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Ref Type Abstract
PMID
Authors Jordi Rodon; Silvia Damian; Muhammad Furqan; Jesus Garcia-Donas; Hiroo Imai; Antoine Italiano; Iben Spanggaard; Makoto Ueno; Tomoya Yokota; Luisa Veronese; Natalia Oliveira; Xin Li; Aidan Gilmartin; Lipika Goyal
Title Abstract CT016: Clinical and translational findings of pemigatinib in previously treated solid tumors with activating FGFR1-3 alterations in the FIGHT-207 study
Journal Vol Issue Date Pages Journal Short Title
Cancer Research 82 8_Supplement April 14 2023
URL https://aacrjournals.org/cancerres/article/83/8_Supplement/CT016/725419/Abstract-CT016-Clinical-and-translational-findings
Abstract Text Background: Fibroblast growth factor receptor (FGFR) alterations are promising targets in different tumors. We report results of FIGHT-207, an open-label, single-arm phase 2 study of pemigatinib, a potent, selective FGFR1-3 inhibitor, in patients with previously treated unresectable or metastatic FGFR-altered solid tumors (NCT03822117). Methods: Patients were assigned to cohorts A (FGFR1-3 fusions), B (FGFR1-3 activating non-kinase domain mutations), and C (FGFR1-3 kinase domain mutations and alterations of unknown significance) and received continuous 13.5 mg pemigatinib once daily. Prior FGFR inhibitor treatment was prohibited. The primary endpoint was objective response rate (ORR) per RECIST v1.1 or RANO as confirmed by independent central review. Results: 107 patients were enrolled and assigned to cohorts A (n=49), B (n=32), and C (n=26). ORR in cohorts A, B, and C was 26.5%, 9.4%, and 3.8%, respectively. Responses were observed for multiple tumor types, including gliomas and gynecologic and pancreatic tumors (Table). Notably, we saw responses for several infrequent FGFR alterations, including an FGFR1 kinase domain mutation (K656E) and an FGFR2 extracellular in-frame deletion (FGFR2 I291_Y308Del). Among patients in cohorts A+B with centrally confirmed FGFR alterations, BAP1 co-alterations were observed in 47% (7/15) of responders, and TP53 co-alterations were present in 43% (23/53) of nonresponders. Safety was consistent with prior reports. Conclusions: In addition to cholangiocarcinoma, pemigatinib showed clinical activity in gliomas, gynecologic tumors, and pancreatic cancer and safety was consistent with prior reports. We observed responses in patients with previously unreported FGFR alterations, suggesting that a broader population of patients may benefit from FGFR inhibitors. Further correlative work to predict response to therapy is needed to better identify these patients.

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