European Commission approves Keytruda (pembrolizumab) + chemotherapy, as first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma (BTC) in adults..- Merck Inc.,
Merck Inc., known as MSD outside of the United States and Canada, announced the European Commission (EC) has approved a new indication for Keytruda Merck’s anti-PD-1 therapy in combination with gemcitabine and cisplatin for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma (BTC) in adults
This approval by the EC follows a positive recommendation from the Committee for Medicinal Products for Human Use was based on overall survival (OS) results from the KEYNOTE-966 trials.
In KEYNOTE-966, Keytruda plus chemotherapy demonstrated a statistically significant improvement in OS, reducing the risk of death by 17% (HR=0.83 [95% CI, 0.72-0.95]; one-sided p=0.0034) compared to chemotherapy alone at the trial’s pre-specified final analysis for OS. Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.
In KEYNOTE-966, the incidence of Grade 3-5 adverse reactions in patients with BTC was 85% for Keytruda plus chemotherapy and 84% for chemotherapy alone.
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