Eli Lilly and Merck announced a new immuno-oncology partnership in which they will initiate a Phase 1 study across multiple tumor types to evaluate Lilly’s cyclin-dependent kinase (CDK) 4 & 6 inhibitor abemaciclib (LY2835219) and Merck’s KEYTRUDA (pembrolizumab).
According to a press release, after the Phase 1 trial, both companies will decide if there is enough potential to continue to Phase 2 trials in patients diagnosed with metastatic breast cancer or non-small cell lung cancer (NSCLC). Lilly will sponsor the Phase 1 clinical trial and further subsequent Phase 2 studies. Enrollment is available from early 2016 and financial details have not been disclosed yet.
“With our active Phase III program underway for abemaciclib in both metastatic breast cancer and non-small cell lung cancer, we are committed to uncovering every opportunity to help these patients – and this includes exploring abemaciclib in combination with immunotherapy,” explained Senior Vice President, Product Development and Medical Affairs for Lilly Oncology, Richard Gaynor, M.D. “We’re encouraged by our productive immuno-oncology collaborations with Merck, through its affiliates, and coming together for another clinical trial is a natural evolution of our scientific collaboration.”
Abemaciclib is an inhibitor of the cell cycle, designed to block cancer cells growth by targeting CDK4 and CDK6. Cyclin-dependent kinases (CDK) play an important role in stabilizing cell cycle progression, which is what controls cell growth. Results from previous preclinical trials and early-stage clinical studies have positively backed the evaluation of abemaciclib to treat human cancers, including breast and lung cancer, in which CDK 4 and CDK 6 paths trigger cancer cell growth.
Pemobrolizumab is a humanized monoclonal antibody that increases the body’s immune system’s ability to detect and fight tumor cells. Pemobrolizumab prevents PD-1 and its ligands (PD-L1 and PD-L2) from interacting, thus activating T lymphocytes. This process may affect cancer and healthy cells.
“We look forward to continuing our collaboration with Lilly on this combination study with KEYTRUDA and abemaciclib,” commented Vice President and Therapeutic Area Head, Oncology Early-Stage Development at Merck Research Laboratories, Eric Rubin, M.D. “Strategic collaborations such as this one reinforce the commitment we have to bringing new combination treatments to the forefront for people with cancer.”