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First-Line Pembrolizumab Plus Chemotherapy for Advanced Biliary Tract Cancer: China Subgroup Analysis of the
Zhenggang Ren1, Tingbo Liang2, Shanzhi Gu3
1Department of Hepatic Oncology, Liver Cancer Institute, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, Shanghai, China.
Advances in Therapy
|May 23, 2026
Summary
In advanced biliary tract cancer, pembrolizumab combined with chemotherapy improved overall survival compared to placebo. This first-line treatment showed no new safety concerns in Chinese patients.
Area of Science:
- Oncology
- Gastroenterology
- Clinical Trials
Background:
- The KEYNOTE-966 study evaluated pembrolizumab plus gemcitabine and cisplatin in advanced biliary tract cancer (BTC).
- Global results demonstrated improved overall survival (OS) without new safety signals.
- This analysis specifically examines outcomes in Chinese participants.
Purpose of the Study:
- To assess the efficacy and safety of first-line pembrolizumab plus chemotherapy in advanced BTC patients in China.
- To analyze overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR).
Main Methods:
- Adults with advanced BTC were randomized to pembrolizumab or placebo with gemcitabine and cisplatin.
- Treatment was administered intravenously every 3 weeks.
- OS, PFS, ORR, DOR, and safety were primary and secondary endpoints, assessed per RECIST v1.1.
Main Results:
- 158 Chinese participants were enrolled; 75 received pembrolizumab, 83 received placebo.
- Median OS was 14.1 months with pembrolizumab vs. 9.9 months with placebo (HR, 0.74).
- Grade 3/4 treatment-related adverse events were similar between groups (71.6% vs. 70.7%).
Conclusions:
- First-line pembrolizumab plus gemcitabine and cisplatin demonstrated a numeric OS improvement in Chinese advanced BTC patients.
- The safety profile was consistent with the global KEYNOTE-966 study.
- No new safety signals were identified in this subgroup analysis.
