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.
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.