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Updated Results of the FIGHT-202 Study Reinforced the Efficacy and Safety of Pemigatinib for Previously Treated Locally Advanced/Metastatic CCA

2021 Year in Review: Cholangiocarcinoma — December 17, 2021

Updated results from the FIGHT-202 study supported the primary data that second-line pemigatinib treatment resulted in efficacy and sustained tolerability in patients with CCA harboring FGFR2 rearrangements/fusions.

FIGHT-202 is a single-arm, phase 2, open-label, multicenter study (ClinicalTrials.gov Identifier: NCT02924376) that investigated the efficacy and safety of the selective, oral FGFR1-3 inhibitor pemigatinib in patients with previously treated advanced/metastatic cholangiocarcinoma (CCA) who had progressed on ≥1 prior therapies. Mature efficacy and safety data from the FIGHT-202 trial were reported at the 2021 American Society of Clinical Oncology Annual Meeting. Pemigatinib was approved in 2020 by the US Food and Drug Administration (FDA) for the treatment of adults with previously treated, unresectable locally advanced or metastatic CCA with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test.

In the FIGHT-202 study, eligible adults with disease progression after ≥1 prior treatments and documented FGF/FGFR gene status were assigned to cohort A (FGFR2 gene rearrangements/fusions), cohort B (other FGF/FGFR gene alterations), or cohort C (no FGF/FGFR gene alterations). All eligible patients received oral pemigatinib 13.5 mg once daily (21-day cycle; 2 weeks on, 1 week off) until disease progression or unacceptable toxicity. The primary end point was the centrally confirmed objective response rate (ORR) of cohort A. Secondary end points included ORR (cohort B, cohorts A and B combined, and cohort C), duration of response (DOR), duration of complete response, progression-free survival, overall survival (OS), and safety. A post-hoc analysis was conducted in cohort A to evaluate median OS in responders compared with nonresponders. The data cutoff date for this analysis was April 7, 2020.

At data cutoff, the current analysis included a total of 147 patients. Of these participants, 108 were enrolled in cohort A, 20 in cohort B, and 17 in cohort C. At a median follow-up of 30.4 months, the median treatment duration was 5.9 months and 9.3% of patients remained on therapy in cohort A. The centrally confirmed ORR in cohort A was 37.0%, including 4 complete responders and 36 partial responders. The median DOR was 8.1 months (95% confidence interval, 5.7-13.1). No responses were reported in cohorts B and C. The updated median OS was 17.5 months, which was longer than that in historical data. Furthermore, post-hoc analysis revealed that the median OS was prolonged for responders (n = 40; 30.1 months) compared with nonresponders (n = 68; 13.7 months) in cohort A.

The safety profile in the current analysis was similar to that in the primary analysis, and no new safety signals were observed. In the total population, the most frequently reported treatment-emergent adverse events (TEAEs) included hyperphosphatemia (58.5%), alopecia (49.7%), diarrhea (46.9%), fatigue (43.5%), nausea (41.5%), and dysgeusia (40.8%). TEAEs led to treatment discontinuation in 10.2% of patients and treatment interruption in 42.2% of participants.

These results supported primary data and indicated that pemigatinib treatment was associated with continued and durable responses, along with sustained tolerability, in patients with CCA who harbor FGFR2 rearrangements/fusions.

Source: Abou-Alfa GK, Sahia V, Hollebecque A, et al. Pemigatinib for previously treated locally advanced/metastatic cholangiocarcinoma (CCA): update of FIGHT-202. J Clin Oncol. 2021;39(suppl_15):4086-4086.

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