Durvalumab with gemcitabine-based chemotherapy regimens in advanced biliary tract cancer: primary results from the phase IIIb TOURMALINE study.
Combining immunotherapy with standard chemotherapy remains safely effective for advanced bile duct cancer across different drug combinations in real-world settings.
TOURMALINE (NCT05771480) enrolled 142 advanced BTC patients who received durvalumab with one of seven gemcitabine-based chemotherapy regimens in a close-to-real-world setting (72.5% metastatic). Primary safety endpoint was met with manageable grade 3/4 related AEs (50.7%), and efficacy outcomes (PFS 7.39 mo, OS 13.50 mo, ORR 33.1%) are consistent with TOPAZ-1, supporting this approach across diverse gemcitabine backbones.
What the study was
- Study design
- phase_3_trial
- Category
- hepatobiliary oncology
- Maturity
- Validated
- Journal
- Journal of Hepatology
Why it surfaced
Phase IIIb real-world study extending TOPAZ-1 data to seven gemcitabine backbone combinations in aBTC, including poor-prognosis patients excluded from pivotal trials. Published in J Hepatol (IF~26). Confirms broad feasibility of durvalumab + gemcitabine combinations and supports 30-min infusion protocol.
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