The FDA approved pembrolizumab (Keytruda, Merck) to be used with gemcitabine and cisplatin for locally advanced, unresectable or metastatic biliary tract cancer.
Efficacy was evaluated in KEYNOTE-966, a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 1,069 patients with locally advanced, unresectable or metastatic biliary tract cancer who had not received prior systemic therapy for advanced disease. Patients were randomized in a 1:1 fashion to receive either pembrolizumab on day 1 plus gemcitabine and cisplatin on day 1 and day 8 every three weeks, or placebo on day 1 plus gemcitabine and cisplatin on the same schedule. Treatment continued until unacceptable toxicity or disease progression. Cisplatin was administered for a maximum of eight cycles; gemcitabine was continued at the physician’s discretion. Pembrolizumab or placebo was continued until disease progression, unacceptable toxicity or a maximum of two years.
The major efficacy measure was overall survival (OS). Pembrolizumab plus chemotherapy demonstrated a statistically significant improvement in OS compared with placebo plus chemotherapy, with a hazard ratio of 0.83 (95% CI, 0.72-0.95; one-sided P value=0.0034). The median OS duration was 12.7 months (95% CI, 11.5-13.6 months) and 10.9 months (95% CI, 9.9-11.6 months) in the respective arms.
Adverse reactions leading to the interruption of pembrolizumab occurred in 55% of patients. The most common adverse reactions or laboratory abnormalities (≥2%) leading to interruption were decreased neutrophil count, decreased platelet count, anemia, decreased white blood cell count, pyrexia, fatigue, cholangitis, increased alanine transaminase, increased aspartate aminotransferase and biliary obstruction.
View full prescribing information for Keytruda.
—GEN Staff
Based on a press release from the FDA.