FIGHT-302 — Pemigatinib Versus Gemcitabine Plus Cisplatin as First-Line Therapy for Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement

Phase 3 · 2026 · Cholangiocarcinoma

Design

Open-label, randomized, active-controlled phase 3 trial of first-line pemigatinib versus gemcitabine plus cisplatin, with crossover to pemigatinib permitted on progression. 4,563 patients were prescreened and 167 randomized (83 pemigatinib, 84 chemotherapy) before early closure prompted by a change in the first-line standard of care.

Population

Previously untreated unresectable or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.

Primary Endpoint

progression-free survival (PFS)

Key Result

First-line pemigatinib prolonged median PFS versus gemcitabine/cisplatin (8.3 vs 6.8 months; HR 0.58, 95% CI 0.39–0.87; nominal P=.0078), with a markedly higher objective response rate (47% vs 15%) and longer median duration of response (14.2 vs 6.3 months). Median overall survival was similar (24.4 vs 25.0 months), confounded by crossover. The study closed early after the first-line standard of care changed.

Guideline Impact

First-line FGFR2-rearranged cholangiocarcinoma