The Absolute Effect / Oncology Evidence / Evidence Index
FIGHT-302
In untreated advanced FGFR2-rearranged cholangiocarcinoma, does pemigatinib improve progression-free survival over gemcitabine-cisplatin?
Registry: NCT03656536 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.
Phase III randomized global trial; n=167; early closure after standard-of-care change.Primary-source evidence summaryStudy design, population and eligibility
Phase III randomized global trial; n=167; early closure after standard-of-care change.
Advanced cholangiocarcinoma with FGFR2 rearrangement.
Treatment and comparator
Intervention: Pemigatinib 13.5 mg daily, 2 weeks on/1 week off.
Comparator: Gemcitabine/cisplatin up to 8 cycles; crossover allowed.
Endpoints
PFS primary.
Key efficacy and clinical outcomes
Median PFS 8.3 vs 6.8 mo (HR 0.58; nominal p=.0078); ORR 47% vs 15.5%; OS 24.4 vs 25.0 mo, confounded by crossover.
Source-reported outcome visualization
Values are reproduced from the cited report; bars are scaled within this figure. First-line FGFR2-rearranged advanced cholangiocarcinoma
Median survival and hazard ratios are not fixed-time event risks; NNT is not inferred from them.
Toxicity and treatment burden
Grade ≥3 TEAEs 78% vs 67%; hyperphosphataemia, stomatitis, ocular and nail/skin toxicity.
Absolute effect and NNT/NNH
Small sample and early closure; OS confounded by crossover/subsequent FGFR inhibitors. Distinct from FIGHT-202.
NNT/NNH is not calculated unless a directly reported, comparable fixed-time risk difference supports it. Median survival and hazard ratios alone do not provide an NNT.
Critical interpretation and limitations
Small sample and early closure; OS confounded by crossover/subsequent FGFR inhibitors. Distinct from FIGHT-202.
This page is an evidence summary, not a substitute for multidisciplinary assessment or patient-specific decision-making.
Current-practice context
Review date: 9 November 2026. Primary publication and selected follow-up sources were reviewed. Full disease-specific guideline, regulatory-label and sequencing audit remains pending; verify current local recommendations and biomarker eligibility before clinical application.