Keytruda + chemotherapy significantly improved overall survival versus chemotherapy in first line advanced or unresectable biliary tract cancer in KEYNOTE-966 trial
Merck Inc., ,known as MSD outside of the United States and Canada, announced positive results from the Phase III KEYNOTE-966 trial
In the final analysis of this trial, Keytruda, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus chemotherapy alone for the first-line treatment of patients with advanced or unresectable biliary tract cancer (BTC).
The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting and will be submitted to regulatory authorities.
About KEYNOTE-966 ; KEYNOTE-966 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT04003636) evaluating Keytruda in combination with gemcitabine and cisplatin compared to placebo plus gemcitabine and cisplatin for the first-line treatment of advanced and/or unresectable BTC. The primary endpoint was OS, and the secondary endpoints included progression-free survival, objective response rate, duration of response and safety. The trial enrolled 1,069 patients who were randomized to receive Keytruda (200 mg every three weeks for up to approximately two years) plus gemcitabine and cisplatin, or placebo plus gemcitabine and cisplatin.
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