The phase IIIb TOURMALINE study evaluated the safety and efficacy of first-line durvalumab (1500 mg IV) combined with one of seven investigator-chosen gemcitabine-based chemotherapy regimens in 142 adults with advanced biliary tract cancer (aBTC), including those with poor prognosis, over a median follow-up of ~11.6 months.
Grade 3/4 possibly related AEs occurred in 50.7% of participants (95% CI 42.19–59.19) within 6 months, with no treatment-related deaths from serious AEs of special interest. Median PFS was 7.39 months, median OS was 13.50 months, and ORR was 33.1% (95% CI 25.44–41.48).
Single-arm design with no comparator group limits causal inference; the 142-participant cohort is relatively small and interim in nature; real-world generalizability is constrained by the investigator's-choice regimen design, which introduces heterogeneity across seven different chemotherapy backbones.
Durvalumab can be combined with a range of gemcitabine-based regimens beyond the standard gem-cis doublet with a manageable safety profile, even in aBTC patients with less favorable disease characteristics. The abbreviated 30-minute durvalumab infusion did not increase infusion-related reactions, supporting its practical use in busy oncology settings.
