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
Transition Industries Signs Strategic Agreements for the Pacifico Mexinol Project, the Largest Standalone Ultra-Low Carbon Chemical Production Facility in the World30.6.2025 20:30:00 CEST | Press release
Pacifico Mexinol project, a 6,130 MT per day ultra-low carbon methanol production facility worth more than US$3.3b will be located near Topolobampo, Ahome, Sinaloa. Once operational in 2029, Pacifico Mexinol is poised to be the largest standalone ultra-low carbon chemical production facility in the world. Transition Industries LLC, a developer of world-scale, net-zero carbon emissions methanol and green hydrogen projects in North America, held a signing event for an Engineering, Procurement, and Construction (EPC) contract with the consortium of Samsung E&A Co., Ltd. (Samsung E&A), Grupo Samsung E&A Mexico, S.A. de C.V., and Techint Engineering and Construction for the Pacifico Mexinol project located in Ahome, Sinaloa, Mexico, which is contingent upon the fulfillment of customary conditions precedent and obtainment of all required approvals. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630940954/en/ MAIRE group’s techn
Westinghouse and ITER Sign a $180M Contract to Advance Nuclear Fusion30.6.2025 15:45:00 CEST | Press release
The contract includes the assembly of the fusion reactor’s vacuum vessel, a key milestone which gets the project closer to replicating fusion energy on Earth Westinghouse Electric Company and ITER signed a contract for $180 million for the assembly of the vacuum vessel for the fusion reactor. This is a key milestone in the construction of the ITER reactor, leading the way toward the use of fusion as a practical future source of reliable carbon-free energy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630497810/en/ The ITER Tokamak pit with the two vacuum vessel sector modules installed. Westinghouse has participated in the fabrication of the sectors of the vacuum vessel, as part of the Fusion for Energy (F4E) Consortium with its partners Ansaldo Nucleare and Walter Tosto. Westinghouse will be responsible for completing the vacuum vessel which is ITER’s most critical component: a hermetically sealed, double-walled steel
Monetate Acquires SiteSpect to Deliver AI-Native Personalization and Testing at Enterprise Scale30.6.2025 15:00:00 CEST | Press release
Monetate’s Real-Time Personalization Unites with SiteSpect’s Zero-Flicker Testing to Optimize Digital Experiences with Unmatched Speed, Precision, and SecurityNow Global Ecommerce and Digital Experience Leaders Can Access a Best-in-Class, Enterprise-Grade Personalization, Testing, and Optimization Platform Monetate, the leading AI-driven personalization platform, today announced it has acquired SiteSpect, a leader in A/B testing, to drive next-generation digital experience optimization. This acquisition accelerates Monetate’s vision to deliver intelligent, intentional, and individualized experiences at scale, powered by agentic AI and backed by the industry’s most advanced, enterprise-grade infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630514541/en/ The combination of Monetate’s real-time personalization and SiteSpect’s zero-flicker testing will yield an industry-first solution for enterprise-grade person
SS&C Blue Prism Recognized as a Gartner® Magic Quadrant™ RPA Leader for the Seventh Consecutive Year30.6.2025 15:00:00 CEST | Press release
SS&C Technologies Holdings, Inc. (Nasdaq: SSNC) today announced that SS&C Blue Prism has been recognized as a Leader in the 2025 Gartner Magic Quadrant for Robotic Process Automation (RPA). “We’re delighted SS&C Blue Prism has been named a Leader in the Gartner Magic Quadrant for Robotic Process Automation for the seventh year running,” said Bill Stone, CEO and Chairman of SS&C Technologies. “SS&C Blue Prism combines market-leading RPA and orchestration technologies with the latest artificial intelligence so organizations can tackle more complex tasks and dynamic business processes. We’ve scaled to more than 2,700 digital workers and AI agents across our own operations, resulting in over $200 million in annual savings. With SS&C leading the charge on deployment, customers can be confident in rolling out SS&C’s automation solutions securely, effectively, and responsibly.” More than 2,800 companies worldwide leverage SS&C Blue Prism for AI-powered automation, helping organizations delive
Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content130.6.2025 14:00:00 CEST | Press release
GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with Less Than or Equal to 2 µg/mL IgA in a 10% Solution is Approved for Intravenous or Subcutaneous Use in People Aged Two and Older with Primary Immunodeficiency1U.S. Commercialization of GAMMAGARD LIQUID ERC Projected to Begin in 2026Company Announces Future Manufacturing Discontinuation End Date for Takeda's First-Generation Low-IgA Product, A Freeze-Dried Formulation in Company’s Differentiated Immunoglobulin Portfolio of Ready-to-Use Liquids2 Takeda(TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with less than or equal to 2 µg/mL IgA in a 10% solution, the only ready-to-use liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content, as replacement therapy for people two years of age and older with primary immunodeficiency (PI). As a ready-to-use liquid, GAMMAGARD LIQUID ERC may help ease the administratio
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