Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Pemigatinib as a First-Line Therapy for Cholangiocarcinoma

WILMINGTON, DE, USA I June 04, 2019 I Incyte (Nasdaq:INCY) today announced that the first patient has been treated in FIGHT-302, an open-label Phase 3 study evaluating pemigatinib (INCB54828), its selective fibroblast growth factor receptor (FGFR) inhibitor, compared to gemcitabine with cisplatin chemotherapy, the current standard of care, as a first-line therapy for patients with metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer) and activating FGFR2 rearrangements.

“Most patients that present with cholangiocarcinoma, like those patients to be enrolled in the FIGHT-302 study, have an advanced form of the disease that cannot be surgically removed, and the majority do not respond to the current standard of care, demonstrating the significant need for new treatment options.”

“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 Steven Stein, M.D., Chief Medical Officer, Incyte. “Most patients that present with cholangiocarcinoma, like those patients to be enrolled in the FIGHT-302 study, have an advanced form of the disease that cannot be surgically removed, and the majority do not respond to the current standard of care, demonstrating the significant need for new treatment options.”

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., Europe and Japan.

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 efficacy of 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. The U.S. Food and Drug Administration (FDA) has granted pemigatinib Breakthrough Therapy designation for the second-line treatment of cholangiocarcinoma. The FDA’s Breakthrough Therapy designation is designed to expedite the development and review of drugs for serious conditions that have shown encouraging early clinical results and may demonstrate substantial improvements over available medicines.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.

Follow @Incyte on Twitter at https://twitter.com/Incyte.

SOURCE: Incyte

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