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FIGHT-302 set out to test whether the FGFR2 inhibitor pemigatinib should be used before chemotherapy in bile duct cancers driven by an FGFR2 fusion; the trial closed early after the standard of care changed, and its 2026 report showed pemigatinib delayed progression compared with chemotherapy, with similar overall survival.
Pemigatinib was approved in 2020 for previously treated cholangiocarcinoma with an FGFR2 fusion or rearrangement on the single-arm FIGHT-202 study. FIGHT-302 was the confirmatory phase 3 trial, randomising patients with untreated, unresectable or metastatic FGFR2-rearranged cholangiocarcinoma to pemigatinib or to gemcitabine and cisplatin, with progression-free survival as the primary endpoint.
The trial closed early after a change in standard of care, having randomised 167 patients. The 2026 report in the Journal of Clinical Oncology showed median progression-free survival of 8.3 months with pemigatinib against 6.8 months with chemotherapy (hazard ratio 0.58), an objective response rate of 47 percent against 15 percent, and similar overall survival (24.4 against 25.0 months), so pemigatinib delays progression in the first line but the truncated trial could not show a survival advantage.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
167 enrolled.
Trial closed early after a change in standard of care; crossover to pemigatinib allowed
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Pemigatinib | 83 | 8.3 months | 0.58 (0.39 to 0.87) | 0.0078 (nominal) | link |
| Gemcitabine + cisplatin | 84 | 6.8 months | ||||
| Objective response rate | Pemigatinib | 83 | 47% | - | - | link |
| Gemcitabine + cisplatin | 84 | 15% | ||||
| Duration of response | Pemigatinib | 83 | 14.2 months | - | - | link |
| Gemcitabine + cisplatin | 84 | 6.3 months | ||||
| Overall survival | Pemigatinib | 83 | 24.4 months | - | - | link |
| Gemcitabine + cisplatin | 84 | 25 months |
Shares Intrahepatic cholangiocarcinoma, Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma) and the tag subtype-trials.
Shares Small-molecule kinase inhibitors and the tag subtype-trials.
Shares Small-molecule kinase inhibitors and the tag subtype-trials.
Shares Small-molecule kinase inhibitors and the tag subtype-trials.
Shares Small-molecule kinase inhibitors and the tag subtype-trials.
Shares Small-molecule kinase inhibitors and the tag subtype-trials.
Shares Small-molecule kinase inhibitors and the tag subtype-trials.
Shares Small-molecule kinase inhibitors and the tag subtype-trials.