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
Traxys Group Completes Acquisition of Carbomax AB Through the Purchase of 100% of Comax22.4.2026 12:01:00 CEST | Press release
Traxys S.à.r.l., a global trader and merchant in the metals and natural resources sectors, is pleased to announce that the previously announced acquisition of Comax2 AB - the holding company of Carbomax AB - from Investment Aktiebolaget Spiltan and the other shareholders of Comax2 AB has successfully closed. Traxys Group has now acquired 100% of the interests in Comax2 AB, making Carbomax AB a wholly owned subsidiary of Traxys Group. All required Swedish regulatory clearances including foreign direct investment and antitrust approvals have been obtained allowing the parties to finalize the transaction. Carbomax AB is a leading Swedish trading house and industrial operator specializing in ferroalloys, carbon products and briquettes. Through this acquisition, Traxys strengthens its presence in the Scandinavian market and reinforces its commitment to advancing sustainable steel production in the region. The combination of Traxys and Carbomax creates significant commercial, operational and
Reply Signs Strategic Collaboration Agreement with AWS to Accelerate AI-Driven Cloud Transformation2.4.2026 10:00:00 CEST | Press release
Reply [EXM, STAR: REY] announced today that it has signed a strategic collaboration agreement (SCA) with Amazon Web Services (AWS) to accelerate the adoption of cloud and artificial intelligence solutions across key international markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260402597802/en/ This strategic collaboration agreement further reinforces Reply’s commitment to enable organizations across industries to harness the full potential of cloud and artificial intelligence technologies. At the core of the SCA is a strong focus on Artificial Intelligence and Generative AI. Leveraging the deep expertise of its specialized companies - Comsysto Reply, Data Reply, Sense Reply, and Storm Reply - Reply supports organizations in designing and deploying enterprise-grade GenAI solutions, including agentic AI systems for autonomous workflows, domain-specialized models for vertical industries, and governance frameworks aligne
Bending Spoons renews tech scholarship for women with €100,000 commitment2.4.2026 09:11:00 CEST | Press release
Bending Spoons today opened applications for the 2026 edition of its Women in Computer Science Scholarship. The program offers twenty scholarships, each worth €5,000, to university students pursuing technology degrees across Europe and the United Kingdom. This year’s recipients will also be invited to a two-day networking event in Milan in October, fully covered by the company. The initiative is part of a broader set of programs Bending Spoons runs to recognize and support the next generation of technology talent, including merit-based scholarships, networking events, and student competitions. "The students of computer science today will define what the field looks like in the years ahead," said Eva Milenkovska, talent manager at Bending Spoons and lead of the scholarship initiative. "This scholarship is about recognizing the women who are pushing themselves to excel and to help shape the future of the industry." This is the fourth time Bending Spoons has offered this specific scholars
SecurityTech on the Rise: G+D Reports Strong Order Intake and High Resilience in 20252.4.2026 08:30:00 CEST | Press release
In fiscal year 2025, Giesecke+Devrient (G+D) reaffirmed its position as global leader in SecurityTech for mission-critical infrastructure. In a market where security is becoming essential for technological and societal stability, G+D demonstrates strong growth prospects. In 2025, G+D achieved a record order intake of €3.6 billion (+8%). Revenue increased to €3.2 billion (+1%), although exchange rate effects dampened growth. The key figures underscore the company's strong operational performance and profitability: Adjusted EBIT reached a new high of €211 million. The substantial free cash flow of €119 million provides additional leeway for future investments. With its equally strong segments – Digital Security, Financial Platforms and Currency Technology – G+D boasts a resilient portfolio that effectively cushions market volatility. The company's success reflects this strategic strength, combining technological depth, a global presence and operational reliability. G+D is making targeted
Bona Releases 2025 Sustainability Report2.4.2026 08:05:00 CEST | Press release
Bona®, a global, family-owned company that supplies products for installing, renovating, maintaining, and restoring premium floors, has published its 2025 Sustainability Report. The report outlines progress across Bona’s three sustainability pillars – Respect our Planet, Care for People, and Trusted Business – and highlights the continued integration of sustainability into all aspects of its operations. “Our business is built on extending the life of existing flooring materials and reducing the need for replacement,” says Lidija Broström, Interim Chief Executive Officer at Bona. “At Bona, we are making steady progress in reducing our impact while building a stronger foundation for the future. By working closely with our partners, we aim to drive meaningful change across our value chain and contribute to a more sustainable future.” In 2025, Bona reduced total Scope 1 and 2 greenhouse gas emissions (market-based) by 46% compared to its 2022 baseline, reaching 1,338 tonnes of CO₂—surpassi
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