Incyte to Present Late-Breaking Phase 3 Results for Retifanlimab (Zynyz ® ) and Initial Data from Phase 1 CDK2 Inhibitor Program at the European Society of Medical Oncology (ESMO) Congress 2024
21.8.2024 18:40:00 EEST | Business Wire | Press release
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240821420609/en/
Contacts
Media
media@incyte.com
Investors
ir@incyte.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
www.businesswire.com
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
Sharjah Unveils Uruk: A New Generation of Sustainable Cities Built for the Post-AI Era29.10.2026 20:15:00 EET | Press release
In the presence of His Highness Sheikh Dr. Sultan bin Mohammed Al Qasimi, Supreme Council Member and Ruler of Sharjah, and Her Highness Sheikha Bodour bint Sultan Al Qasimi, President of American University of Sharjah and Chairperson of Sharjah Research, Technology and Innovation Park, a pioneering model for a new generation of cities designed for the post-AI era called “Uruk.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261029129346/en/ H.H. Sheikh Dr. Sultan bin Mohammed Al Qasimi, Ruler of Sharjah, during the inauguration of “Uruk” (Photo: AETOSWire) The project was revealed at the opening of the second edition of Sharjah Next, through a strategic partnership between Sharjah Research, Technology and Innovation Park (SPARK), American University of Sharjah (AUS) and SEE Holding, bringing together their capabilities in innovation, scientific research and sustainable urban development. Uruk introduces a new vision for urba
Motive and Vivo Brazil Win 2026 Leading Lights Award for Network API Monetization29.10.2026 18:35:00 EET | Press release
Motive, a global leader in entitlement, connected device and service management and Vivo Brazil, Brazil’s largest operator and part of the Telefónica Group, have won the 2026 Light Reading Leading Lights Award for Outstanding Use Case: Network API Monetization for the first commercial scale deployment of SIM-based silent authentication in Latin America. SMS OTP remains relevant as an authentication method due to its broad reach, working on virtually any type of mobile device. SIM-based silent authentication takes this experience a step further by eliminating the need to receive and manually enter codes. The result is a simpler, more seamless user journey that reduces friction and can help lower abandonment rates while increasing customer conversion and retention. Using Motive’s CAMARA-compliant Entitlement Server, Vivo can now verify a subscriber’s phone number directly without requiring a passcode over mobile networks. The business value is straightforward: a simpler authentication ex
REV Ocean Appoints Paul Baribault as CEO Ahead of 2027 Global Operations29.10.2026 16:45:00 EET | Press release
REV Ocean has appointed Paul Baribault as Chief Executive Officer as the organization moves towards the international debut of its 195-metre research vessel in Rio de Janeiro in April 2027, alongside the UN Ocean Decade Conference. One of the world's largest privately owned research and exploration vessels, REV represents a major philanthropic investment in ocean science. With nine laboratories, advanced deep-sea exploration vehicles and dedicated collaboration facilities, it is designed to give scientists access to world-class research infrastructure and connect their discoveries with the people and institutions able to drive ocean protection. Baribault joins as REV Ocean moves from a decade of engineering and construction into international operations. His mandate will be to build the international partnerships, funding base and organization needed to turn REV Ocean’s scientific capabilities into lasting ocean impact. An experienced conservation and nonprofit leader, Baribault served
Holder Partners Launches Strategic Communications Practice and Appoints Ali Ponte as Director and Practice Lead29.10.2026 16:15:00 EET | Press release
Holder Partners, a multidisciplinary consulting and advisory firm, today announced the launch of its Strategic Communications practice and the appointment of Ali Ponte as Director and Practice Lead. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261027701219/en/ Ali Ponte, Director and Practice Lead of Holder Partners’ Strategic Communications practice. The practice advises leading companies and institutions, their boards, senior executives and counsel on communications, reputation and stakeholder considerations in complex matters and periods of significant change or opportunity. Each engagement is tailored to the client’s objectives and, where relevant, draws on Holder Partners’ broader advisory capabilities. Its strategic counsel, informed by research and analysis, helps clients assess the implications of a matter, anticipate stakeholder responses and communicate clearly and effectively. That work includes crisis preparedn
Accertify Formalizes Partner Ecosystem as Fraud, Payments, and Chargebacks Converge Into a Single Risk Surface29.10.2026 16:00:00 EET | Press release
Accertify, a leading fraud decisioning provider whose Predictive Yes Platform helps merchants say yes to more good customers, more revenue, and more growth, today announced the launch of the Accertify Partner Program, a formalized partnership ecosystem connecting payment providers, orchestrators, commerce platforms, and consultancies to Accertify’s network-powered fraud intelligence. Partners can join through two tracks. The Referral track lets partners make a single introduction while Accertify handles the sale, implementation, and support. The Reseller track lets partners sell Accertify on their own contract and own the client relationship and margin. Partners that integrate with Accertify follow a defined certification path, so clients get a tested, supported connection from day one. Every client a partner brings joins a consortium where good customers verified anywhere in the network get through faster everywhere, and bad actors seen anywhere are stopped everywhere. In 2025, Accert
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