The abstract is read at the publisher; the summary is JClub's.
In a single-center phase II trial in 42 patients with advanced biliary cancer, pembrolizumab plus GM-CSF achieved a confirmed ORR of 12% (95% CI, 4–26).
- Why it matters: Immune checkpoint inhibitors have limited monotherapy activity in biliary cancers, and prior GM-CSF combinations in other tumors suggested potential synergy worth testing after chemotherapy.
- What they did: Patients received pembrolizumab 200 mg IV every 21 days with two cycles of GM-CSF 250 μg subcutaneously on days 1–14, with ORR as the primary endpoint.
- The result: The regimen was well tolerated (7% grade 3–4 treatment-related events; 10% serious adverse events), showed 26% 6-month PFS ongoing, and paired biopsies indicated increased CD8+ T cells and antigen processing pathway upregulation.
The findingWhy it mattersWhat they didThe result
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