Incyte to Present Late-Breaking Phase 3 Results for Retifanlimab (Zynyz ® ) and Initial Data from Phase 1 CDK2 Inhibitor Program at the European Society of Medical Oncology (ESMO) Congress 2024
21.8.2024 18:40:00 EEST | 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240821420609/en/
Contacts
Media
media@incyte.com
Investors
ir@incyte.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
www.businesswire.com
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
From Network Automation to Agentic NetOps: NetBrain Sets the Standard for Deploying AI in Network Operations29.5.2026 16:00:00 EEST | Press release
NetBrain Technologies, Inc. today announced major new platform features that advance Agentic NetOps from an emerging category to operational reality. NetBrain's clients are already deploying agents that are diagnosing and remediating issues across complex multi-vendor enterprise networks. These new features further extend the platform with new agent tooling, cross-domain context, and open interfaces for the broader agentic enterprise. Early customer outcomes show the magnitude of the shift: A leading health insurer used NetBrain's Deep Diagnosis agent to diagnose and resolve a weeks old VPN connectivity issue in under five minutes. A large manufacturer resolved a critical device issue with a single prompt, isolating the root cause across the network path in under 20 minutes, saving hundreds of hours of engineer time, shrinking MTTR by more than 95%. A global telecommunications firm found NetBrain's context-grounded agents outperformed a stand-alone frontier LLM on a persistent firewall
Adtran resolves long-running patent litigation, reinforcing commitment to defend innovation29.5.2026 15:00:00 EEST | Press release
Adtran today announced it has resolved a patent litigation matter, resulting in a full settlement and dismissal of all claims with prejudice. The case, initiated in 2020 by a non-practicing entity asserting five patents, was transferred to the US District Court for the Northern District of Alabama in 2021 following a successful motion by Adtran. Adtran subsequently filed counterclaims, including bad-faith patent assertion under Alabama statutory law. The settlement includes payment to Adtran to resolve its counterclaims. Terms of the agreement remain confidential. “This outcome reflects a disciplined and consistent approach to protecting our innovation and our customers,” said Justin Ferguson, SVP and general counsel at Adtran. “We take all claims seriously, but we will not hesitate to defend ourselves when assertions lack merit. Situations like this place unnecessary strain on technology providers and divert resources from advancing networks and services. By advancing our counterclaim
Meiji Seika Pharma Invests in GHIC’s Global Health Security Fund29.5.2026 14:00:00 EEST | Press release
Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan; President and Representative Director: Toshiaki Nagasato) today announced that it has committed to invest in the Global Health Security Fund (GHSF), which is sponsored by Global Health Investment Corporation (GHIC), a New York-based nonprofit organization. Through this investment, Meiji Seika Pharma will support the acceleration of innovations addressing critical global health challenges, including pandemic preparedness and antimicrobial resistance (AMR). GHIC is a mission‑driven nonprofit organization that deploys private investment strategies to generate both global health impact and financial returns. GHIC recently closed its second fund in GHSF. With more than a decade of experience investing in the field of infectious disease, GHIC has contributed to addressing major global health challenges. Its portfolio companies have successfully commercialized more than a dozen products, collectively reaching over 600 million people wo
IFF Enters Into Agreement to Sell Its Food Ingredients Business to CVC29.5.2026 13:50:00 EEST | Press release
IFF (NYSE: IFF), a global leader in flavors, fragrances, food ingredients, and health and biosciences, today announced that it has entered into an agreement to sell its Food Ingredients business to funds advised by CVC Capital Partners, a leading global private markets manager, in a transaction that values the business at approximately $4.3 billion, representing an enterprise value-to-EBITDA multiple of approximately 10x. As part of the transaction, IFF has chosen to retain an approximately 10% minority equity interest in the business, or approximately $200 million, permitting continued collaboration and cooperation between IFF and Food Ingredients and allowing IFF and its shareholders to participate in future value creation under its new ownership. The transaction marks a significant step in IFF’s portfolio transformation and is expected to strengthen the company’s focus on its innovation-driven businesses: Taste, Scent, and Health & Biosciences. Following the transaction, IFF will be
BeOne Medicines Establishes Standard for Long-Term Disease Control in CLL with BRUKINSA 78-Month Data at ASCO 202629.5.2026 13:00:00 EEST | Press release
BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, is advancing the treatment paradigm in chronic lymphocytic leukemia (CLL) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. With extensive long-term follow-up, the SEQUOIA study of BRUKINSA® (zanubrutinib) reinforces its role as the foundational BTK inhibitor, showing sustained disease control over years of therapy. These findings are further supported by real-world evidence across three large analyses encompassing more than 250,000 patients, underscoring consistent effectiveness and safety in clinical practice. Additionally, BEQALZI™ (sonrotoclax), which was recently approved by the U.S. Food and Drug Administration, and its development in combination with BRUKINSA (ZS) highlight the potential for next-generation, time-limited treatment approaches in CLL. Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said: “CLL is a disease patients live with
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