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
Clene Nanomedicine Partners with Veristat to Reduce Biostatistical Output Time by 80% for ALS New Drug Application12.11.2026 18:09:00 CET | Press release
Veristat’s InStat™ delivers submission-ready tables, listings, and figures (TLFs) in one week using validated statistical engines, shortening the critical path from database lock to submission VeristatTM, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced that it has partnered with Clene Nanomedicine to cut the time to deliver biostatistical outputs for a pivotal ALS drug application submission by 80%. Veristat reduced the time from study data to validated tables, listings and figures (TLFs) from up to six weeks to just one week. Clene, a late-stage biotech company, leveraged Veristat’s recently launched InStat™ platform, the industry’s first zero-code, fully automated solution to accelerate clinical trial processes. Biostatistical TLFs sit on the critical path for submissions, yet most sponsors rely on antiquated processes that involve slow, manual workflows to produce them, making post-database lock one of the biggest bottlenecks
WHOOP Launches WHOOP Humans, the Most Verifiably Human Social Network12.11.2026 18:00:00 CET | Press release
New feature lets members follow friends and family, share performance and health insights, and celebrate life's moments together WHOOP, the human performance brand, today launched WHOOP Humans, a new feature that lets members follow friends and family, share fitness, health, and performance data they choose, and support each other's progress. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112176779/en/ WHOOP Launches WHOOP Humans, the Most Verifiably Human Social Network For more than a decade, WHOOP has helped members better understand their own health and performance. Now, WHOOP Humans extends that experience beyond the individual, making it easier to celebrate achievements, encourage progress, and look out for the people who matter most. "In a world that's becoming increasingly artificial, we're building something deeply human,” said Will Ahmed, Founder and CEO of WHOOP. “This is the most verifiably human network ever
Integrated Hubs for Green Chemistry Research Aim to Transform How Chemicals and Materials Are Designed12.11.2026 17:00:00 CET | Press release
International network will investigate fundamental principles for creating safer, higher-performing chemicals and materials The Gordon and Betty Moore Foundation today announced four Integrated Research Hubs to explore new frontiers in chemical design, from materials that respond to their surroundings to molecules designed for safety from the start. Bringing together global researchers across institutions and disciplines, the hubs will investigate fundamental principles that could enable new capabilities in chemicals and materials while improving performance and protecting human health and the environment. The research priorities emerged through extensive engagement with the scientific community to identify the questions that could transform what chemistry can achieve. Each hub will connect researchers across institutions around one of four green chemistry focus areas: Safer molecular design: Led by The George Washington University, this hub will combine artificial intelligence and qua
Roquette Highlights Scalable Excipient and Capsule Solutions for Regional and Global Pharmaceutical Markets at CPHI India 202612.11.2026 16:00:00 CET | Press release
Helping pharmaceutical manufacturers accelerate the journey from formulation to market through deep technical expertise, meaningful innovation, close collaboration and global capabilities Roquette, a global leader in plant-based ingredients and a leading provider of pharmaceutical excipients, will showcase its comprehensive portfolio of excipient and capsule solutions at CPHI India 2026, Hall 1, Booth 1I12 from November 23 to 25, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112803410/en/ Meet Roquette at CPHI India 2026, Hall 1, Booth 1I12 At the event, Roquette will demonstrate how it helps pharmaceutical manufacturers accelerate the journey from formulation to market with confidence. By combining technical expertise, trusted quality, meaningful innovation and close collaboration, Roquette helps customers address formulation, scale-up and manufacturing challenges across a broad range of pharmaceutical application
Tigo Energy and Google Cloud Pair AI-Powered Tools for Solar Installers and Utilities12.11.2026 15:00:00 CET | Press release
The collaboration combines Tigo software with Google’s Gemini models on Google Cloud to help automate installer and utility operations for distributed energy portfolios. Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced a collaboration with Google Cloud to develop AI-enabled operational workflows for solar installers and distributed energy portfolios. By making core Tigo data and software products available through Google Cloud, Tigo aims to deliver faster deployment, simplified data integration, and additional insights with Gemini. The resulting workflows will help installers, asset managers, and energy operators more easily identify issues, prioritize actions, and automate routine operational tasks across growing fleets of distributed energy systems. As solar and storage portfolios expand, energy businesses are increasingly responsible for managing more sites, more system data, and more custo
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