Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug
Administration (FDA) has accepted for Priority Review its New Drug
Application (NDA) for pemigatinib, a selective fibroblast growth
factor receptor (FGFR) inhibitor, as a treatment for patients with
previously treated, locally advanced or metastatic
cholangiocarcinoma with FGFR2 fusions or rearrangements.
The NDA submission is based on data from the FIGHT-202 study
evaluating pemigatinib as a treatment for patients with previously
treated, locally advanced or metastatic cholangiocarcinoma. Study
results, recently presented at the European Society for Medical
Oncology (ESMO) 2019 Congress, demonstrated that in patients
harboring FGFR2 fusions or rearrangements (Cohort A), pemigatinib
monotherapy resulted in an overall response rate (ORR) of 36
percent (primary endpoint), and median duration of response (DOR)
of 7.5 months (secondary endpoint) with a median follow-up of 15
months. Adverse events were manageable and consistent with the
mechanism of action of pemigatinib.
“There is a significant need for new therapies for patients with
cholangiocarcinoma, who have limited treatment options beyond
first-line chemotherapy and often face a poor prognosis,” said
Peter Langmuir, M.D., Group Vice President, Targeted Therapeutics,
Incyte. “We are very pleased that the FDA has accepted our NDA for
Priority Review which we believe represents an important step
toward providing the first treatment option for patients with
previously treated, locally advanced or metastatic
cholangiocarcinoma with FGFR2 fusions or rearrangements. We intend
to work closely with the FDA to bring this innovative targeted
therapy to patients suffering from this devastating disease as soon
as possible.”
The FDA grants Priority Review to medicines that may offer a
major advance in treatment where none currently exists. This
designation shortens the review period to eight months compared to
12 months for Standard Review. The Prescription Drug User Fee Act
(PDUFA) target action date is May 30, 2020.
Cholangiocarcinoma is a rare cancer that forms in the bile duct.
It is classified based on its origin: intrahepatic
cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver
and extrahepatic cholangiocarcinoma occurs in the bile duct outside
the liver. Patients with cholangiocarcinoma are often diagnosed at
a late or advanced stage when the prognosis is poor.1,2 The
incidence of cholangiocarcinoma varies regionally and ranges
between 0.3 – 3.4 per 100,000 in North America and Europe.1 FGFR2
fusions or rearrangements occur almost exclusively in iCCA, where
they are observed in 10-16 percent of patients.3-5
About FIGHT-202
The FIGHT-202 Phase 2, open-label, multicenter study
(NCT02924376) is evaluating the safety and efficacy of pemigatinib
– a selective fibroblast growth factor receptor (FGFR) inhibitor –
in adult (age ≥ 18 years) patients with previously treated, locally
advanced or metastatic cholangiocarcinoma with documented FGF/FGFR
status.
Patients were enrolled into one of three cohorts – Cohort A
(FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic
alterations) or Cohort C (no FGF/FGFR genetic alterations). All
patients received 13.5 mg pemigatinib orally once daily (QD) on a
21-day cycle (two weeks on/one week off) until radiological disease
progression or unacceptable toxicity.
The primary endpoint of FIGHT-202 is overall response rate (ORR)
in Cohort A, assessed by independent review per RECIST v1.1.
Secondary endpoints include ORR in Cohorts B, A plus B, and C;
progression free survival (PFS), overall survival (OS), duration of
response (DOR), disease control rate (DCR) and safety in all
cohorts.
For more information about FIGHT-202, visit
https://clinicaltrials.gov/ct2/show/NCT02924376.
About FIGHT
The FIGHT (FIbroblast Growth factor receptor in
oncology and Hematology Trials) clinical trial
program includes ongoing Phase 2 and 3 studies investigating safety
and efficacy of pemigatinib therapy across several FGFR-driven
malignancies. Phase 2 monotherapy studies include FIGHT-202, as
well as FIGHT-201 investigating pemigatinib in patients with
metastatic or surgically unresectable bladder cancer, including
with activating FGFR3 mutations or fusions/rearrangements;
FIGHT-203 in patients with myeloproliferative neoplasms with
activating FGFR1 fusions/rearrangements; FIGHT-207 in patients with
previously treated, locally-advanced/metastatic or surgically
unresectable solid tumor malignancies harboring activating FGFR
mutations or fusions/rearrangements, irrespective of tumor type.
FIGHT-205 is a Phase 2 study investigating pemigatinib plus
pembrolizumab combination therapy and pemigatinib monotherapy in
patients with previously untreated, metastatic or unresectable
bladder cancer harboring FGFR3 mutations or fusions/rearrangements
who are not eligible to receive cisplatin. FIGHT-302 is a recently
initiated Phase 3 study investigating pemigatinib as a first-line
treatment for patients with cholangiocarcinoma with FGFR2 fusions
or rearrangements.
About FGFR and Pemigatinib
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
fusions, rearrangements, 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
treatment of previously treated, advanced/metastatic or
unresectable FGFR2 translocated 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. Additionally,
the FDA granted pemigatinib Orphan Drug designation for the
treatment of cholangiocarcinoma, a designation granted to
investigational compounds intended for the safe and effective
treatment, diagnosis or prevention of rare diseases or disorders
that affect fewer than 200,000 people.
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 whether or when pemigatinib might be approved in the U.S.
for the treatment of, and whether or when pemigatinib might provide
a treatment option for, patients with previously treated, locally
advanced or metastatic cholangiocarcinoma with FGFR2 fusions or
rearrangements, and the FIGHT clinical trial program. 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 September 30, 2019. The Company
disclaims any intent or obligation to update these forward-looking
statements.
1 Banales JM, et al. Nat Rev Gastroenterol Hepatol.
2016;13:261‒280. 2 Uhlig J, et al. Ann Surg Oncol.
2019;26:1993–2000. 3 Graham RP, et al. Hum Pathol.
2014;45:1630‒1638. 4 Farshidfar F, et al. Cell Rep.
2017;18(11):2780–2794. 5 Ross JS et al. The Oncologist.
2014;19:235–242.
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version on businesswire.com: https://www.businesswire.com/news/home/20191127005145/en/
Media Jenifer Antonacci +1 302 498 7036
jantonacci@incyte.com Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Michael Booth, DPhil +1 302 498 5914
mbooth@incyte.com
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