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
Bureau Veritas to Acquire a Leading Sustainability Specialist for Consumer Products in Italy23.1.2026 18:13:00 CET | Press release
Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), announces the acquisition of SPIN360, a leading Italian consulting firm specialized in sustainable innovation and development across primary premium fashion and luxury brands. This acquisition aligns with Bureau Veritas’ LEAP | 28 strategy to create new strongholds in the Consumer Product Services (CPS) industry, and to accelerate its growth in key markets such as Italy. The transaction will deliver on value creation opportunities, by combining SPIN360's proprietary Life Cycle Assessment (LCA) tools and data-driven advisory services with Bureau Veritas' certification and supply chain auditing expertise. It will also help position Bureau Veritas as a global center of excellence for premium fashion and luxury. Created in 2009 and based in Milan, SPIN360 provides technical advisory services covering LCA, life cycle costing, environmental product declarations, carbon footprint, supply chain engagement
HCLTech to Acquire Singapore-based Finergic to Boost Digital Transformation Offerings for Wealth Management Industry23.1.2026 17:55:00 CET | Press release
HCLTech, a leading global technology company, today announced that it has signed a definitive agreement to acquire Finergic Solutions Pte Ltd, a boutique wealth consulting firm headquartered in Singapore. The transaction is expected to close by April 30, 2026. Founded in 2019, Finergic focuses on core banking and wealth management transformation and has a strong, well-established global presence. The addition of Finergic’s niche capabilities, combined with the scale of HCLTech, is expected to unlock stronger synergies and enhance service delivery across the financial services and wealth management industry. HCLTech brings 25+ years of global experience in serving leading financial institutions. By integrating Finergic’s specialized transformation strategy, consulting and wealth-architecture capabilities, HCLTech will accelerate the delivery of next-generation, platform-enabled wealth management solutions anchored by advanced AI-native workflows. These capabilities will complement HCLTe
Saudi Arabia to Host World Economic Forum Global Collaboration and Growth Meeting: Building Common Ground and Reviving Growth on 22-23 April 202623.1.2026 16:29:00 CET | Press release
Saudi Arabia will host the World Economic Forum (WEF) Global Collaboration and Growth Meeting: Building Common Ground and Reviving Growth in Jeddah on 22-23 April 2026, it was announced on the closing day of the 56th Annual Meeting of the Forum in Davos, Switzerland. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260123725881/en/ HE Faisal F. Alibrahim, Saudi Arabia’s Minister of Economy and Planning, announces that the Kingdom will host the World Economic Forum Global Collaboration and Growth Meeting in Jeddah in April 2026 (Photo: AETOSWire) His Excellency Faisal F. Alibrahim, Saudi Arabia’s Minister of Economy and Planning today confirmed the details for the regular high-level WEF meeting, which was announced at the 2025 WEF Annual Meeting. Calling for pragmatism and collaboration against a backdrop of geopolitical fragmentation, HE Alibrahim said “stability can’t be quickly built, and it can’t be bought”. “Stability need
Philip Morris International Urges FDA Advisory Committee to Recommend Authorizing ZYN as a Modified Risk Tobacco Product23.1.2026 15:15:00 CET | Press release
In January 2025, ZYN became the first nicotine pouch product authorized for marketing by the FDA Experts from Philip Morris International (PMI) (NYSE: PM) yesterday presented scientific evidence to the U.S. Food and Drug Administration’s (FDA) Tobacco Products Scientific Advisory Committee (TPSAC) as part of the FDA’s process for a Modified Risk Tobacco Product (MRTP) designation for their ZYN nicotine pouch products. This designation would allow PMI’s U.S. family of businesses to communicate to U.S. legal-aged, 21+ adult cigarette smokers that switching completely to ZYN reduces their risk of many smoking-related diseases and we look forward to a decision by FDA. "The FDA’s Center for Tobacco Product’s (CTP) mission is to make smoking-related disease and death a part of America’s past,” said Keagan Lenihan, Chief External Affairs Officer for PMI U.S. “Smoke-free products, like ZYN, play a critical role in helping CTP achieve this mission and provide adults who smoke with important inf
Business4Land Champions’ Council Launched at Davos to Spur Private Sector Action on Land and Drought23.1.2026 14:58:00 CET | Press release
The UNCCD COP16 Presidency, led by Saudi Arabia, and the United Nations Convention to Combat Desertification (UNCCD) Secretariat launched the Business4Land (B4L) Champions’ Council at the World Economic Forum in Davos to mobilize global CEOs and industry leaders in support of large-scale land restoration. The B4L Champions Council members include ten companies: Nexira, Suzano, Gut & Bösel, Patagonia Provisions/ B.Cameron Consulting, Olam Group, Reservas Votorantim, Genesis Soil Health, EY, Envision Energy, and LVMH The move marks the beginning of a more structured and strategic engagement with the private sector ahead of COP17. TheUnited Nations Convention to Combat Desertification(UNCCD) Secretariat and the UNCCD COP16 Presidency, led by the Kingdom of Saudi Arabia, today announced the official launch of the Business4Land (B4L) Champions’ Council at a high-level event hosted at InTent during the World Economic Forum (WEF) Annual Meeting in Davos. This press release features multimedia
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