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AACR 2023: Pembrolizumab Plus Chemotherapy for Advanced Biliary Tract Cancer

By: Joshua Swore, PhD
Posted: Thursday, April 20, 2023

Pembrolizumab plus gemcitabine/cisplatin may prove to be an effective and safe therapy for patients with unresectable locally advanced or metastatic biliary tract cancer, according to a presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023 (Abstract CT008). According to Robin Kate Kelley, MD, of the University of California, San Francisco, and colleagues, these findings are “meaningful in this difficult-to-treat family of cancers.”

“These data reinforce that patients with advanced biliary tract cancer may have durable immune responses and prolonged survival when an immune checkpoint inhibitor, such as pembrolizumab, is combined with first-line gemcitabine plus cisplatin chemotherapy,” said Dr. Kelley in an AACR press release.

A total of 1,069 patients were enrolled in the randomized, double-blind, phase III KEYNOTE-966 study; 533 received pembrolizumab plus gemcitabine/cisplatin, and 536 received a placebo plus gemcitabine/cisplatin. The authors stratified the study by region, stage, and tumor origin and used a final analysis cutoff at the first interim analysis.

The authors reported that patients treated with pembrolizumab had a median overall survival of 12.7 months, compared with 10.9 months for patients who did not receive pembrolizumab (P = .0034). Median progression-free survival was 6.5 months with the pembrolizumab-based combination therapy and 5.6 months with the doublet plus placebo (P = .0225). The objective response rates were similar between both groups at 28.7% vs 28.5%, respectively. The duration of response was found to be longer for patients treated with pembrolizumab at 9.7 months versus patients not treated with pembrolizumab at 6.9 months.

The study reported that grade 3 to 5 adverse events occurred in 85.3% of patients treated with pembrolizumab and 84.1% of patients not treated with pembrolizumab. However, immune-mediated events were more frequent in patients treated with pembrolizumab (22.1% vs. 12.9%).

Disclosure: For full disclosures of the study authors, visit

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