Merck: FDA approves Keytruda in combination with gemcitabine and cisplatin

Merck announced that the U.S. FDA has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer. The approval was based on results from the Phase 3 KEYNOTE-966 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in the study’s primary endpoint of overall survival, reducing the risk of death by 17% compared to chemotherapy alone at the trial’s pre-specified final analysis for OS. Median OS was 12.7 months for KEYTRUDA plus chemotherapy versus 10.9 months for chemotherapy alone. This approval marks the sixth indication for KEYTRUDA in gastrointestinal cancers.