Lilly and AstraZeneca to Collaborate on Immuno-Oncology Combination Clinical Trial in Solid Tumors

Eli Lilly and Company (NYSE: LLY) and AstraZeneca (NYSE: AZN) today announced that they have entered into a clinical trial collaboration to evaluate safety and preliminary efficacy of their products.

PRESS RELEASE

INDIANAPOLIS

,

May 29, 2015

/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and

AstraZeneca

(NYSE: AZN) 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 CYRAMZA® (ramucirumab), Lilly's VEGF Receptor 2 antiangiogenic cancer medicine. The planned study will assess the combination as a treatment for patients with advanced solid tumors.

The Phase I study is expected to establish the safety and a recommended dosing regimen - with the potential to open expansion cohorts in various tumors 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 tumors 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 tumors 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 has the potential to enhance anti-tumor activity.

"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."

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 program and is emerging as a cornerstone of our combination-focused immuno-oncology pipeline targeting multiple tumor types. Our collaboration with Lilly is a great addition to our program and provides the opportunity to explore another exciting, novel combination that could deliver important clinical benefit to cancer patients."

NOTES TO EDITORS

About CYRAMZA® (ramucirumab)

In the U.S., CYRAMZA (ramucirumab) is approved for use as a single agent or in combination with paclitaxel (a type of chemotherapy) 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 combination with docetaxel (a type of chemotherapy) 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 with FOLFIRI (a type of chemotherapy) 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 CYRAMZA as a single agent and in combination with other anti-cancer therapies for the treatment of multiple tumor types.

CYRAMZA 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. CYRAMZA inhibited angiogenesis in an in vivo animal model.