One of Merck’s pivotal stomach cancer trials for Keytruda flops, just months after an FDA OK

Less than three months after Merck $MRK won an accelerated OK to market Keytruda as a third-line drug for stomach cancer, the pharma giant says their checkpoint failed to produce either positive overall survival data or progression-free survival results for the same indication in a second-line setting.

The pivotal Phase III flop for advanced gastric or gastroesophageal junction adenocarcinoma marks the latest in a long string of often surprising hits and misses in the checkpoint field.

Roy Baynes

For Merck, which has hundreds of trials running around Keytruda, the focus now shifts to KEYNOTE-062, a Phase III clinical trial studying Keytruda as a monotherapy or in combination with chemotherapy as first-line treatment for patients with PD-L1 positive advanced gastric or gastroesophageal junction cancer. There is also KEYNOTE-585, a Phase III trial studying Keytruda (pembrolizumab) in combination with chemotherapy in a neoadjuvant/adjuvant setting.

Merck has been steadily gaining market ground on Bristol-Myers Squibb $BMY, the leader in checkpoints, after a string of successful trials for lung cancer. Bristol-Myers Squibb also has third-line approval for Opdivo in gastric cancer, in indication which just days ago defeated a Phase III mounted by Bavencio from Pfizer and Merck KGaA. Bavencio was tested against chemo rather than a placebo.

“We remain committed to the continued study of Keytruda for gastric cancers and finding new options for patients facing this difficult-to-treat cancer type across various treatment settings,” said Roy Baynes, chief medical officer at Merck Research Laboratories, in a statement.


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

Comprehensive daily news report for those who discover, develop, and market drugs. Join 41,700+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Head of Business Development
Wren Therapeutics Boston, MA
Life Sciences Venture Professional
Northpond Ventures Washington, DC
Senior Drug Discovery Oncologist
Schrödinger New York, NY

Visit Endpoints Careers ->