Eli Lilly and Co. and Merck have extended an existing collaboration to evaluate the safety and efficacy of the combination of Lilly’s ALIMTA (pemetrexed for injection) and Merck’s KEYTRUDA (pembrolizumab) in a Phase III study in first-line nonsquamous non-small cell lung cancer (NSCLC). The study will be sponsored by Merck and will be open to patients with NSCLC in the first-line setting, regardless of PD-L1 status. Financial details were not disclosed.

The expansion of this oncology trial collaboration follows encouraging data from a Phase I study, which evaluated pemetrexed, carboplatin and pembrolizumab in first-line nonsquamous NSCLC. 

Pemetrexed is a leading therapeutic option used in combination with platinum-based therapies in this setting, making it an ideal candidate for combination studies with immunotherapy treatments.  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, and is currently approved as a single-agent therapy for certain types of NSCLC.

“The extension of our immuno-oncology collaboration with Merck reinforces our combination-focused strategy, which we believe has the potential to help this patient population where there is a significant unmet need,” said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. “Building upon this scientific partnership represents our shared, strong commitment to improve the lives of those living with cancer.”

“Based on the data for ALIMTA, we believe this collaboration with Lilly has great potential to help even more patients,” said Roger Dansey, M.D., therapeutic area head and senior vice president, oncology late stage development, Merck Research Laboratories. “We look forward to continuing our collaboration with Lilly across all of these trials – including the registrational Phase III all-comers trial for NSCLC.”