Merck, Eisai end two Keytruda combination trials after missing main goals

Merck (NYSE:MRK) and Eisai (OTCPK:ESALF) (OTCPK:ESAIY) announced Friday that the companies would halt two late-stage combination trials for cancer therapy Keytruda in melanoma and colorectal cancer after the studies fell short of main goals.

The trials known as LEAP-003 and LEAP-017 were designed to evaluate the anti-PD-1 therapy plus Eisai’s (OTCPK:ESALF) tyrosine kinase inhibitor Lenvima in certain adults with melanoma and colorectal cancer as a first-line and second-line option, respectively.

The decision comes after a review of an interim analysis by an independent Data Monitoring Committee.

The panel determined that LEAP-003 did not improve overall survival (OS), one of the study’s dual primary endpoints, versus Keytruda alone, and LEAP-017 didn’t meet the primary endpoint, OS versus regorafenib or TAS-102.

However, an earlier analysis of LEAP-003 indicated that Keytruda and Lenvima met the trial’s other dual primary endpoint, progression-free survival (PFS) with a statistically significant improvement compared to Keytruda plus placebo.

LEAP-017 showed improvements in key secondary endpoints of PFS, objective response rate (ORR) and duration of response (DOR) without statistical significance.

Both studies did not indicate new safety signals for the therapeutic combination, already approved in countries like the U.S. and Japan for advanced renal cell carcinoma (RCC) and certain types of advanced endometrial carcinoma.

Read: Citing market trends, Seeking Alpha contributor SM Investor argues that Merck (MRK) will continue to grow sales of Keytruda and its HPV vaccine Gardasil in the years ahead.