The FIGHT-302 trial evaluated pemigatinib against gemcitabine plus cisplatin as a first-line treatment for advanced cholangiocarcinoma with FGFR2 rearrangements. Pemigatinib significantly prolonged progression-free survival and improved the objective response rate compared to chemotherapy. Overall survival was similar between the treatment groups.
Study
|
Phase III, randomized, global trial [FIGHT-302; NCT03656536] |
| Advanced cholangiocarcinoma with FGFR2 rearrangement |
| Pemigatinib (n=83) vs gemcitabine plus cisplatin (n=84)
|
Efficacy
|
ORR: 47% vs 15% (OR 5.57 [2.54-12.24]) |
| mPFS: 8.3 mos vs 6.8 mos (HR 0.58 [0.39-0.87]) |
| mDOR: 14.2 mos vs 6.3 mos (HR 0.40 [0.16-1.01]) |
| mOS: 24.4 mos vs 25.0 mos (HR 1.095 [0.733-1.637])
|
Safety
|
Grade >=3 AE: Neutropenia (0% vs 30.1%), anemia (14.5% vs 52.1%), hyperphosphatemia (1 pt vs. none) |
| Serious TEAE: 27.7% vs 23.3% |
| TEAE leading to study drug discontinuation: 6.0% vs 11.0% |
| Fatal TEAE: 3.6% vs 0%
|
J Clin Oncol 2026;44:2187-2197
http://doi.org/10.1200/JCO-26-00788
Reviewed by Ulas D. Bayraktar, MD on Aug 20, 2026
