Volume 9 Issue 6 2024 | A. Vogel, V. Sahai, A. Hollebecque, G. M. Vaccaro, D. Melisi, R. M. Al Rajabi, A. S. Paulson, M. J. Borad, D. Gallinson, A. G. Murphy, D.-Y. Oh, E. Dotan, D. V. Catenacci, E. Van Cutsem, C. F. Lihou, H. Zhen, M. L. Veronese, G. K. Abou-Alfa
This study reports the final results from the FIGHT-202 trial, an open-label, single-arm, phase II study evaluating the efficacy and safety of pemigatinib in patients with previously treated advanced or metastatic cholangiocarcinoma (CCA) with FGFR2 fusions or rearrangements. The primary endpoint was the objective response rate (ORR) in cohort A, with secondary endpoints including duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. A total of 147 patients were enrolled, with 145 discontinuing treatment due to progressive disease, withdrawal, or adverse events. The median follow-up was 45.4 months. The ORR in cohort A was 37.0%, with a median DOR of 9.1 months, median PFS of 7.0 months, and median OS of 17.5 months. The most common treatment-emergent adverse events (TEAEs) were hyperphosphatemia (58.5%), alopecia (49.7%), and diarrhea (47.6%). No patients with other or no FGFR/FGFR alterations responded to pemigatinib. The study concluded that pemigatinib demonstrated durable responses and prolonged OS with manageable AEs in patients with advanced or metastatic CCA with FGFR2 alterations.This study reports the final results from the FIGHT-202 trial, an open-label, single-arm, phase II study evaluating the efficacy and safety of pemigatinib in patients with previously treated advanced or metastatic cholangiocarcinoma (CCA) with FGFR2 fusions or rearrangements. The primary endpoint was the objective response rate (ORR) in cohort A, with secondary endpoints including duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. A total of 147 patients were enrolled, with 145 discontinuing treatment due to progressive disease, withdrawal, or adverse events. The median follow-up was 45.4 months. The ORR in cohort A was 37.0%, with a median DOR of 9.1 months, median PFS of 7.0 months, and median OS of 17.5 months. The most common treatment-emergent adverse events (TEAEs) were hyperphosphatemia (58.5%), alopecia (49.7%), and diarrhea (47.6%). No patients with other or no FGFR/FGFR alterations responded to pemigatinib. The study concluded that pemigatinib demonstrated durable responses and prolonged OS with manageable AEs in patients with advanced or metastatic CCA with FGFR2 alterations.