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
MarkLines Gen-AI Beta Version Released for Automotive Industry13.1.2026 01:00:00 CET | Press release
MarkLines Co., Ltd. (Headquarters: Minato-ku, Tokyo; President & CEO: Makoto Sakai; TYO:3901) announced its launch of the "MarkLines Gen-AI Beta Version," the new feature for B2B users in the automotive industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112383839/en/ "MarkLines Gen-AI Beta Version" can take questions in natural language and instantly give highly reliable, relevant data drawn from MarkLines’ extensive automotive database (Image: MarkLines Co., Ltd.) This AI-powered feature enables users to ask questions in natural language and instantly receive highly reliable, relevant data drawn from MarkLines’ extensive automotive database. Moreover, the system analyzes this information by leveraging the rich content across its platform and delivers clear, concise, text-based insights. By combining trusted data with advanced analytical capabilities through generative AI, this service represents a first-of-its-kind
Australian Defence Force Secures Satellite Communications on SES IS-2212.1.2026 22:30:00 CET | Press release
New agreement for uninterrupted UHF connectivity for Australian Defence Force through 2033, With Options Extending to 2041 Satellite communications solutions provider SES will provide secure uninterrupted satellite communications to the Australian Defence Force (ADF) for a minimum of 16 years thanks to a new extended agreement. The service will be provided via the SES Intelsat 22 satellite and an ultra-high frequency (UHF) military communications payload. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112137182/en/ Assistant Secretary Space Systems Branch, Michael Hunt, formalizes contract negotiations for the through-life support of the IS-22 satellite with Rory Welch, senior vice-president of service delivery at SES Space and Defense. Photos: Corporal Annika Smit Under the renewed arrangement, SES will reposition the IS-22 satellite to a new orbital slot specified by the ADF, continuing a mission that has been the corne
NetApp Appoints Paul Fipps to the Board of Directors12.1.2026 22:05:00 CET | Press release
NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced that Paul Fipps, President of Global Customer Operations at ServiceNow, has joined its Board of Directors. The board now has ten directors, nine of whom are independent, and 50% of whom have been appointed within the last five years. Fipps brings more than 20 years of experience driving technology-enabled growth and customer transformation. At ServiceNow, he currently leads global sales, customer success, partner ecosystems, and field operations. He previously served as EVP of Worldwide Sales at ServiceNow and as President of Under Armour Connected Fitness and Chief Experience Officer at Under Armour, overseeing global direct-to-consumer, connected fitness, and digital experiences. He also previously served on the advisory board of Quantum Metric. Fipps holds a B.S. in Information Systems, an MBA from the University of Baltimore, and is a graduate of The Wharton School’s Advanced Management Program. “P
FDA Accepts New Drug Application for Pimicotinib for the Treatment of Tenosynovial Giant Cell Tumor12.1.2026 20:00:00 CET | Press release
Not intended for Canada-, UK- or US-based media Merck, a leading science and technology company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) for pimicotinib as a systemic treatment for patients with tenosynovial giant cell tumor (TGCT). The application is based on the primary results and longer-term follow-up of the global Phase 3 MANEUVER study, which demonstrated deep and durable tumor responses and meaningful improvements in clinical outcomes with pimicotinib. “With pimicotinib, we have an opportunity to significantly advance care for people living with TGCT, a painful and debilitating disease that has few effective and well-tolerated treatment options beyond surgery,” said David Weinreich, Global Head of R&D and Chief Medical Officer for the Healthcare business of Merck. “Based on clinical trial results showing not only a reduction in tumor burden, but also the ability to help alleviate symptoms like pain an
Fabentech receives Marketing Authorization for Ricimed®, an antidote against ricin poisoning12.1.2026 19:32:00 CET | Press release
First Marketing Authorization granted in France for the treatment of ricin poisoning, one of the most toxic natural substances in the world and a recognized priority biological threat. Ricimed® addresses a previously unmet medical need in the management of severe and potentially fatal ricin intoxications.Supported by the French Ministry of the Armed Forces and Veterans Affairs (the Directorate General of Armaments and the French Military Health Service), the development of Ricimed® illustrates Fabentech’s transition to a new scale and, with recent support from the European HERA Invest program, reinforces its positioning as a reference player in medical countermeasures against biological threats, serving both civilian and military markets. Fabentech, a French biopharmaceutical company specializing in medical countermeasures against biological threats, today announces that it has been granted Marketing Authorization for Ricimed®, a treatment for ricin poisoning. This press release featur
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