cornerstone of our combination-focused immuno-oncology pipeline targeting multiple tumour types. Our collaboration with Lilly is a great addition to our programme and provides the opportunity to explore another exciting, novel combination that could deliver important clinical benefit to cancer patients."

"The development of immune checkpoint inhibitors has been one of the more exciting research advancements in recent oncology history, but it is going to be even more interesting to see how these inhibitors can be combined with other proven targeted therapies," said Richard Gaynor, M.D., senior vice president, product development and medical affairs, Lilly Oncology. "This collaboration represents the next wave of immuno-oncology research by bringing together two innovative medicines - Lilly's CYRAMZA and AstraZeneca's MEDI4736 - as a novel combination that we hope will one day provide new cancer treatment solutions."

About Ramucirumab (CYRAMZA®)
In the EU, ramucirumab has been granted marketing authorisation for use in adults, in combination with paclitaxel, for the treatment of advanced gastric or gastro-oesophageal junction adenocarcinoma following prior chemotherapy, and as a monotherapy in this setting for patients for whom treatment in combination with paclitaxel is not appropriate.

Ramucirumab is approved in the U.S. for use as a single agent or in combination with paclitaxel as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. It is also approved in the U.S. in combination with docetaxel as a treatment for people with metastatic non-small cell lung cancer (NSCLC) whose cancer has progressed on or after platinum-based chemotherapy. Additionally, it is approved in the U.S. with FOLFIRI as a treatment for people with metastatic colorectal cancer (mCRC) whose cancer has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

There are several additional studies underway or planned to investigate ramucirumab as a single agent and in combination with other anti-cancer therapies for the treatment of multiple tumour types.

Ramucirumab is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. Ramucirumab inhibited angiogenesis in an in vivo animal model.

CYRAMZA is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

About MEDI4736
MEDI4736 is an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour's immune-evading tactics.

MEDI4736 was accelerated into Phase III clinical development in non-small cell lung cancer and head and neck cancer. The OCEANS clinical development programme will evaluate MEDI4736 as monotherapy and in combination with a CTLA-4 (tremelimumab) in lung cancer, across the spectrum of the disease. In head and neck cancer, MEDI4736 is being investigated both as monotherapy and in combination with tremelimumab, looking at patients with different PD-L1 expression status who have failed on chemotherapy.

A comprehensive development programme for MEDI4736 is underway across multiple tumour types, stages of disease, lines of therapy, and in combination with both immuno-oncology compounds as well as small molecules.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

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.

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