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
DEWA Signs Three Agreements With Global Partners During WETEX 202628.10.2026 15:50:00 CET | Press release
Dubai Electricity and Water Authority (DEWA) signed three agreements with leading global entities during the 28th Water, Energy, Technology and Environment Exhibition (WETEX 2026). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261028187355/en/ DEWA signs three agreements with global partners during WETEX 2026 (Photo: AETOSWire) In the presence of HE Saeed Mohammed Al Tayer, MD&CEO of DEWA, the agreements were signed by Hussain Lootah, Executive Vice President of Transmission Power at DEWA, and concluded through Moro Hub, a subsidiary of Digital DEWA, the digital arm of DEWA. Al Tayer said: “We are committed to strengthening our strategic partnerships with leading global organisations and leveraging the latest technologies, solutions and best practices. This enables us to enhance the efficiency, resilience and future-readiness of our critical infrastructure, while keeping pace with advancements in cyber security, digital tra
Ras Al Khaimah Signs Landmark Friendship Agreement & 10 MoUs during Historic High-Level Tour of South China28.10.2026 14:48:00 CET | Press release
His Highness Sheikh Saud bin Saqr Al Qasimi, UAE Supreme Council Member and Ruler of Ras Al Khaimah, witnesses the signing of a historic agreement between Ras Al Khaimah and Fujian Province, China, concluding a six-day China visit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261028878989/en/ His Highness Sheikh Saud bin Saqr Al Qasimi, UAE Supreme Council Member and Ruler of Ras Al Khaimah, witnessed the signing of a landmark agreement between Ras Al Khaimah and Fujian Province, alongside 10 Memoranda of Understanding between entities from the Emirate and their Chinese counterparts, reflecting a shared commitment to broadening cooperation and translating longstanding relations into meaningful opportunities for the future. (Photo: AETOSWire) Signed in Fuzhou, the agreement establishes a framework for strengthening economic, maritime and cultural ties, including cooperation in green supply chains, port logistics, sustainabl
Media Release: Further Up – Allianz Reaches Highest-Ever Brand Value of $30.7 Billion28.10.2026 14:08:00 CET | Press release
Interbrand’s Best Global Brands 2026 ranking: For the eighth consecutive year, Allianz is the world’s most valuable insurance brand and now ranks No. 26 among all brands.Financial performance and continuous brand management underpin brand strength, reflected in a record first-half 2026 operating profit.In 2026 Allianz helped deliver safe Winter Olympic and Paralympic Games in Milano Cortina, established a partnership with tennis player Jannik Sinner and founded the Allianz School for Life to foster financial literacy. A steady climb to a new high: For the eighth consecutive year, Allianz is the world’s most valuable insurance brand and has reached a record $30.7 billion in brand value, lifting it one place to No. 26 in Interbrand’s Best Global Brands 2026 ranking. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261028268225/en/ #1 Global Insurance Brand This 9% increase on 2025 further narrows the gap to the world’s most valu
Seoul Semiconductor Ends Need for Rare Earths in White LEDs28.10.2026 14:03:00 CET | Press release
Affiliate Seoul Viosys begins mass production of WICOP 3, which emits white light without rare earths from chips as small as 10 micrometers For three decades, white LEDs have depended on rare earth materials such as yttrium aluminum garnet (YAG) layered onto a blue LED chip (Figure 1). Seoul Viosys Co., Ltd. (KOSDAQ: 092190) today announced that it has broken that dependence. It has developed and begun mass producing a chip that emits white light without rare earths. The chip can be as small as 10 micrometers (µm). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261028475699/en/ Figure 1. New invention: white WICOP 3 (source: Seoul Semiconductor Co., Ltd.) Seoul Viosys and its parent company Seoul Semiconductor Co., Ltd. (KOSDAQ: 046890) opened the micro LED market with WICOP. WICOP is a chip architecture that eliminates the package altogether. Doing away with the package is widely regarded in the industry as a revolution in
Gurobi’s 2026 State of Mathematical Optimization Report Reveals Growing Convergence of AI and Optimization28.10.2026 14:00:00 CET | Press release
Survey finds GenAI use is on the rise as organizations embed optimization deeper into everyday operations. Gurobi Optimization, LLC, the leader in decision intelligence technology, today announced the release of its 2026 State of Mathematical Optimization Report. Based on a survey of 382 non-academic professionals across industries, the report examines how businesses are putting optimization to work, and how its use is evolving alongside other AI technologies. In a notable shift, 79% of respondents now use GenAI or large language models (LLMs) in their optimization work, up from 30% in 2025, with 37% using these tools systematically in their development workflows. Respondents see the greatest potential for this combined approach in code generation and debugging (68%), model formulation (67%), and natural-language interaction with optimization models (62%). Other key findings include: Optimization is becoming part of everyday operations: 52% of respondents say optimization supports ongo
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