Keytruda alone delays endometrial-cancer progression, but survival benefit remains unproven

Merck ($MRK) presented the first detailed Phase 3 KEYNOTE-C93 results for Keytruda alone in first-line advanced or recurrent mismatch repair-deficient endometrial cancer. Among 299 randomized patients, median progression-free survival reached 38.2 months versus 8.4 months with carboplatin and paclitaxel. The progression-or-death hazard fell 43%, meeting one of the trial’s two primary endpoints.

The other primary endpoint, overall survival, did not show a statistically significant improvement at this analysis; follow-up continues. Grade 3 or worse treatment-related adverse events occurred in 18.1% of Keytruda recipients versus 50.7% of chemotherapy recipients. Merck plans to discuss the findings with regulators. The data support evaluation of a chemotherapy-free initial treatment option, but do not establish approval for that setting or demonstrate that patients live longer.

Sources:

• Merck — clinical results