Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy.
The BLA submission 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. The trial enrolled 94 patients, including several with well-controlled human immunodeficiency virus (HIV) infection. The study, which was recently presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, resulted in an objective response rate (ORR) of 14% for retifanlimab monotherapy as determined by independent central review (ICR) using RECIST v1.1. Responses were observed regardless of PD-L1 status, presence of liver metastases, age or HIV+ status and were durable (median 9.5 months). Treatment-related adverse events ≥Grade 3 occurred in 11.7% of patients. Immune-related adverse events ≥Grade 3 occurred in 6.4% of patients. The most common adverse reactions (incidence ≥ 20%) were fatigue and diarrhea.
“Patients with SCAC who have progressed after first-line chemotherapy treatment currently have no approved treatments available, and we are encouraged that the FDA’s acceptance of this BLA for Priority Review brings us one step closer to addressing this historically neglected, yet important, tumor,” said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte. “Despite SCAC being a rare disease, its incidence is increasing and its impact is profound. We look forward to working with the FDA to potentially fill an unmet need and advance progress in SCAC for patients.”
Retifanlimab has been granted Orphan Drug Designation by the FDA for the treatment of anal cancer, along with Priority Review. 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 by four months as compared to Standard Review. The Prescription Drug User Fee Act (PDUFA) target action date for retifanlimab is July 25, 2021.
SCAC is associated with human papillomavirus (HPV) and HIV infections and accounts for almost 3% of digestive system cancers.1 Patients with metastatic SCAC have a poor 5-year survival, and there are no FDA-approved treatments for patients who have progressed after first-line chemotherapy.2
POD1UM-303/InterAACT 2 (NCT04472429), a Phase 3 trial of retifanlimab in combination with carboplatin and paclitaxel in patients with inoperable locally recurrent or metastatic SCAC, is now open and recruiting patients.
About POD1UM-202
POD1UM-202 (NCT03597295) is an open-label, single-arm, multicenter, Phase 2 study evaluating retifanlimab in patients with squamous cell carcinoma of the anal canal (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 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-202, POD1UM-303 and several other Phase 1, 2 and 3 studies for patients with solid tumors including squamous cell carcinoma of the anal canal (SCAC), microsatellite instability-high endometrial cancer, Merkel cell carcinoma and non-small cell lung cancer, among others.
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 carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.
Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.
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 FDA may approve retifanlimab for the treatment of patients with squamous cell carcinoma of the anal canal (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 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 ended September 30, 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 Eng C, et al. The role of systemic chemotherapy and multidisciplinary management in improving the overall survival of patients with metastatic squamous cell carcinoma of the anal canal. Oncotarget 2014;5:11133-11142.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210121005917/en/
Contact information
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
Christine Chiou +1 302 274 4773
cchiou@incyte.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Transition Industries Signs Strategic Agreements for the Pacifico Mexinol Project, the Largest Standalone Ultra-Low Carbon Chemical Production Facility in the World30.6.2025 21:30:00 EEST | Press release
Transition Industries LLC, a developer of world-scale, net-zero carbon emissions methanol and green hydrogen projects in North America, held a signing event for an Engineering, Procurement, and Construction (EPC) contract with the consortium of Samsung E&A Co., Ltd. (Samsung E&A), Grupo Samsung E&A Mexico, S.A. de C.V., and Techint Engineering and Construction for the Pacifico Mexinol project located in Ahome, Sinaloa, Mexico, which is contingent upon the fulfillment of customary conditions precedent and obtainment of all required approvals. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630940954/en/ MAIRE group’s technology division NextChem, through its subsidiary KT TECH SpA, also signed a Basic Engineering, Critical and Proprietary Equipment Supply Agreement with Samsung E&A in connection with its proprietary NX AdWinMethanol®Zero technology supply to the project. Transition Industries is jointly developing the Pacif
Westinghouse and ITER Sign a $180M Contract to Advance Nuclear Fusion30.6.2025 16:45:00 EEST | Press release
Westinghouse Electric Company and ITER signed a contract for $180 million for the assembly of the vacuum vessel for the fusion reactor. This is a key milestone in the construction of the ITER reactor, leading the way toward the use of fusion as a practical future source of reliable carbon-free energy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630497810/en/ The ITER Tokamak pit with the two vacuum vessel sector modules installed. Westinghouse has participated in the fabrication of the sectors of the vacuum vessel, as part of the Fusion for Energy (F4E) Consortium with its partners Ansaldo Nucleare and Walter Tosto. Westinghouse will be responsible for completing the vacuum vessel which is ITER’s most critical component: a hermetically sealed, double-walled steel container that will house the fusion plasma. When all the vacuum vessel sectors are in place, Westinghouse will start the most intensive stage of ITER assembl
Monetate Acquires SiteSpect to Deliver AI-Native Personalization and Testing at Enterprise Scale30.6.2025 16:00:00 EEST | Press release
Monetate, the leading AI-driven personalization platform, today announced it has acquired SiteSpect, a leader in A/B testing, to drive next-generation digital experience optimization. This acquisition accelerates Monetate’s vision to deliver intelligent, intentional, and individualized experiences at scale, powered by agentic AI and backed by the industry’s most advanced, enterprise-grade infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630514541/en/ The combination of Monetate’s real-time personalization and SiteSpect’s zero-flicker testing will yield an industry-first solution for enterprise-grade personalization, testing, and optimization. For the first time, global ecommerce and digital experience leaders can access unified client-side and server-side experimentation with full personalization capabilities in a single solution, designed for scalability and regulatory compliance. Monetate is now the only e
SS&C Blue Prism Recognized as a Gartner® Magic Quadrant™ RPA Leader for the Seventh Consecutive Year30.6.2025 16:00:00 EEST | Press release
SS&C Technologies Holdings, Inc. (Nasdaq: SSNC) today announced that SS&C Blue Prism has been recognized as a Leader in the 2025 Gartner Magic Quadrant for Robotic Process Automation (RPA). “We’re delighted SS&C Blue Prism has been named a Leader in the Gartner Magic Quadrant for Robotic Process Automation for the seventh year running,” said Bill Stone, CEO and Chairman of SS&C Technologies. “SS&C Blue Prism combines market-leading RPA and orchestration technologies with the latest artificial intelligence so organizations can tackle more complex tasks and dynamic business processes. We’ve scaled to more than 2,700 digital workers and AI agents across our own operations, resulting in over $200 million in annual savings. With SS&C leading the charge on deployment, customers can be confident in rolling out SS&C’s automation solutions securely, effectively, and responsibly.” More than 2,800 companies worldwide leverage SS&C Blue Prism for AI-powered automation, helping organizations delive
Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content 130.6.2025 15:00:00 EEST | Press release
Takeda(TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with less than or equal to 2 µg/mL IgA in a 10% solution, the only ready-to-use liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content, as replacement therapy for people two years of age and older with primary immunodeficiency (PI). As a ready-to-use liquid, GAMMAGARD LIQUID ERC may help ease the administration burden for patients and their health care providers by eliminating the need for reconstitution and can be administered intravenously or subcutaneously.1 “The approval of GAMMAGARD LIQUID ERC reinforces our commitment to supporting individualized treatment approaches for people with primary immunodeficiency, including a therapeutic option that has the lowest IgA content of any ready-to-use liquid immunoglobulin therapy, and can be administered intravenously or subcutaneously,” said Kristina Allikmets, s
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom