Merck’s PhIII liver cancer study for Keytruda fails on two key endpoints, just three months after the FDA gave it the green light

In a rare setback, Merck has suffered a key Phase III failure for Keytruda that could put a crimp in its sales prospects.

Roy Baynes

The pharma giant reported after the market closed on Tuesday that Keytruda failed the KEYNOTE-240 study for hepatocellular carcinoma, the most common type of liver cancer. The trial missed on both overall survival as well as progression-free survival. That news arrived just 3 months after the FDA offered an accelerated approval on liver cancer based on their earlier mid-stage data for the drug. 

Staying on the market requires Merck to put up positive pivotal data. Questions about the drug’s future in liver cancer dinged Merck’s stock $MRK, which dropped slightly more than 1% after the release hit.

Merck was quick to note that it’s studying Keytruda in a range of other liver cancer studies, but the advantage here has clearly switched to Opdivo for now, which has been dragging steadily behind Keytruda after falling short on lung cancer, where Merck holds first-line advantage.

This wasn’t the only confirmatory Phase III study to flop. Just weeks ago Eli Lilly had to suspend marketing of Lartruvo after its pivotal for soft tissue sarcoma failed. These back-to-back setbacks, though, are unlikely to slow down the FDA, which has proved eager to hand out accelerated OKs — particularly for cancer drugs — in recent years.

“While we are disappointed KEYNOTE-240 did not meet its co-primary endpoints, the results for overall survival, progression-free survival and objective response rate are generally consistent with findings from the Phase II study, KEYNOTE-224, which led to the accelerated approval of KEYTRUDA for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Photo credit: AP Images.

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 51,200+ biopharma pros who read Endpoints News by email every day.

Free Subscription

VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Associate Director CMC
Elektroki Boston, MA
Director Process Development
Elektroki Boston, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

Visit Endpoints Careers ->