MONTREAL, Sept. 17, 2021 /CNW/ - Incyte (NASDAQ: INCY)
today announced that Health Canada has granted a Notice of
Compliance with conditions for Pemazyre® (pemigatinib),
a selective fibroblast growth factor receptor (FGFR) inhibitor, for
the treatment of adults with previously treated, unresectable
locally advanced or metastatic cholangiocarcinoma with a fibroblast
growth factor receptor 2 (FGFR2) fusion or other rearrangement.
"For appropriate patients with cholangiocarcinoma, the approval
of Pemazyre in Canada offers
patients hope with a new potential treatment option after their
cancer has returned, following the failure of first-line
treatment," said Durhane
Wong-Rieger, Ph.D., President and CEO, Canadian Organization
for Rare Disorders.
"Cholangiocarcinoma is a rare cancer of the bile duct with
limited treatment options. As a result, patients face a poor
prognosis," said Dr. Vincent Tam,
MD, Medical Oncologist, Tom Baker Cancer Centre. "With the approval
of Pemazyre, we now have a targeted treatment option for those
patients with progressive disease after first-line
chemotherapy."
The conditional approval 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 demonstrated that in
patients harbouring FGFR2 fusions or rearrangements (Cohort A),
pemigatinib monotherapy resulted in an overall response rate (ORR)
of 35.5 percent (primary endpoint) and median duration of response
(DOR) of 9.1 months (secondary endpoint) with a median follow-up of
15.4 months. Adverse events observed included serous retinal
detachment (SRD) and hyperphosphatemia. The most common
adverse reactions (incidence ≥15%) are hyperphosphatemia, alopecia,
diarrhea, fatigue, nail toxicity, dysgeusia, nausea, constipation,
stomatitis, dry mouth, decreased appetite, vomiting, dry eye,
arthralgia, abdominal pain, hypophosphatemia, dry skin, edema
peripheral, weight decreased, headache, urinary tract infection,
dehydration, hypercalcemia, and palmar-plantar erythrodysaesthesia
syndrome.
"We are pleased that Health Canada has granted conditional
marketing authorization for Pemazyre and Incyte welcomes the
opportunity to serve the cholangiocarcinoma community with this
much-needed treatment option," said Josée Brisebois, Ph.D.., Head
of Medical Affairs, Incyte Biosciences Canada. "Incyte will strive
to secure rapid access across Canada to this innovative targeted therapy to
patients suffering from this difficult disease."
Cholangiocarcinoma is a rare cancer that forms in the bile duct.
It is classified based on its anatomical 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% of patients.3,4,5,6 FGFRs play
an important role in tumour 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.
About FIGHT-202
The FIGHT-202 is a multi-center,
open-label, single-arm, Phase 2 study (NCT02924376) that evaluated
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 FGFR2 fusion or
rearrangement.
Patients were enrolled into one of three cohorts – Cohort A (FGFR2
fusions or rearrangements), Cohort B (other FGF/FGFR genomic
alterations) or Cohort C (no FGF/FGFR genomic 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 was 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; and
duration of response (DOR).
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 the 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 tumour malignancies harbouring activating FGFR mutations or
translocations, irrespective of tumour type. FIGHT-205 is a Phase 2
study investigating pemigatinib plus pembrolizumab combination
therapy and pemigatinib monotherapy as first-line treatment for
metastatic or unresectable bladder cancer harbouring FGFR3
mutations or rearrangements who are not eligible to receive
cisplatin. FIGHT-302 is a Phase 3 study investigating
pemigatinib as a first-line treatment for patients with
cholangiocarcinoma with FGFR2 fusions or rearrangements.
About
Pemazyre® (pemigatinib)
Pemazyre
is a kinase inhibitor indicated for the treatment of adults with
previously treated, unresectable locally advanced or metastatic
cholangiocarcinoma with a fibroblast growth factor receptor 2
(FGFR2) fusion or other rearrangement.6
In the United States, Pemazyre
is approved for the treatment of adults with previously treated,
unresectable locally advanced or metastatic cholangiocarcinoma with
an FGFR2 fusion or other rearrangement as detected by an
FDA-approved test. This indication is approved under accelerated
approval based on overall response rate and duration of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial(s).
In Japan, Pemazyre is approved
for the treatment of patients with unresectable biliary tract
cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2)
fusion gene, worsening after cancer chemotherapy.
In Europe, Pemazyre is approved
for the treatment of adults with locally advanced or metastatic
cholangiocarcinoma with a fibroblast growth factor receptor 2
(FGFR2) fusion or rearrangement that have progressed after at least
one prior line of systemic therapy.
Pemazyre 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.
Pemazyre is marketed by Incyte in the
United States, Europe and
Japan. Incyte has granted Innovent
Biologics, Inc. rights to develop and commercialize pemigatinib in
hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Incyte has retained all other rights
to develop and commercialize pemigatinib outside of the United States.
Pemazyre is a trademark of Incyte.
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.
To learn more about Incyte Biosciences Canada, visit
https://incytebiosciences.ca.
Forward-Looking Statements
Except for the historical
information set forth herein, the matters set forth in this press
release, including statements regarding the FIGHT clinical trial
program and whether Pemazyre might provide a successful treatment
option for patients with previously treated, locally advanced or
metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements,
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 Canadian regulatory authorities or
other regulatory authorities, including 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; and other risks
detailed from time to time in the Company's reports filed with the
Securities and Exchange Commission, including its annual report for
the year ended December 31, 2020, and
the quarterly report on Form 10-Q for the quarter ended
June 30, 2021. The Company disclaims
any intent or obligation to update these forward-looking
statements.
_______________________________
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1
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Banales JM, et al.
Nat Rev Gastroenterol Hepatol. 2016;13:261‒280.
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2
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Uhlig J, et al. Ann
Surg Oncol. 2019;26:1993–2000.
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3
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Graham RP, et al. Hum
Pathol. 2014;45:1630‒1638.
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4
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Farshidfar F, et al.
Cell Rep. 2017;18(11):2780–2794.
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5
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Ross JS et al. The
Oncologist. 2014;19:235–242.
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6
|
Pemazyre® (pemigatinib) [Product
Monograph]. Wilmington, DE: Incyte; September 2021
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SOURCE Incyte Biosciences Canada