DE-INCYTE
21.8.2024 17:41:34 CEST | 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.
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
Align Partners Issues Formal Shareholder Proposals to Gabia13.2.2026 01:37:00 CET | Press release
Align Partners Capital Management Inc. (“Align Partners”), a shareholder of Gabia, Inc. (“Gabia” or the “Company”), has submitted formal shareholder proposals for inclusion in the agenda of Gabia’s upcoming 27th Annual General Meeting (“AGM”) and issued a call for strengthened governance practices to address the Company’s persistent undervaluation. Align Partners noted that, as shareholder proposals will be presented at this year’s AGM, Gabia should follow the Korea Exchange (KRX) Corporate Governance Key Indicators by publishing the AGM convocation notice at least four weeks prior to the meeting date. Align Partners emphasized that last year’s AGM notice was issued only 16 days before the meeting, limiting shareholders’ ability to adequately review the agenda and exercise informed voting rights. Gabia is widely recognized as a leading Korean IT services and cloud infrastructure company with solid operating performance. Despite these strengths, Align Partners believes the Company conti
Andersen Consulting udvider sin platform i Nordamerika med tilføjelsen af Kezber12.2.2026 22:50:00 CET | Pressemeddelelse
Andersen Consulting styrker sine ydelser inden for forretningstransformation og cybersikkerhed med tilføjelsen af den canadisk-baserede samarbejdsvirksomhed Kezber. Kezber blev stiftet i 1996 og specialiserer sig i at levere en komplet pakke af it-løsninger, herunder managed it-services, infrastruktursupport, cybersikkerhed, cloudtjenester, specialudviklet software, business intelligence og ai-tjenester samt automatisering af forretningsprocesser. Firmaet samarbejder med organisationer med henblij på at øge produktiviteten, modernisere deres teknologiske miljøer og udnytte datadrevne løsninger til at nå strategiske mål. "Vores samarbejde med Andersen Consulting giver os mulighed for at inddrage hele vores pakke af software og it-tjenester i en bredere konsulentramme," udtaler Alan Kezber, administrerende direktør for Kezber. "Ved at integrere vores tekniske ekspertise med Andersen Consultings omfattende konsulentkompetencer kan vi tilbyde kunderne løsninger, der skaber driftsforbedring
Europe Launches Euro-Q-Exa Quantum Computer in Germany, Strengthening Sovereign Digital Infrastructure12.2.2026 21:15:00 CET | Press release
Euro-Q-Exa will serve the scientific community and industry across Germany and Europe, enabling hands-on quantum research and application development within Europe’s HPC ecosystem. Installed, hosted, and operated at Leibniz Supercomputing Centre (LRZ), ensuring local control, operational expertise, and long-term capability building. Developed by IQM Quantum Computers using its Radiance platform, designed to enable institutions to build, operate, and evolve their own quantum capability. Engineered for deep integration with high-performance computing, supporting scalable hybrid quantum–HPC workflows. Co-funded by the EuroHPC Joint Undertaking, the German Federal Ministry of Research, Technology and Space (BMFTR), and the Bavarian State Ministry of Science and the Arts (StWK). Euro-Q-Exa, the first EuroHPC Joint Undertaking quantum computer deployed in Germany, has been unveiled at the Leibniz Supercomputing Centre (LRZ) in Garching, Munich. This press release features multimedia. View th
Sindre Zeiner-Gundersen Joins Joi Scientific12.2.2026 20:00:00 CET | Press release
Joi Scientific is pleased to welcome Sindre Zeiner-Gundersen as the company’s Advanced Plasma & Resonant Energy Physicist. Sindre will lead Joi’s scientific activities including all aspects of Joi’s science program. Sindre is a quantum physics expert who previously served as CEO/President of Nornec AS, a Norwegian consulting and engineering services company. Nornec has been a consultant to Joi since 2024. At Nornec, Sindre provided consulting and R&D services in the areas of advanced nuclear reactor simulations, process and plant optimization, carbon capture optimization, materials selection and radiation effects, custom reactor design, muon and neutron detector systems, muon and catalyzed fusion and Hydrogen Rydberg Matter research. An applied physicist with end‑to‑end expertise in energy‑carrier gases - ammonia, methanol, hydrogen - as well as a radiation instrumentation specialist with experience in process and equipment design across the ammonia/hydrogen value chain, Sindre has aut
Angelalign Technology Inc. (6699.HK) Says a Preliminary European Court Ruling on Certain Software Features Will Have Minimal Impact on Users12.2.2026 17:58:00 CET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel”) said a ruling by the Unified Patent Court of Düsseldorf, Germany that it preliminarily cease its use of certain software functions that automatically update treatment plans would have minimal impact on the orthodontists and patients who use its clear aligner products. The ruling applies to certain European countries and excludes Spain, Switzerland, United Kingdom and Ireland. Angel will launch iPlan for applicable European users, which is an upgrade feature that has the same reliability and more flexibility for users. Angel denies that the Live Now feature in its iOrtho treatment planning software infringes any valid patents of Align Technology Inc. (ALGN). Angel has already filed an opposition against the patent with the European Patent Office (EPO), arguing that the claimed invention is neither novel nor inventive over the prior art, and is seeking its permanent invalidation. Angel is confident it will overcome the first-instance, non-fi
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