DE-INCYTE
26.2.2021 09:02:05 CET | Business Wire | Press release
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210226005125/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
Strategic Combination of ITC Infotech and Happiest Minds Technologies to Create a Scaled, Future-Ready, AI-First Global Technology Services Enterprise with US$ 1 Billion Revenue by FY28[1]31.8.2026 23:35:00 CEST | Press release
ITC Infotech Board approves proposed acquisition of 22.1% promoter stake and a Scheme of Amalgamation of the two companies ITC Infotech (ITCI), a wholly owned subsidiary of ITC Limited and a leading global technology services player, today announced the proposed strategic combination with Happiest Minds Technologies Limited (Happiest Minds) to create a scaled, future-ready, AI-first global technology services enterprise. The ITCI Board approved a proposal to acquire 22.1% equity stake from the promoter of Happiest Minds in two tranches under a Share Purchase Agreement. The transaction would be funded through a Rights Issue by ITC Infotech. ITCI Board has also approved a proposed Scheme of Amalgamation of Happiest Minds with ITCI which will be effected after the share acquisition. Pursuant to the scheme, the shares of ITCI will be listed on the stock exchanges. The proposed transaction has also been endorsed by the Board of Directors of ITC Limited. This strategic combination will syner
Angel’s Profits Grew Robustly in the First Half of 2026 with Europe and North America Turning Profitable Ahead of Schedule31.8.2026 21:07:00 CEST | Press release
Angelalign Technology Inc. (“Angel” or the “Company”) (6699.HK) (angelaligner.com), the second largest clear aligner supplier by revenue, announced today that its revenue grew 42.9% to US$230.7 million and net profit grew 79.6% to $25.5 million for the six months ending June 30, 2026. Angel’s business in Europe and North America crossed into profitability ahead of plan while the business in Chinese mainland delivered market share gains well above expectations. Doctors and staff in every region report that they are increasingly selecting Angel’s solutions after experiencing more predictable outcomes, especially on complex cases, and embracing the positive culture of the company. Dr. Mark Holt D.D.S., M.S. of Holt Orthodontics in Northern California, states: “We treat over half of our patients with clear aligners and our experience with Angel’s treatment plans and clear aligners has been tremendous.” “Our main focus is to provide great service to and being a rock-solid partner for our cu
BeOne Medicines Announces Voluntary Agreement with U.S. Government to Expand Access to Innovative Cancer Medicines31.8.2026 21:00:00 CEST | Press release
Agreement advances patient access and strengthens BeOne's long-term commitment to U.S. innovation and manufacturing BeOne Medicines, Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced a voluntary agreement with the U.S. Government to expand access to innovative cancer medicines for American patients while strengthening our U.S manufacturing footprint and further expanding the capabilities needed to deliver medicines at scale. The agreement builds on BeOne's longstanding commitment to patient access and investment in research and scientific innovation. John V. Oyler, Co-Founder, Chairman and CEO, BeOne Medicines, said: “At BeOne, we believe every patient should benefit from innovative cancer therapies. We appreciate the Trump Administration’s commitment to advancing solutions that broaden access and scientific progress for American patients. This agreement reflects our purpose to reach more patients as we expand our U.S. investment in additional res
MEX Exchange, Part of MultiBank Group, Announces Senior Leadership Appointments31.8.2026 15:36:00 CEST | Press release
David Ogg appointed Vice Chairman and Brian Andreyko named CEO MEX Exchange, the institutional electronic trading platform of MultiBank Group, has announced two senior leadership appointments, with David Ogg promoted to Vice Chairman and Brian Andreyko promoted to Chief Executive Officer. The appointments strengthen the company’s leadership as it advances the development of its institutional electronic trading platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260831401493/en/ MEX Exchange, part of MultiBank Group, Announces Senior Leadership Appointments with David Ogg appointed Vice Chairman and Brian Andreyko named CEO. David Ogg brings more than four decades of experience in foreign exchange trading and trading technology and is widely recognised within the institutional FX industry as the “Father of the ECN.” He founded HotspotFX in 1999, the first institutional FX electronic communications network, before going o
Rimini Street Announces Stock Repurchase and Debt Reduction Transactions31.8.2026 15:00:00 CEST | Press release
The Company recently completed an additional $5.0 million of common stock repurchases and $5.0 million of debt prepayment that brings total fiscal year-to-date capital return and balance sheet optimization to $30.9 million Rimini Street, Inc., (Nasdaq: RMNI), a global provider of end-to-end enterprise software support, managed services and Agentic AI ERP innovation solutions, and the leading third-party support provider for Oracle, SAP and VMware software, today announced additional, recent capital return and balance sheet optimization actions as noted below during the fiscal third quarter through August 28, 2026: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260831961587/en/ Rimini Street Announces Stock Repurchase and Debt Reduction TransactionsDebt Reduction: The Company prepaid $5.0 million of its term loan and has reduced term loan debt by a total of $25.9 million fiscal year-to-date, reducing the outstanding balance t
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