Merck and Bristol-Myers Squibb continue to their race in immuno-oncology, a popular research area.
On Monday, Merck announced that it will apply for approval of its melanoma drug, Keytruda, for treatment of lung cancer, in the first half of 2015. The company intends to files its first-in-class cancer immunotherapy specifically for treatment of non-small cell lung cancer (NSCLC) patients without ALK or EGFR mutations.
Approval of Keytruda for lung cancer would provide the company with a significantly larger commercial opportunity, with more than 220,000 new cases of lung cancer diagnosed in the US each year, compared with roughly 76,000 new cases for melanoma, according to the American Cancer Society (ACS).
Merck’s announcement followed Bristol-Myers Squibb’s (BMS) press release announcing positive late-stage results for its immuno-oncology drug nivolumab, approved last month as Opdivo. BMS said that its Phase III study evaluating Opdivo versus docetaxel in previously treated patients with advanced, squamous cell NSCLC was stopped early because an independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, with Opdivo demonstrating superior overall survival (OS). The company is now inviting patients in the docetaxel group to opt into Opdivo through an open-label extension study.
Both Merck and BMS drugs are in a subset of immuno-oncology drugs called checkpoint inhibitors. The drugs are PD-1 inhibitors. PD-1 is a molecular brake that prevents the immune system from seeing tumors as invaders and enables cancer to avoid attack.
In addition to Merck and BMS, Roche and AstraZeneca are also working on immuno-oncology drugs. Roche said it expects data for its PD-L1 drug in lung and bladder cancer in the first half of 2015, with potential filings seeking approval in the second half, depending on the results of the trials.
Sources: Merck; Bristol-Myers Squibb