DE-INCYTE
21.8.2024 17:41:34 CEST | 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.
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
Kubota Vision Inc. Signs Supply and Licensing Agreement with Laboratoires KÔL for Stargardt Disease Treatment Candidate Under Compassionate Use4.5.2026 17:16:00 CEST | Press release
Kubota Vision Inc. (“Kubota Vision”), a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Minato-ku, Tokyo, Japan) announced signing of a Supply and Licensing Agreement with Laboratoires KÔL (Clermont-Ferrand, France) for the provision of a Stargardt disease (STGD1) treatment candidate under compassionate use authorization. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260414590785/en/ The purpose of this Agreement is for Kubota Vision and KÔL to collaborate on providing “Emixustat” for treatment of Stargardt Disease (STGD1) through compassionate use authorization in France. Kubota Vision will exclusively manufacture and supply Emixustat final products to KÔL and KÔL will have exclusive rights to distribute Emixustat in France under compassionate use access. Ryo Kubota, Chairman, President, and CEO of Kubota Pharmaceutical Holdings, stated, “We are extremely pleased to enter into this Agreement with Labor
Incentive Market Set to Surpass $80B by 2030s — IMA Launches Tools to Help the Industry Keep Pace4.5.2026 16:28:00 CEST | Press release
With combined business spend on loyalty, employee recognition, and channel incentives projected to exceed $80 billion by the 2030s, the incentive industry is entering a period of rapid scale and strategic pressure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260422729016/en/ In response, the Incentive Marketing Association (IMA) launched a new suite of resources designed to help incentive professionals navigate an environment that’s becoming more specialized, fragmented, and central to business performance. “It’s not just more money coming in—it’s more complexity,” said Vince Chiofolo, President of the Incentive & Engagement Solution Providers (IESP). “Buyers are demanding programs that evolve fast, integrate deeply, and feel personal at scale. These new tools were built for that.” IMA’s Suite of Tools Includes: New Industry Report — Inside the Incentive Buyer’s Mind Drawn from insights of 50+ program owners, the report f
Tigo Energy Breaks Global Growth Benchmark; Boosts U.S. Energy Feature in Predict+4.5.2026 15:00:00 CEST | Press release
Advanced energy prediction platform adds real-time energy pricing for North American Independent System Operator (ISO) customers, accelerates meters-connected growth. Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy solutions, today announced that the Predict+ platform now offers integrated real-time spot market pricing for ISO customers in the United States. Predict+ provides utilities with deep insights into grid demand, renewable generation, and energy market dynamics, enhancing the precision, scalability, and robustness of energy forecasting to up to 97.5% accuracy through machine learning and artificial intelligence. For energy providers, Predict+ helps streamline operations, reduce volatility, and maximize performance. Predict+ empowers utility operators to adapt to real-world demand challenges when balancing renewable and baseload generation sources, particularly during extreme weather events and market disruptions. On th
Airship Announces 2026 Elevate Customer Experience Award Winners4.5.2026 15:00:00 CEST | Press release
Southwest Airlines, The Economist, and OneFootball among brands recognized at Elevate’26 Customer Experience Summit for setting the standard in mobile-first and AI-centered customer experiences Airship, the mobile-first customer experience company, today announced the winners of the 2026 Elevate Customer Experience Awards. Global brand leaders from The Economist, Southwest Airlines, and OneFootball were among those honored at the Elevate’26 Customer Experience Summit. The Elevate Awards spotlight global companies that have developed exceptional mobile-first customer experiences for their customers, created innovative campaigns, leveraged AI agents to reach new levels of productivity, and achieved real business results. "Evolving mobile-first consumer behaviors and unprecedented advancements in AI are driving a seismic shift that is reshaping how brands interact with their customers," said Brett Caine, CEO, Airship. "The 2026 Elevate Award winners aren’t just adapting, they’re leading t
Alnylam to Present New Analyses at Heart Failure 2026 Underscoring Consistent Clinical Profile of Vutrisiran in ATTR-CM4.5.2026 14:30:00 CEST | Press release
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced it will present new data analyses for vutrisiran in patients with the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) at Heart Failure 2026, a scientific congress of the European Society of Cardiology, taking place May 9-12, 2026, in Barcelona, Spain. ATTR-CM is a heterogeneous and rapidly progressive disease, and patients often present with complex clinical profiles. At Heart Failure 2026, Alnylam will present multiple new analyses from the Phase 3 HELIOS-B study of vutrisiran, which continue to support its use as a first-line treatment for patients with ATTR-CM, and further characterize its clinical profile across patients with a high disease burden, and in the context of concomitant therapies. Vutrisiran is the first and only transthyretin (TTR) silencer for ATTR-CM that delivers rapid knockdown of TTR at the source. Additional analyses being pr
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