TOURMALINE - Durvalumab Safety with Gemcitabine-Based Chemotherapy Backbones

The faculty step back to compare trial data with real-world evidence before reviewing a phase 3b feasibility study. They reaffirm that the randomized, phase 3 trial remains the gold standard, while noting that the consistency of real-world evidence is reassuring. The segment then turns to the faculty reviewing TOURMALINE, an open-label phase 3b study designed to test whether durvalumab can be safely combined with gemcitabine-based chemotherapy backbones, reflecting regional variation in practice. Patients received durvalumab plus investigator choice among several gemcitabine-based regimens, and the primary end point was grade 3 or 4 adverse events possibly related to treatment within 6 months. On safety, possible treatment-related adverse events were manageable, and shortening the durvalumab infusion time did not increase infusion-related reactions, a finding with scheduling implications for busy infusion centers.