FOENIX-CCA2

NCT02052778 📎

Regimen

Experimental
Futibatinib 20 mg PO QD (continuous, no off-week schedule) — irreversible (covalent) FGFR1-4 inhibitor, distinct mechanism from pemigatinib (reversible)
Control
single-arm / no comparator

Population

Previously treated (≥1 prior systemic therapy) unresectable or metastatic ICC with FGFR2 fusions or other rearrangements by central next-generation sequencing (FoundationOne CDx). 100% ICC by design (FGFR2 rearrangements are ICC-exclusive). 67% had ≥2 prior lines.

Key finding

Futibatinib received FDA accelerated approval in September 2022 for previously treated FGFR2-rearranged ICC, making it the second FGFR2-targeted therapy approved for CCA. The covalent (irreversible) binding mechanism was hypothesized to overcome certain acquired resistance mutations that arise on reversible inhibitors like pemigatinib. ORR 41.7% is numerically higher than FIGHT-202 Cohort A (35.5%), though cross-trial comparison is confounded by patient selection and testing platform differences. Both trials validated FGFR2 rearrangement (not just amplification) as the actionable molecular event.

Source: PMID 36652354

Timeline

    Guideline citations

    • NCCN BTC (p.35)