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
Sindre Zeiner-Gundersen Joins Joi Scientific12.2.2026 20:00:00 CET | Press release
Joi Scientific is pleased to welcome Sindre Zeiner-Gundersen as the company’s Advanced Plasma & Resonant Energy Physicist. Sindre will lead Joi’s scientific activities including all aspects of Joi’s science program. Sindre is a quantum physics expert who previously served as CEO/President of Nornec AS, a Norwegian consulting and engineering services company. Nornec has been a consultant to Joi since 2024. At Nornec, Sindre provided consulting and R&D services in the areas of advanced nuclear reactor simulations, process and plant optimization, carbon capture optimization, materials selection and radiation effects, custom reactor design, muon and neutron detector systems, muon and catalyzed fusion and Hydrogen Rydberg Matter research. An applied physicist with end‑to‑end expertise in energy‑carrier gases - ammonia, methanol, hydrogen - as well as a radiation instrumentation specialist with experience in process and equipment design across the ammonia/hydrogen value chain, Sindre has aut
Angelalign Technology Inc. (6699.HK) Says a Preliminary European Court Ruling on Certain Software Features Will Have Minimal Impact on Users12.2.2026 17:58:00 CET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel”) said a ruling by the Unified Patent Court of Düsseldorf, Germany that it preliminarily cease its use of certain software functions that automatically update treatment plans would have minimal impact on the orthodontists and patients who use its clear aligner products. The ruling applies to certain European countries and excludes Spain, Switzerland, United Kingdom and Ireland. Angel will launch iPlan for applicable European users, which is an upgrade feature that has the same reliability and more flexibility for users. Angel denies that the Live Now feature in its iOrtho treatment planning software infringes any valid patents of Align Technology Inc. (ALGN). Angel has already filed an opposition against the patent with the European Patent Office (EPO), arguing that the claimed invention is neither novel nor inventive over the prior art, and is seeking its permanent invalidation. Angel is confident it will overcome the first-instance, non-fi
Model ML Buys Captide to Give Financial AI Agents Citable Corporate Disclosure Data12.2.2026 17:43:00 CET | Press release
Deal follows AI workflow company’s $75m fundraise - one of the largest fintech Series As in history Model ML today announced the acquisition of Captide, the leading financial data layer that turns complex global corporate filings and disclosures into LLM-ready documents and data for AI agents. The acquisition, just weeks after the fintech raised $75m in funding from leading US and UK investors, expands Model ML’s AI workflow builder, enabling its AI agents to reliably retrieve, reason over, and cite global filings. Earlier in 2025, Model ML bought Flippr which added automated PowerPoint generation and verification agents to the platform. Founded in 2024 by Maurits Brinkman and Miquel Trafí Ruiz, Captide’s API takes SEC filings, earnings calls and more and structures them in a way AI models can easily and accurately understand at scale. Its platform already spans 2.5 million+ documents and supports 1 billion embeddings. By bringing Captide into Model ML, clients – including Big 4 accoun
i2c Named Finalist for Best Security or Anti-Fraud Development at Card & Payments Awards Middle East 202612.2.2026 15:00:00 CET | Press release
i2c’s AI-driven Fraud Risk Management solution recognized for delivering impactful results for Middle East clients i2c Inc., a global financial technology innovator, has been named a finalist in the Best Security or Anti-Fraud Development category at The Card & Payments Awards Middle East 2026. The region’s premier awards program recognizes organizations that deliver practical, high-impact innovations to strengthen payment security and protect customers in one of the world’s fastest-growing digital payments markets. i2c was recognized for its AI-driven Fraud Risk Management solution, embedded directly within its unified banking and payments platform and operating in real time at the point of transaction authorization—an increasingly critical capability as digital payments scale across Middle East markets. By evaluating risk at the moment a payment is initiated, rather than after funds are approved, the solution enables earlier detection of fraudulent activity while preserving approval
SLB Awarded Multiple Offshore Drilling Contracts by Mubadala Energy for Tangkulo Deepwater Development in Indonesia12.2.2026 14:00:00 CET | Press release
Contracts support offshore gas development with first gas targeted before end of 2028 Global energy technology company SLB (NYSE: SLB) has been awarded multiple offshore drilling services contracts by Mubadala Energy, the Abu Dhabi headquartered international energy company, for the Tangkulo natural gas deepwater development and associated exploration and appraisal drilling activities in the Andaman Sea, offshore Indonesia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260212809124/en/ The project will leverage SLB’s offshore and deepwater technologies, including real-time downhole monitoring, to reduce operational risk, improve well placement and strengthen project economics. Under the awards, SLB will work with Mubadala Energy to deliver integrated drilling and well services across the full well life cycle. The scope includes directional drilling, drilling fluids, cementing, wireline, slickline, coiled tubing, well testin
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