Eli Lilly Enters into Collaborations for Cancer Treatments

On Jan. 13 2015, Eli Lilly announced two clinical trial collaborations to evaluate the safety and efficacy of combination therapies for the treatment of cancer. "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 Richard Gaynor, MD, senior vice-president, product development and medical affairs, Lilly Oncology, in a press release. "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 first collaboration, with Bristol-Myers Squibb (BMS), will test BMS’s immunotherapy Opdivo (nivolumab) in combination with Lilly's galunisertib (LY2157299). The Phase I/II trial will be conducted by Lilly and “will evaluate the investigational combination of Opdivo and galunisertib as a potential treatment option for patients with advanced (metastatic and/or unresectable) glioblastoma, hepatocellular carcinoma, and non-small cell lung cancer.”

According to Lilly, 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 vitro selectively blocks TGF beta signaling. TGF beta promotes tumor growth, suppresses the immune system and increases the ability of tumors to spread in the body.” The collaboration will test 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.

"Advanced solid tumors represent a serious unmet medical need among patients with cancer," said Michael Giordano, senior vice-president, head of development, oncology, Bristol-Myers Squibb, in a press release. "Our clinical collaboration with Lilly underscores Bristol-Myers Squibb's continued commitment to explore combination regimens from our immuno-oncology portfolio with other mechanisms of action that may accelerate the development of new treatment options for patients."

In the second collaboration, Lilly and Merck, known as MSD outside the US and Canada, will conduct oncology clinical trials to evaluate the safety, tolerability, and efficacy of Merck's anti-PD-1 therapy KEYTRUDA (pembrolizumab) in combination with Lilly compounds in multiple clinical trials. The trials include a Phase II study, to be conducted by Merck, that will examine the combination of pembrolizumab with pemetrexed in first-line non-squamous, non-small cell lung cancer (NSCLC).

In a study to begin in 2015, Lilly will conduct a multiple-arm Phase I/II study examining the combination of ramucirumab with pembrolizumab in multiple tumors. Also to begin in 2015, a Phase I/II study will examine the combination of necitumumab with pembrolizumab in NSCLC.

"Cancer is not one disease but rather more than 200 diseases, all of which have different causes and treatments," said Richard Gaynor, MD, senior vice-president, product development and medical affairs, Lilly Oncology, in a press release. "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."

"Our understanding of the immune system's role and its impact in the treatment of cancer continues to grow," said Eric Rubin, MD, vice-president, global clinical development, oncology, Merck Research Laboratories, in the release. "Collaborations such as this one are important in advancing the investigation of novel immuno-oncology combinations in different cancers, and to achieving our shared goal of bringing meaningful benefits to patients facing cancer."

Sources:
Eli LillyBMS