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Targeted Therapies for Bladder Cancer and Beyond: Overview and Current Status of FGFR Inhibitors

Ignacio Duran, MD, PhD
Released: June 14, 2021

Pemigatinib in Previously Treated Cholangiocarcinoma

Pivotal, Phase II FIGHT-202 of Pemigatinib in Previously Treated Cholangiocarcinoma With FGFR2 Fusions: Study Design

The pivotal, multicenter, open-label, single-arm phase II FIGHT-202 trial assessed the efficacy and safety of pemigatinib in previously treated cholangiocarcinoma with FGFR fusions. Patients were tested for FGFR fusions and, based on this status, were allocated to 3 different cohorts. Cohort A was for patients with FGFR2 fusions, cohort B was for those with other FGF/FGFR genetic alterations, and cohort C was for no FGF/FGFR genetic alterations. For all cohorts, patients received oral pemigatinib at 13.5 mg once daily for 14 consecutive days, followed by 7 days off therapy. The primary endpoint of this study for cohort A was overall response rate (ORR) and secondary endpoints were PFS, OS, safety, DoR, and disease control rate.[42]

Responses in Patients With FGFR2 Fusion/Rearrangement in the Phase II FIGHT-202 trial

The study included 107 patients with locally advanced unresectable or metastatic cholangiocarcinoma and an FGFR2 gene fusion or rearrangement. Among these patients, the ORR was 36% (95% CI: 27%-45%), including 3 complete responses. The median DoR was 9.1 months, and 63% of patients receiving pemigatinib had response to treatment lasting ≥6 months and 18% had a response lasting ≥12 months.[42]

PFS and OS in Patients With FGFR2 Fusion/Rearrangement in the Phase II FIGHT-202 Trial

For the patient population with an FGFR2 gene fusion or rearrangement, median PFS was 6.9 months (95% CI: 6.2-9.6). Preliminary OS data were encouraging with a median OS of 21.1 months (95% CI: 14.8-not estimable). Follow-up will continue as these data are not yet mature.[42]

Safety of Pemigatinib in the Phase II FIGHT-202

Overall, hyperphosphatemia was the most common all-grade AE regardless of cause (88 [60%] of 146 patients). Ninety-three (64%) patients had a grade ≥3 AE (regardless of cause); the most frequent were hypophosphatemia (18 [12%]), arthralgia (9 [6%]), stomatitis (8 [5%]), hyponatremia (8 [5%]), abdominal pain (7 [5%]), and fatigue (7 [5%]). Sixty-five (45%) patients had serious AEs; the most frequent were abdominal pain (7 [5%]), pyrexia (7 [5%]), cholangitis (5 [3%]), and pleural effusion (5 [3%]). Overall, 71 (49%) patients died during the study, most frequently because of disease progression (61 [42%]); no deaths were deemed to be treatment related.[42]

Based on data from the FIGHT-202 trial, pemigatinib received accelerated FDA approval in April 2017 in previously treated CCA patients harboring FGFR2 fusions or other rearrangements. This was followed in March 2021, with an approval in Europe in the same disease setting. 

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