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
Samsung Epis Holdings Delivers Business Updates at the 44th J.P. Morgan Healthcare Conference15.1.2026 01:40:00 CET | Press release
Samsung Bioepis plans to secure 20 biosimilars in its products and pipeline by 2030The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab, in addition to pembrolizumab currently in Phase 1 and 3 clinical studiesHaving secured investigational new drug application (IND) clearance from the U.S. Food and Drug Administration (FDA), SBE303, Samsung Bioepis’ novel antibody-drug conjugate (ADC) engineered to target Nectin-4, will enter into the Phase 1 first-in-human clinical trial this yearSamsung Bioepis plans to add one novel therapeutic candidate in clinical study every year Samsung Epis Holdings (KRX: 0126Z0) today shared corporate progress and updates at the 44th J.P. Morgan Healthcare Conference. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114206458/en/ Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings "2026 is a mon
Most Delivered Light-Entry Jet Cessna Citation M2 Gen2 With Garmin Autothrottles Enters Into Service, Bringing Greater Control and Precision to Pilots14.1.2026 20:30:00 CET | Press release
The Cessna Citation M2 Gen2 with Garmin Autothrottles recently entered into service. Certified by the Federal Aviation Administration in October 2025, the integration of Garmin’s Autothrottle system in the Citation M2 Gen2 further supports the most delivered light-entry jet’s capabilities by bringing greater control and precision to pilots. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114646844/en/ Most delivered light-entry jet Cessna Citation M2 Gen2 with Garmin Autothrottles enters into service, bringing greater control and precision to pilots (Photo Credit: Textron Aviation). The Cessna Citation M2 Gen2 is designed and manufactured by Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company. “We continue to invest in our products to provide customers with the best aviation experience in the world," said Lannie O’Bannion, senior vice president, Sales & Marketing. “The M2 Gen2 leads its segment as the most delivered
TwentyTwo Real Estate and Farallon Capital Complete €761 Million Investment in Isemia, a €1.2bn Healthcare Real Estate Company Created With emeis14.1.2026 18:30:00 CET | Press release
TwentyTwo Real Estate, an independent European real estate investment and management firm, announces the completion, alongside Farallon Capital, of a €761 million investment that led to the creation of Isemia (www.isemiabyemeis.com), a leading healthcare real estate company holding a €1.2 billion portfolio of assets operated by emeis. The transaction represents a significant milestone in TwentyTwo Real Estate’s long-term investment strategy focused on healthcare and operational living real estate. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114262830/en/ Fachklinik Schömberg Isemia comprises 68 high-quality assets across France, Germany and Spain, with a balanced mix of nursing homes (48%) and clinics (52%). The portfolio benefits from strong fundamentals and resilient operating performance. All properties will continue to be operated by emeis under long-term lease agreements, ensuring continuity of care for residents
AI’s Water Demand to Surge Nearly 130% by 2050 – New Research Shows How to Build a Water-Secure AI Economy14.1.2026 16:00:00 CET | Press release
Analysis finds AI could add 30 trillion liters of annual water demand, but targeted reuse and digital infrastructure investments can substantially offset demand and protect communities The rapid global expansion of artificial intelligence is set to drive a 129% increase in water demand across the AI value chain by 2050, according to new research by Xylem (NYSE: XYL) and Global Water Intelligence (GWI). Watering the New Economy: Managing the Impacts of the AI Revolution provides the most comprehensive assessment to date of how AI is reshaping global water use. It also highlights practical ways to meet that demand while strengthening water security for communities. Spending on AI is forecast to approach $2 trillion in 2026,1 accelerating infrastructure build-out worldwide. By the middle of the century, this expansion is projected to add 30 trillion liters of water demand, annually, fueled by a surge in power generation (~54% of the increase), semiconductor fabrication (~42%), and data ce
ACCELQ Crowned Leader and Customer Favorite in The Forrester Wave™ for Autonomous Testing Platforms14.1.2026 16:00:00 CET | Press release
Agentic Test Automation Pioneer Caps Record-Breaking Year of Growth and "AI-Based Engineering Solution of the Year" Honors Forrester has named ACCELQ a Leader in The Forrester Wave™: Autonomous Testing Platforms, Q4 2025. This marks the third consecutive Wave in which ACCELQ has been recognized as a Leader. Notably, this evaluation placed strong emphasis on generative AI innovation and real-world customer adoption. ACCELQ received the highest scores for both capabilities and vision and was the only platform to be recognized as a Customer Favorite, earning a "double halo" for exceptional customer endorsement. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260113112861/en/ ACCELQ recognized as a Leader and Customer Favorite in The Forrester Wave™️: Autonomous Testing Platforms, Q4 2025, validating its agentic, GenAI-embedded testing vision. According to the Forrester report, ACCELQ received the highest score among all evaluate
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