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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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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
FGFR2 I291_Y308del deletion unknown FGFR2 I291_Y308del results in the deletion of eighteen amino acids in the Fgfr2 protein from amino acids 291 to 308 (UniProt.org). I291_Y308del has been identified in the scientific literature (Cancer Res (2023) 83 (8_Supplement): CT016), but has not been biochemically characterized and therefore, its effect on Fgfr2 protein function is unknown (PubMed, Dec 2023).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR1 K656E diffuse astrocytoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-207), Pemazyre (pemigatinib) treatment resulted in a partial response with an 80.7% decrease in target lesion and a progression-free survival of 8 months in a patient with diffuse astrocytoma harboring FGFR1 K656E (Cancer Res (2023) 83 (8_Supplement): CT016; NCT03822117). detail...
FGFR3 Y373C urinary bladder cancer predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-207), Pemazyre (pemigatinib) treatment resulted in a partial response with a 50.8% decrease in target lesion and a progression-free survival of 6.2 months, and stable disease with a 30% decrease in target lesion and progression-free survival of 3.9 months in two patients with bladder cancer harboring FGFR3 Y373C (Cancer Res (2023) 83 (8_Supplement): CT016; NCT03822117). detail...
FGFR2 C382R cholangiocarcinoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-207), Pemazyre (pemigatinib) treatment resulted in a partial response with a 49.7% decrease in target lesion and a progression-free survival of 6 months in a patient with cholangiocarcinoma harboring FGFR2 C382R (Cancer Res (2023) 83 (8_Supplement): CT016; NCT03822117). detail...
FGFR2 I291_Y308del cholangiocarcinoma predicted - sensitive Pemigatinib Case Reports/Case Series Actionable In a Phase II trial (FIGHT-207), Pemazyre (pemigatinib) treatment resulted in a partial response with a 42.5% decrease in target lesion and a progression-free survival of 14.8 months in a patient with cholangiocarcinoma harboring FGFR2 I291_Y308del (Cancer Res (2023) 83 (8_Supplement): CT016; NCT03822117). detail...