- If approved, pemigatinib will be the first
targeted therapy indicated in the EU for this indication
Incyte (Nasdaq:INCY) today announced that the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) has issued a positive opinion recommending the conditional
marketing authorization of pemigatinib for the treatment of adults
with unresectable locally advanced or metastatic cholangiocarcinoma
with a fibroblast growth factor receptor 2 (FGFR2) fusion or
rearrangement that is relapsed or refractory, after at least one
line of systemic therapy.
“The positive CHMP opinion is a crucial milestone for patients
with cholangiocarcinoma, who often have very limited treatment
options due to the difficulty of identifying patients during the
early disease stages,” said Peter Langmuir, M.D., Group Vice
President, Oncology Targeted Therapeutics, Incyte. “Following the
recent FDA approval of pemigatinib (Pemazyre®), we are delighted to
be closer to offering the first targeted therapy in Europe to
benefit these patients.”
The CHMP opinion is based on data from the FIGHT-202 study
evaluating the safety and efficacy of pemigatinib in adult patients
with previously treated, locally advanced or metastatic
cholangiocarcinoma with documented FGF/FGFR status. The CHMP’s
opinion to recommend the use of pemigatinib is now being reviewed
by the European Commission, which has the authority to grant
marketing authorizations for medicinal products in the European
Union (EU). If approved, pemigatinib will be the first targeted
treatment in the EU indicated for patients with unresectable
locally advanced or metastatic cholangiocarcinoma with a fibroblast
growth factor receptor 2 (FGFR2) fusion or rearrangement and would
be commercialized under the brand name Pemazyre.
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 poor1,2. In Europe,
the incidence of cholangiocarcinoma ranges between 6,000 –
8,0003,4. FGFR2 fusions or rearrangements occur almost exclusively
in iCCA, where they are observed in 10-16 percent of
patients5,6,7.
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; 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-302 is a 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.
About Incyte Incyte is a Wilmington, Delaware-based,
global biopharmaceutical company focused on finding solutions for
serious unmet medical needs through the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit Incyte.com and follow
@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 EU for the treatment of, and whether or
when pemigatinib might provide a successful treatment option for,
patients with unresectable locally advanced or metastatic
cholangiocarcinoma, 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 European regulatory authorities or other
regulatory authorities, including the U.S. 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, 2020. 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 Kirstein MM, Vogel A. Visc Med 2016; 32:
395-400. 4 Countries factored include: UK, Germany, France, Spain,
Italy, Switzerland, Denmark, Finland, Poland and Austria 5 Graham
RP, et al. Hum Pathol. 2014;45:1630‒1638. 6 Ang C. J. Gastroenterol
Hepatol. 2015;30:1116‒1122. 7 Ross JS et al. The Oncologist.
2014;19:235–242.
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Incyte: Media
Catalina Loveman Executive Director, Public Affairs +1 302 498 6171
cloveman@incyte.com
Ela Zawislak Director, Public Affairs +41 21 343 3113
ezawislak@incyte.com
Investors Dr. Michael Booth Division VP, IR & Global
Responsibility +1 302 498 5914 mbooth@incyte.com
Christine Chiou Senior Director, Investor Relations +1 302 274
4773 cchiou@incyte.com
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