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A prior randomized, phase 3 study showed that adding the anti–PD-L1 immune checkpoint inhibitor durvalumab to first-line chemotherapy with gemcitabine and cisplatin significantly improved overall survival in patients with advanced biliary cancer (NEJM JW Oncol Hematol Aug 2022 and NEJM Evid 2022 Jun 1; [e-pub]).
Now, to evaluate the anti–PD-1 immune checkpoint inhibitor pembrolizumab in this setting, investigators conducted an industry-sponsored, international, randomized, phase 3 trial (KEYNOTE-966) in which 1609 untreated patients with advanced biliary cancer received treatment every 3 weeks with gemcitabine (no maximum duration), cisplatin (maximum, 8 cycles), and pembrolizumab or placebo (maximum, 35 cycles). Among the patients, 45% were…