Eli Lilly and Co. and Merck have entered another immuno-oncology collaboration to evaluate abemaciclib (LY2835219), Lilly's cyclin-dependent kinase (CDK) 4 and 6 inhibitor, and Merck's KEYTRUDA (pembrolizumab) in a Phase I study across multiple tumor types. Promising Phase I results offer the potential to progress to Phase II trials in metastatic breast cancer or non-small cell lung cancer (NSCLC). Lilly is sponsoring the Phase I study, and any subsequent Phase II studies. Enrollment is scheduled to begin in early 2016. Financial details were not disclosed.

Lilly's abemaciclib is designed to block the growth of cancer cells by specifically inhibiting CDK4 and CDK6. Pembrolizumab is a humanized monoclonal antibody that works by increasing the ability of the body's immune system to help detect and fight tumor cells. Pembrolizumab blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.

"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," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "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."

"We look forward to continuing our collaboration with Lilly on this combination study with KEYTRUDA and abemaciclib," said Eric Rubin, M.D., vice president and therapeutic area head, oncology early-stage development, Merck Research Laboratories. "Strategic collaborations such as this one reinforce the commitment we have to bringing new combination treatments to the forefront for people with cancer."