Merck & Co and Bristol-Myers Squibb have signed separate onco-immunology focused trial agreements with Eli Lilly to assess combinations of their rival PD-1 inhibitors with the latter’s cancer drugs.
The Merck alliance will test the safety, tolerability and efficacy of combining its flagship immunotherapy Keytruda (pembrolizumab) with Lilly compounds across multiple clinical trials.
Under the terms of the agreement, Merck will conduct a Phase II study assessing a mix of Keytruda and Lilly’s Alimta (pemetrexed) in first-line non-squamous, non-small cell lung cancer (NSCLC), which is currently enrolling.
Lilly will carry out a multiple-arm Phase I/II study looking at Cyramza (ramucirumab)/Keytruda in multiple tumours, as well a Phase I/II study of necitumumab/Keytruda in NSCLC, both of which are scheduled to begin this year.
Further terms were not disclosed.
The B-MS deal will see a combination of its immunotherapy Opdivo (nivolmab) and Lilly’s investigational drug galunisertib (LY2157299) put through clinical trials to test potential in advanced glioblastoma, hepatocellular carcinoma and NSCLC.
The study will be conducted by Lilly. Additional details were not disclosed.
Galunisertib is currently being assessed by B-MS as an oral treatment for advanced/metastatic malignancies, including Phase II evaluation in hepatocellular carcinoma, myelodysplastic syndromes (MDS), glioblastoma, and pancreatic cancer.
Both Keytruda and Opdivo are approved in the US for advanced melanoma, and both are now racing to bag approval for patients with NSCLC. Merck announced Sunday that it intends to file Keytruda for the treatment of NSCLC patients without ALK or EGFR mutations by mid-2015, while B-MS unveiled ueber-promising late-stage data for Opdivo showing a significant survival benefit in patients with advanced, squamous forms of the disease.