Katy Marshall

GI Oncology Now

Clinically actionable genomic alterations in patients with cholangiocarcinoma (CCA) include fibroblast growth factor receptor 2 (FGFR2) fusions and rearrangements.In the phase 2 FIGHT-202 study, pemigatinib, an oral inhibitor of FGFR1-3, showed efficacy in patients who had previously received treatment for advanced or metastatic CCA with FGFR2 alterations.A study from Arndt Vogel, MD, PhD, and colleagues <a href="https://www.sciencedirect.com/science/article/pii/S2059702924012572" target="_blank" rel="noopener">published in ESMO Open</a> detailed final outcomes from the FIGHT-202 study&rsquo;s extended follow-up period.Researchers included patients with previously treated advanced or metastatic CCA with FGFR2 fusions or rearrangements (cohort A), other FGF/FGFR alterations (cohort B), or no FGF/FGFR alterations (cohort C). Participants received pemigatinib 13.5 mg once per day for 21-day cycles with 2 weeks on and 1 week off until achieving disease progression or unacceptable toxicity.The study&rsquo;s primary end point was objective response rate (ORR) in cohort A. Secondary end points included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.For the 147 participants, the median follow-up period was 45.4 months. Upon final analysis, 145 patients had ended treatment, citing progressive disease (71.4%), withdrawal by patient (8.2%), or adverse events (AEs; 6.8%).In cohort A, the ORR was 37% (95% CI, 27.9-46.9), with 3 patients demonstrating complete response and 37 patients demonstrating partial responses. The median PFS was 7.0 months, median OS was 17.5 months, and median DOR was 9.1 months.The most reported treatment-related AEs (TRAEs) included hyperphosphatemia (58.5%), alopecia (49.7%), and diarrhea (47.6%). Of all the participants, 15 (10.2%) discontinued pemigatinib due to TRAEs.&ldquo;Pemigatinib demonstrated durable response and prolonged OS with manageable [AEs] in patients with previously treated, advanced/metastatic CCA with FGFR2 alterations in the extended follow-up period of FIGHT-202,&rdquo; the investigators wrote.

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FIGHT-202: Analyzing the Effects of Pemigatinib in Patients With Cholangiocarcinoma

Participants received pemigatinib 13.5 mg once per day for 21-day cycles with 2 weeks on and 1 week off.