Eli Lilly has formed two separate collaboration agreements. The first agreement with Merck is an oncology clinical trial collaboration to evaluate the safety, tolerability and efficacy of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Lilly compounds in multiple clinical trials. The second, with Bristol-Myers Squibb, is a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of BMS' immunotherapy Opdivo (nivolumab) in combination with Lilly's galunisertib (LY2157299).
Merck will conduct a phase II study examining the combination of pembrolizumab with pemetrexed in first-line non-squamous, non-small cell lung cancer (NSCLC). This study currently is enrolling. Lilly will conduct a multiple-arm phase I/II study examining the combination of ramucirumab with pembrolizumab in multiple tumors. This study is anticipated to begin in 2015. Lilly also will conduct a phase I/II study examining the combination of necitumumab with pembrolizumab in NSCLC. This study is anticipated to begin in 2015.
The agreement is between Lilly and Merck, through a subsidiary. Additional details of the collaboration have not been disclosed.
“Cancer is not one disease but rather more than 200 diseases, all of which have different causes and treatments,” said Richard Gaynor, M.D., senior vice president, product development and medical affairs, Lilly Oncology. “Therefore research into combinations of immune-based therapies with other agents that could address these different tumor types is important. This collaboration between Lilly and Merck represents each company’s strong commitment to patients fighting these devastating diseases.”
The collaboration with BMS is a phase I/II trial to evaluate the investigational combination of Opdivoand galunisertib as a potential treatment option for patients with advanced (metastatic and/or unresectable) glioblastoma, hepatocellular carcinoma and non-small cell lung cancer.
Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T-cells. Galunisertib is a TGF beta R1 kinase inhibitor that in vitroselectively blocks TGF beta signaling. TGF beta promotes tumor growth, suppresses the immune system and increases the ability of tumors to spread in the body. This collaboration will address the hypothesis that co-inhibition of PD-1 and TGF beta negative signals may lead to enhanced anti-tumor immune responses than inhibition of either pathway alone.
"Combination therapies will be key to addressing tumor heterogeneity and the inevitable resistance that is likely to develop to even the most promising new tailored therapies," said Gaynor. "To that end, having multiple cancer pathways and technology platforms will be critical in an era of combinations to ensure sustainability beyond any single asset."
The study will be conducted by Lilly. Additional details of the collaboration have not been disclosed.