Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Retifanlimab ...
February 26 2021 - 3:00AM
Business Wire
Incyte (Nasdaq:INCY) today announced the validation of the
Company’s Marketing Authorization Application (MAA) for
retifanlimab, an intravenous PD-1 inhibitor, as a potential
treatment for adult patients with locally advanced or metastatic
squamous cell anal carcinoma (SCAC) who have progressed on, or who
are intolerant of, platinum-based chemotherapy. The European
Medicines Agency’s (EMA) validation of the MAA confirms that the
submission is sufficiently complete to begin the formal review
process.
“While the incidence of SCAC is increasing in Europe, treatment
options for advanced disease are limited in their effectiveness,
and there are no approved options once patients have progressed on
standard therapy,” said Lance Leopold, M.D., Group Vice President,
Immuno-Oncology Clinical Development, Incyte. “The EMA validation
of the MAA for retifanlimab – which follows the recent U.S. Food
& Drug Administration acceptance of our Biologics License
Application for Priority Review – brings us closer to providing a
new option for patients in Europe with this rarely studied
tumor.”
The MAA is based on data from the Phase 2 POD1UM-202 trial
evaluating retifanlimab in previously treated patients with locally
advanced or metastatic SCAC who have progressed on, or are
intolerant of, standard platinum-based chemotherapy which were
presented at the 2020 virtual ESMO Congress.
SCAC is associated with human papillomavirus (HPV) and HIV
infections and accounts for almost 3% of digestive system cancers.1
In Europe, each year approximately 12,000 patients receive SCAC
diagnosis.2 Patients with metastatic SCAC have a poor 5-year
survival and there are no approved treatments for patients who
progress on platinum therapy.3
About POD1UM-202
POD1UM-202 (NCT03597295) is a global, open-label, single-arm,
multicenter, Phase 2 study evaluating retifanlimab in patients with
squamous cell anal carcinoma (SCAC) who have progressed on, or who
are intolerant of, platinum-based chemotherapy. Retifanlimab 500 mg
is administered intravenously every 4 weeks.
The primary endpoint is objective response rate (ORR) as
determined by independent central review using RECIST v1.1.
Secondary endpoints include additional measures of clinical benefit
‒ duration of response (DOR), disease control rate (DCR),
progression-free survival (PFS) and overall survival (OS); safety
and pharmacokinetics.
For more information about the study, please visit
https://clinicaltrials.gov/ct2/show/NCT03597295.
About POD1UM
The POD1UM (PD1 Inhibitor Clinical Program in Multiple
Malignancies) clinical trial program for retifanlimab includes
POD1UM-202, POD1UM-303 in SCAC along with and benchmarking studies
in endometrial cancer, Merkel cell carcinoma and other solid
tumors. A Phase 3 trial in NSCLC (POD1UM-304) is also enrolling, as
are studies in combination with epacadostat, pemigatinib, and other
development compounds in the Incyte portfolio.
About Retifanlimab
Retifanlimab (formerly INCMGA0012), an investigational
intravenous anti-PD1 antibody, is currently under evaluation in
registration-directed trials as a monotherapy for patients with
microsatellite instability-high endometrial cancer, Merkel cell
carcinoma and squamous cell anal carcinoma (SCAC); and in
combination with platinum-based chemotherapy for patients with
non-small cell lung cancer.
Retifanlimab has been granted Orphan Drug Designation by the
U.S. Food and Drug Administration (FDA) for the treatment of anal
cancer, and the Biologics License Application for retifanlimab has
been accepted for Priority Review.
In 2017, Incyte entered into an exclusive collaboration and
license agreement with MacroGenics, Inc. for global rights to
retifanlimab. In 2019, Incyte and Zai Lab announced a collaboration
and license agreement for the development and commercialization of
retifanlimab in Greater China.
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 about
whether or when the EMA may authorize retifanlimab for the
treatment of patients with squamous cell anal carcinoma (SCAC), the
potential of retifanlimab to provide a meaningful treatment for
patients with SCAC, the retifanlimab development program, and the
safety and efficacy of retifanlimab in patients with SCAC, 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 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-K for the year ending December 31, 2020. The Company
disclaims any intent or obligation to update these forward-looking
statements.
1 Ghosn M, et.al. Anal cancer treatment: current status and
future perspectives. World J Gastroenterol 2015;21:2294-2302. 2
Globocan 3 Glynne-Jones R, et al. Ann Oncol. 2014;25(suppl
3):iii10–iii20.
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version on businesswire.com: https://www.businesswire.com/news/home/20210226005125/en/
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Ela Zawislak +41 21 343 3113 ezawislak@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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