“We are pleased to initiate FIGHT-302 – the first Phase 3 study of
pemigatinib – which we hope will add to the growing body of evidence
demonstrating its potential as a safe and effective treatment for
patients with cholangiocarcinoma with known FGFR2 rearrangements, a rare
and potentially life-threatening form of cancer,” said
Cholangiocarcinoma is a cancer that arises from the cells within the
bile ducts. It is often diagnosed late (stages III and IV) and the
prognosis is poor. It is most common in those over 70 years old and is
more common in men than women. FGFR2 fusion genes are drivers of the
disease – occurring almost exclusively in patients with intrahepatic
cholangiocarcinoma (iCCA), a subset of the disease. The incidence of
cholangiocarcinoma with FGFR2 rearrangements is increasing and is
currently estimated at 2,000-3,000 patients in the U.S.,
About FIGHT and FIGHT-302
The FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program includes several ongoing studies investigating the safety and efficacy of pemigatinib monotherapy across several FGFR-driven malignancies. Currently, the program is comprised of the recently initiated FIGHT-302 study, and three Phase 2 studies: FIGHT-201 in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 alterations; FIGHT-202 in patients with metastatic or surgically unresectable cholangiocarcinoma who have failed previous therapy, including with activating FGFR2 translocations; FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 translocations; and FIGHT-207 in patients with previously-treated, locally-advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations, irrespective of tumor type.
FIGHT-302 (NCT03656536) is an open-label, randomized, active-controlled Phase 3 trial evaluating the safety and efficacyof pemigatinib (INCB54828), Incyte’s selective oral fibroblast growth factor receptor (FGFR) inhibitor compared to the current standard of care – gemcitabine plus cisplatin chemotherapy – as a first-line treatment for adult (age ≥ 18 years) patients with metastatic or surgically unresectable cholangiocarcinoma with a known FGFR receptor 2 (FGFR2) rearrangements.
The study will enroll approximately 432 participants 1:1 into one of two treatment groups – Group A will receive pemigatinib (13.5 mg once daily [QD]) administered as continuous therapy schedule (a cycle is three weeks), and Group B will receive gemcitabine (1000 mg/m2) plus cisplatin (25 mg/m2) administered on Days 1 and 8 of every three-week cycle for up to eight cycles.
The primary endpoint of FIGHT-302 is progression free survival (PFS) across both groups, assessed by independent review per RECIST v1.1. Secondary endpoints include overall response rate (ORR), overall survival (OS), duration of response (DOR), disease control rate (DCR), safety and quality of life impact.
FIGHT-302 is currently recruiting participants; for more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03656536.
About FGFR and Pemigatinib (INCB54828)
Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating mutations, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.
Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2
and 3 which, in preclinical studies, has demonstrated selective
pharmacologic activity against cancer cells with FGFR alterations.
Forward Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the Company’s ongoing clinical development program for pemigatinib and its potential in treating cholangiocarcinoma, and the enrollment, design, timing and results of the FIGHT-302 study, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Company’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to: unanticipated delays; further
research and development and the results of clinical trials possibly
being unsuccessful or insufficient to meet applicable regulatory
standards or warrant continued development; the ability to enroll
sufficient numbers of subjects in clinical trials; determinations made
+1 302 498 6171
Michael Booth, DPhil
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