Merck and Co Inc (MRK)

[DewDiligence]

Keytruda phase-3 results in first-line gastric cancer: i) Monotherapy was non-inferior, but not superior to standard chemo for OS in patients with PD-L1>=1%; ii) Addition of Keytruda to standard chemo did not provide a statsig benefit in either PFS or OS in the prespecified subgroups.

https://finance.yahoo.com/news/merck-provides-phase-3-keynote-211900691.html

These data are from the KEYNOTE-062 study (https://clinicaltrials.gov/ct2/show/NCT02494583 ).

Keytruda monotherapy received FDA accelerated approval in third-line gastric cancer in Sep 2017 based on a single-arm study (#msg-134837349), but it failed to show a statsig benefit vs Taxol in second-line gastric cancer. KEYNOTE-062 is the first pivotal trial in the first-line setting.