DE-INCYTE
Incyte (Nasdaq: INCY) today announced that the Company will present key data from its oncology portfolio at the upcoming European Society of Medical Oncology (ESMO) Congress 2024, to be held September 13-17 in Barcelona and virtually.
"The data at ESMO underscore the progress across our oncology portfolio and the potential to impact patients where additional treatment options are needed. Notably, a Presidential Symposium will feature new, pivotal results from the Phase 3 POD1UM-303/InterAACT2 study of retifanlimab (Zynyz®) for the treatment of squamous cell anal carcinoma (SCAC). The POD1UM-303 data will support the supplemental Biologics License Application (sBLA) filing for retifanlimab in SCAC planned by year end 2024," said Pablo Cagnoni M.D., President, Head of Research and Development, Incyte. "We will also present new data on INCB123667, a potential first-in-class CDK2 inhibitor, which we believe has the potential to enhance outcomes and serve as a foundational treatment for platinum-resistant ovarian and other cancers."
Details on the abstracts accepted for presentation at ESMO include:
Presidential Symposium
Retifanlimab (PD-1)
POD1UM-303/InterAACT2: Phase 3 Study of Retifanlimab With Carboplatin-Paclitaxel (C-P) in Patients (Pts) With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal (SCAC) Not Previously Treated With Systemic Chemotherapy
Presidential Symposium I: Practice-changing trials. Presentation Number: LBA2. Presentation Time: 10:50-11:02 a.m. ET (4:50-5:02 p.m. CET), September 14, 2024
Mini Oral Session
INCB123667
Safety and Tolerability of INCB123667, a Selective CDK2 Inhibitor, in Patients (Pts) With Advanced Solid Tumors: A Phase 1 Study
Mini oral session: Developmental therapeutics. Presentation Number: 617MO. Presentation Time: 9:35 – 9:40 a.m. ET (3:35-3:40 p.m. CET), September 14, 2024
Conference Call and Webcast
Incyte will host an in-person analyst and investor event on Saturday, September 14, 2024, from 1:00-2:30 p.m. ET (7:00-8:30 p.m. CEST) to discuss key data presentations at ESMO including data from the POD1UM-303 Presidential Symposia and its CDK2 inhibitor program. The CDK2 data presentation will include new results from a later data cut-off, as well as the data included in the ESMO accepted abstract and mini-oral presentation. The event will be webcasted and can be accessed via the Events and Presentations tab of the Investor section of Incyte.com and it will be available for replay for 90 days.
Conference call details will be provided on the Investor section of Incyte.com.
Abstracts will be available to registered attendees on the ESMO Virtual Congress platform beginning on September 9, 2024. All accepted abstracts will be published in the ESMO Congress 2024 Abstract Book, a supplement to the official ESMO journal, Annals of Oncology.
More information regarding the 2024 ESMO Congress can be found at https://www.esmo.org/meeting-calendar/esmo-congress-2024.
About Retifanlimab (Zynyz®)
Retifanlimab (Zynyz®), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.
Zynyz is a trademark of Incyte.
About Incyte
A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.
For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.
Incyte Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s clinical development pipeline, the potential for retifanlimab and INCB123667 to positively impact patients and plans to submit an sBLA for retifanlimab in SCAC by year end 2024, contain predictions, estimates, and other forward-looking statements.
