Business Wire

Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Retifanlimab as a Treatment for Patients with Squamous Cell Anal Carcinoma (SCAC)

Share

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.

Contact information

Media
Catalina Loveman
+1 302 498 6171
cloveman@incyte.com

Ela Zawislak
+41 21 343 3113
ezawislak@incyte.com

Investors
Christine Chiou
+1 302 274 4773
cchiou@incyte.com

About Business Wire

Business Wire
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

Coty Lands Industry First With Sustainability Certificate for Lancaster Sun Care Products21.4.2021 10:00:00 CEST | Press release

Coty Inc. (NYSE: COTY), one of the world’s leading beauty companies and the global leader in fragrances, today announced that Lancaster has become the first ever sun care brand awarded the prestigious C2C CertifiedMaterial Health Certificate at the Silver level from the Cradle to Cradle Products Innovation Institute. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210421005237/en/ (Photo: Business Wire) The award indicates that 100% of the ingredients in Lancaster Sun Sensitive collection –Lancaster’s first clean and vegan range, and its most environmentally friendly yet - meet the Institute’s strict criteria. In addition to recognizing the sustainable innovation behind the collection, the Certification serves as the foundation for further improving the sustainability and product safety of sun care products over time. Lancaster Sun Sensitive collection provides broad sun protection* targeting 100% of sun spectrum through a cl

The Climate Pledge Announces More Than 100 Signatories Committed to Achieving Net-Zero Carbon by 2040 or Sooner21.4.2021 09:01:00 CEST | Press release

Today, Amazon and Global Optimism announced that more than 100 companies have now signed The Climate Pledge. Among the 52 new signatories joining The Climate Pledge today are well-known brands including Alaska Airlines, Colgate-Palmolive, HEINEKEN, PepsiCo, Telefónica, and Visa. Pledge signatories in total generate more than $1.4 trillion in global annual sales and have more than 5 million employees across 25 industries in 16 countries—demonstrating the collective impact The Climate Pledge can have in addressing climate change. Signatories to The Climate Pledge agree to: Measure and report greenhouse gas emissions on a regular basis. Implement decarbonization strategies in line with the Paris Agreement through real business changes and innovations, including efficiency improvements, renewable energy, materials reductions, and other carbon emission elimination strategies. Neutralize any remaining emissions with additional, quantifiable, real, permanent, and socially beneficial offsets t

Shippeo Sustains Stellar Growth, Recognized in 2021 Gartner Magic Quadrant for Real-time Transportation Visibility Platforms21.4.2021 09:00:00 CEST | Press release

Shippeo, the European leader in real-time supply chain transportation visibility, has been recognized in the Gartner Magic Quadrant for Real-time Transportation Visibility Platforms 2021. The complimentary report is available at shippeo.com. Shippeo COO Lucien Besse is pleased to see the company’s market momentum being acknowledged. “We believe our recognition in the Magic Quadrant reflects upon our heavy investment in R&D and rapid deployment support over the past year as the pandemic stimulates unprecedented interest in RTTV solutions.” This interest has led Gartner to predict that, “by 2023, 50% of global product-centric enterprises will have invested in real-time transportation visibility platforms.” “We’re proud to have a market-leading visibility product and to have achieved strong growth with some of the highest customer recommendation rates,” adds Besse. The company has also developed the most accurate and reliable ETA in the industry while offering full GDPR compliance. The CO

Biometrics Experts and New Study Highlight How Behavioral Biometrics Supports Strict Regulation and Offers Better Data Privacy Protections21.4.2021 09:00:00 CEST | Press release

BehavioSec, the industry pioneer and technology leader for behavioral biometrics and continuous authentication, today announced new findings that organizations and consumers can feel more comfortable with wider use of behavioral biometrics to safeguard their online digital experiences and identities. Following a year of digital transformation on a societal level, the demand for better online user experience and a stronger level of digital identity protection has become essential. With a year when the world has seen a combination of personal data theft with new rulings and proposed legislation, like the EU Schrems II in July 2020 and the US National Biometrics Information Privacy Act in August [US Senators Merkley, D-OR and Sanders, I-VT], the need for expert guidance has never been higher. BehavioSec shares this research and a company milestone to highlight how behavioral biometrics can be adopted transparently with clear benefits, and in compliant fashion with comprehensive data prote

GE and Hitachi ABB Power Grids Sign Landmark Agreement to Reduce Environmental Impact in the Electrical Transmission Industry21.4.2021 09:00:00 CEST | Press release

GE Renewable Energy’s Grid Solutions business (NYSE: GE) and Hitachi ABB Power Grids Ltd. announced today a non-exclusive, cross-licensing agreement related to the use of an alternative gas to sulfur hexafluoride (SF6) used in high voltage equipment. This fluoronitrile-based gas mixture has a significantly reduced impact on the environment compared to SF6. Under this landmark agreement announced just before Earth Day 2021 between two global leaders in power technologies – both companies will share complementary intellectual property related to their respective SF6-free solutions. This will help accelerate the use of fluoronitrile-based eco-efficient insulation and switching gas in high-voltage equipment as an alternative to SF6. A recent EU Commission report concluded that fluorinitrile-based gas mixtures may be the only insulating and switching gas alternative to SF6 when space is a constraint. Today’s historic agreement paves the way for a standard SF6-free solution for high-voltage

SES Joins United Nations Global Compact Initiative, Accelerates Purpose-led ESG Programme in 202121.4.2021 08:50:00 CEST | Press release

SES today announced it has joined the United Nations Global Compact, the world’s largest corporate sustainability initiative, underscoring the company's purpose-led Environmental, Social and Governance (ESG) programme. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210420006272/en/ SES Joins United Nations Global Compact Initiative, Accelerates Purpose-led ESG Programme in 2021 (Photo: Business Wire) By committing to the UN Global Compact framework, SES is now firmly aligning its long-standing societal and environmental impact efforts to the company’s purpose – doing the extraordinary in space to deliver amazing experiences everywhere on earth – and delivering on its ambitions to provide cloud-enabled, satellite-based intelligent connectivity and to make a difference worldwide. The UN Global Compact is a corporate initiative that encourages both business and non-business organisations to establish and define strategies, poli

Australia Flexes Muscle in Talent War with Newest Immigration Program21.4.2021 07:30:00 CEST | Press release

The global battle for talent supercharged by the Covid-19 pandemic shows no signs of abating, with Australia sending out strong signals that it intends to succeed with its latest immigration offering under the Australia Global Business and Talent Attraction Taskforce. Under the purview of the taskforce, there is a fast-tracked visa program with a streamlined path to permanent residence for talented individuals. The Global Talent visa has been designed to grow Australia’s innovation and tech economies in a bid to boost economic recovery, enhance resilience, and drive competitiveness by attracting dynamic, highly skilled individuals to relocate to its safe shores. With no age limit or investment prerequisite, the only requirements for applicants are to be internationally recognized, prominent in their field, and able to provide evidence of outstanding achievements. The 10 future-focused target sectors are: Agri-food and AgTech, Energy, Health Industries, Defence, Advanced Manufacturing a

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