Lilly and Merck move on with oncology clinical trial of and Keytruda

Eli Lilly and Merck are moving on with an existing oncology clinical trial collaboration to evaluate the safety and efficacy of the combination of Lilly’s Almita (pemetrexed for injection) and Merck’s Keytruda (pembrolizumab) in a pivotal Phase III study in first-line nonsquamous non-small cell lung cancer (NSCLC).

Image: Lilly

The two companies, known as MSD outside the United States and Canada said Wednesday that the study, which will be sponsored by Merck, will be open to patients with NSCLC in the first-line setting, regardless of PD-L1 status. Financial details of the collaboration were not disclosed.

The expansion of the  collaboration comes following the release of encouraging data from a Phase I study, presented earlier this year, the companies have said.

Pemetrexed is used in combination with platinum-based therapies in this setting 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. 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 – and is currently approved as a single-agent therapy for certain types of NSCLC.

Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology said: “Building upon this scientific partnership represents our shared, strong commitment to improve the lives of those living with cancer.”

Roger Dansey, M.D., therapeutic area head and senior vice president, oncology late stage development, Merck Research Laboratories, said that the collaboration with Lilly has great potential to help more patients.

In addition to the studies of pemetrexed and pembrolizumab in first-line nonsquamous NSCLC, other ongoing trials from the original agreement between Lilly and Merck, through a subsidiary, include A Phase I/II study examining the combination of ramucirumab with pembrolizumab in multiple tumors, and A Phase I/II study examining the combination of necitumumab with pembrolizumab in NSCLC.