DE-INCYTE
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210121005917/en/
Link:
About Business Wire
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
Year-old European startup Maisa named alongside Google and Amazon in elite list of leading AI agent vendors in top global US research reports by Gartner3.7.2025 01:01:00 CEST | Press release
- First time a Spanish startup has made the list, thanks to its industry-first hallucination resistant ‘digital workers’ - AI startup is one of two European AI agent vendors in Gartner’s Hype Cycle report for Artificial Intelligence and Hype Cycle for the Future of Work lists Maisa, a rising star of enterprise AI, has been named by leading global research and advisory firm Gartner in its list of leading vendors for developing reliable AI agents. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702640749/en/ Maisa founders David Villalón and Manuel Romero Inclusion in Gartner’s 2025 Hype Cycle for AI and Hype Cycle for the Future of Work marks the first time a Spanish startup has been mentioned in these influential reports. The company, which is barely a year old and made its first raise of $5m+ from leading US investors last year, now finds itself named alongside global giants Amazon Web Services, Google, Salesforce and Lan
Hoffmann Green Announces a Historic Increase in Production Over the First Half of 2025, Already Outperforming the Annual Volumes Realized in 20242.7.2025 19:05:00 CEST | Press release
Record activity levels: +151% increase in production volumes in H1 2025 vs. H1 2024More than 130 construction sites supplied with more than 60,000 m³ of 0% clinker concrete delivered by 10,000 truck mixers across the countryAcceleration driven by a strengthened partnership network and the successful diversification of targeted marketsSolid outlook for the second half of 2025, in line with the strategic roadmap Hoffmann Green Cement Technologies (ISIN: FR0013451044, Ticker: ALHGR) (“Hoffmann Green Cement” or the “Company”), an industrial player committed to the decarbonation of the construction sector that designs and markets innovative clinker-free cements, today announces a strong acceleration of production over the first half of 2025, validating the relevance of its industrial and commercial business model. Production volumes reached 19,640 tonnes over the first half of 2025, compared with 7,833 tonnes in the first half of 2024, representing a 2.5-fold increase. This very strong leve
Institutional Real Estate, Inc. Announces Acquisition of U.K.-based Lyndon Publishing 2 Limited2.7.2025 18:44:00 CEST | Press release
Institutional Real Estate, Inc. (“IREI”) has completed its acquisition of the assets of London-based Lyndon Publishing 2 Ltd (“Lyndon Publishing”), which include The Property ChronicleandThe Green Chronicle.The former Lyndon Publishing 2 will now operate as a division of IREI. The Property Chronicle reaches a global audience of real estate investment professionals, researchers, and academics. Its sister publication, The Green Chronicle, is edited to address the interests and concerns of emerging young talent in these real estate professions. Both publications are produced as weekly news briefings filled with original content and contributed feature articles from industry thought and opinion leaders. In addition, The Property Chronicle is also published as a quarterly, illustrated full-color magazine available in both digital and print formats, while The Green Chronicleis published exclusively in digital format. Together, the two publications reach approximately 50,000 professionals acr
Sinopec Wins Technological Innovation Award at 2nd Sino-European Corporate ESG Best Practice Conference2.7.2025 18:21:00 CEST | Press release
China Petroleum & Chemical Corporation ("Sinopec", HKG: 0386) has won the "Best Scientific and Technological Innovation Practice" award at the 2nd Sino-European Corporate ESG Best Practice Conference (the "Conference") on June 26 in Stuttgart. Sinopec’s case submission of Breakthrough in Depth, Climb to New Heights — Empowering the Energy and Chemical Industry with Technological Innovation stood out among numerous entries. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702387465/en/ Wang Tao, Sinopec representative, delivered a speech at the conference. The Conference reviews and awards the best ESG application cases in six areas of environmental protection, social responsibility, corporate management, scientific and technological innovation, education, and training to further enhance mutual understanding between Chinese and European businesses, facilitate bilateral economic and trade exchanges, and showcase China’s open,
Xsolla Releases Their Q2 2025 The State of Play Report: Mobile Gaming Is Projected to Hit $126B in 2025 Amid Global App Boom With In-Depth Analysis of Trends, Genres, and Monetization Strategies2.7.2025 18:00:00 CEST | Press release
Key Topics Include In-App Purchase Trends, Genre Performance, Player Demographics, D2C Strategy Adoption, and Hybrid Monetization Models Xsolla, a leading global video game commerce company, proudly announces the release of the Q2 2025 Edition of “The Xsolla Report: The State of Play.” This detailed report provides crucial insights, trends, and opportunities shaping the gaming landscape, empowering industry professionals to adapt and thrive in today’s rapidly changing market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702208715/en/ Graphic: Xsolla In 2024, global mobile app usage soared to an astonishing 4.2 trillion hours, an all-time high that powered a massive $150 billion consumer spending across mobile platforms. Mobile gaming is leading this charge, which accounted for more than half of that total. Despite a 6% dip in overall game downloads, falling to 49.6 billion, in-app purchase (IAP) revenue surged, indicati
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