These forward-looking statements are based on our current expectations and are 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 and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA and regulatory agencies outside of the United States; the efficacy or safety of our products; the acceptance of our products in the marketplace; market competition; unexpected variations in the demand for our products and the products of our collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for our products; sales, marketing, manufacturing, and distribution requirements, including our ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional new products that become approved; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended June 30, 2024. We disclaim any intent or obligation to update these forward-looking statements.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240821420609/en/
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
Estée Lauder Announces Actress Daisy Edgar-Jones as Newest Global Brand Ambassador8.1.2026 14:00:00 CET | Press release
Estée Lauder today announced that it has signed acclaimed British actress, Daisy Edgar-Jones, as its newest Global Brand Ambassador. Daisy will represent Estée Lauder skin care, makeup, and fragrance, with her first campaign debuting on February 2nd across print, digital and in-store. She joins Estée Lauder’s current roster of global talent including Ana de Armas, Bianca Brandolini, Carolyn Murphy, Imaan Hammam, IU, Karlie Kloss, Paulina Porizkova and Yang Mi. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260108459289/en/ Daisy Edgar-Jones for Estée Lauder “As an actress, I love how makeup can tell a story of who we are. I have always admired how Estée Lauder celebrates confidence and individuality in women. The legacy, elegance, and strength of the brand is so inspiring,” said Daisy Edgar-Jones. “It feels surreal to be part of the Estée Lauder family – and it truly feels like a family.” “Daisy is very much the breakout sta
Kinaxis Appoints Razat Gaurav as New CEO8.1.2026 14:00:00 CET | Press release
With over two decades of supply chain experience and a proven record of driving global growth Razat Gaurav is uniquely positioned to lead Kinaxis in its next phase of AI-driven innovation. Kinaxis® Inc. (TSX:KXS), a global leader in supply chain orchestration, today announced the appointment of Razat Gaurav as Chief Executive Officer (CEO) effective January 12, 2026, his official start date, at which time he will also join the Kinaxis Board of Directors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260108330975/en/ Razat Gaurav, Kinaxis CEO “After a rigorous search, the Board selected Razat to lead the company as CEO,” said Bob Courteau, Interim CEO and Board Chair at Kinaxis. “Razat’s twenty-five years of experience in supply chain solutions, his proven track record in advancing innovation-driven growth, and his passion for developing high-performing cultures make him uniquely qualified for this role. The Board looks forw
Liberty Latin America Expands Exclusive International Voice Managed Services Partnership with BTS to 22 Additional Caribbean Markets8.1.2026 13:30:00 CET | Press release
BTS, the leading provider, technology enabler, and trusted partner to CommTech players worldwide, has been appointed by Liberty Latin America (LLA) as the exclusive provider of International Voice Managed Services for 22 additional Caribbean markets. This expansion builds on the successful 2023 partnership, in which BTS was selected as the exclusive international voice provider for Costa Rica, Panama, Puerto Rico, and the U.S. Virgin Islands. With this agreement, BTS will now support International Long Distance (ILD) services across a total of 26 LLA markets. Effective January 1, 2026, BTS began handling ILD voice services for the newly added Caribbean markets, enabling greater service consistency, enhanced quality, and improved operational efficiency across LLA’s regional footprint. The 22 new markets incorporated under the expanded partnership include: Anguilla, Antigua, Bahamas, Barbados, Bonaire, British Virgin Islands, Cayman, Curaçao, Dominica, Grenada, Jamaica, Montserrat, Saba,
Det-Tronics Acquires Optronics8.1.2026 13:28:00 CET | Press release
Optronics is a global leader in optical gas detection products and solutions for high-hazard, mission-critical applications Det-Tronics, a global leader in fire and gas safety systems, has acquired Optronics, a Norway-based company that specializes in optical gas detection technologies. Det-Tronics is part of Spectrum Safety Solutions that is based in Stamford, CT. Optronics, founded in 2018, is a technology leader in high-end optical gas detection products and solutions for energy, marine and industrial applications. Optronics has a strong record of innovation, bringing leading products and expert solutions to market for its customers. (www.optronics-technology.com) “Det-Tronics’ strategy is built on growth, innovation and quality. Optronics and Det-Tronics are a perfect fit to grow our businesses, drive new innovations and lead the market with high quality and reliable products and solutions,” noted Johannes Mario Kahlert, President of Det-Tronics. “We are very excited for the path a
Virometix AG Announces Positive Data from Phase 1 Trial of V-212, a Fully Synthetic, Serotype-Independent Vaccine Development Candidate for the Prevention of Pneumococcal Disease8.1.2026 13:00:00 CET | Press release
V-212 was well tolerated and demonstrated an excellent safety profileRobust IgG responses were observed to all three antigens in the vaccineResults support further development of V-212 independently and in combination with approved pneumococcal conjugate vaccines (PCVs) Virometix AG, a clinical-stage biotechnology company pioneering fully synthetic vaccines, today announced positive topline data from the Company’s Phase 1 trial of its lead asset V-212, a serotype-independent pneumococcal vaccine candidate, in development for the prevention of pneumococcal disease caused by Streptococcus pneumoniae (Spn) infections. The study evaluated safety and immunogenicity in healthy volunteers, with data demonstrating an excellent safety profile and robust immune responses across all three target antigens in the vaccine. Results support further development of V-212 independently and in combination with an approved PCV. “With the significant need for an effective serotype-independent vaccine, we ar
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