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
Clene Nanomedicine Partners with Veristat to Reduce Biostatistical Output Time by 80% for ALS New Drug Application12.11.2026 19:09:00 EET | Press release
VeristatTM, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced that it has partnered with Clene Nanomedicine to cut the time to deliver biostatistical outputs for a pivotal ALS drug application submission by 80%. Veristat reduced the time from study data to validated tables, listings and figures (TLFs) from up to six weeks to just one week. Clene, a late-stage biotech company, leveraged Veristat’s recently launched InStat™ platform, the industry’s first zero-code, fully automated solution to accelerate clinical trial processes. Biostatistical TLFs sit on the critical path for submissions, yet most sponsors rely on antiquated processes that involve slow, manual workflows to produce them, making post-database lock one of the biggest bottlenecks to regulatory approval. To remove this barrier, Veristat uses its AI-enhanced platform to compress the timeline to submission-ready TLFs from weeks to days, with every output validated by stati
WHOOP Launches WHOOP Humans, the Most Verifiably Human Social Network12.11.2026 19:00:00 EET | Press release
WHOOP, the human performance brand, today launched WHOOP Humans, a new feature that lets members follow friends and family, share fitness, health, and performance data they choose, and support each other's progress. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112176779/en/ WHOOP Launches WHOOP Humans, the Most Verifiably Human Social Network For more than a decade, WHOOP has helped members better understand their own health and performance. Now, WHOOP Humans extends that experience beyond the individual, making it easier to celebrate achievements, encourage progress, and look out for the people who matter most. "In a world that's becoming increasingly artificial, we're building something deeply human,” said Will Ahmed, Founder and CEO of WHOOP. “This is the most verifiably human network ever launched. Every account represents a real person with a verified heartbeat. They have real goals, challenges, and achievements. T
Integrated Hubs for Green Chemistry Research Aim to Transform How Chemicals and Materials Are Designed12.11.2026 18:00:00 EET | Press release
The Gordon and Betty Moore Foundation today announced four Integrated Research Hubs to explore new frontiers in chemical design, from materials that respond to their surroundings to molecules designed for safety from the start. Bringing together global researchers across institutions and disciplines, the hubs will investigate fundamental principles that could enable new capabilities in chemicals and materials while improving performance and protecting human health and the environment. The research priorities emerged through extensive engagement with the scientific community to identify the questions that could transform what chemistry can achieve. Each hub will connect researchers across institutions around one of four green chemistry focus areas: Safer molecular design: Led by The George Washington University, this hub will combine artificial intelligence and quantum chemistry to embed safety into chemical design from the outset. Adaptive catalytic systems: Led by the Max Planck Insti
Roquette Highlights Scalable Excipient and Capsule Solutions for Regional and Global Pharmaceutical Markets at CPHI India 202612.11.2026 17:00:00 EET | Press release
Roquette, a global leader in plant-based ingredients and a leading provider of pharmaceutical excipients, will showcase its comprehensive portfolio of excipient and capsule solutions at CPHI India 2026, Hall 1, Booth 1I12 from November 23 to 25, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112803410/en/ Meet Roquette at CPHI India 2026, Hall 1, Booth 1I12 At the event, Roquette will demonstrate how it helps pharmaceutical manufacturers accelerate the journey from formulation to market with confidence. By combining technical expertise, trusted quality, meaningful innovation and close collaboration, Roquette helps customers address formulation, scale-up and manufacturing challenges across a broad range of pharmaceutical applications. As India continues to play a critical role in supplying medicines to patients around the world, pharmaceutical manufacturers face increasing demands for quality, regulatory compliance,
Tigo Energy and Google Cloud Pair AI-Powered Tools for Solar Installers and Utilities12.11.2026 16:00:00 EET | Press release
Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced a collaboration with Google Cloud to develop AI-enabled operational workflows for solar installers and distributed energy portfolios. By making core Tigo data and software products available through Google Cloud, Tigo aims to deliver faster deployment, simplified data integration, and additional insights with Gemini. The resulting workflows will help installers, asset managers, and energy operators more easily identify issues, prioritize actions, and automate routine operational tasks across growing fleets of distributed energy systems. As solar and storage portfolios expand, energy businesses are increasingly responsible for managing more sites, more system data, and more customer interactions without a proportional increase in operational resources. Through collaboration with Google Cloud, Tigo is developing AI-assisted workflows to help opera
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