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

WILMINGTON, Del.–(BUSINESS WIRE)–$INCY–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.

“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.

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
by the FDA; the Company’s dependence on its relationships with its
collaboration partners; the efficacy or safety of the Company’s products
and the products of the Company’s collaboration partners; the acceptance
of the Company’s products and the products of the Company’s
collaboration partners in the marketplace; market competition; sales,
marketing, manufacturing and distribution requirements; greater than
expected expenses; expenses relating to litigation or strategic
activities; and other risks detailed from time to time in the Company’s
reports filed with the Securities and Exchange Commission, including its
Form 10-Q for the quarter ending March 31, 2019. The Company disclaims
any intent or obligation to update these forward-looking statements.

Contacts

Media
Catalina Loveman
+1 302 498 6171
[email protected]

Investors
Michael Booth, DPhil
+1 302 498 5914
[email protected]