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
YES Announces Leadership Transition as Rezwan Lateef Appointed Chief Executive Officer3.12.2025 20:24:00 CET | Press release
YES (Yield Engineering Systems), a leading provider of high-performance process solutions for the semiconductor Advanced Packaging market, today announced that Rezwan Lateef has been appointed Chief Executive Officer. Mr. Lateef previously served as President of YES and has been a key driver of the company’s significant growth, global expansion, and product innovation over the past several years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251202200541/en/ Rezwan Lateef, CEO of YES. The transition marks a natural progression for the company as it surpasses a key revenue milestone and enters its next phase of scaling with top tier semiconductor and AI computing customers. Rama Alapati, who has served as CEO since 2021, will step into a consulting role to support Mr. Lateef during the transition period and ensure strong organizational continuity. “Rama has played an instrumental role in elevating YES from a promising techno
Doha Debates Examines How Entertainment Shapes Us Today3.12.2025 18:13:00 CET | Press release
In a new episode, leading thinkers and students debate whether today’s entertainment elevates us or pulls us into distraction. Qatar Foundation’s Doha Debates continues its flagship debate series with a new episode that examines how modern entertainment shapes our attention, creativity, and everyday well-being. Moderated by Dareen Abughaida, the debate brings together three influential thinkers to ask whether today’s entertainment landscape is enriching us—or overwhelming us. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251203737439/en/ Doha Debates examines how entertainment shapes us today in a new episode, leading thinkers and students debate whether today’s entertainment elevates us or pulls us into distraction. (Photo: AETOSWire) This week’s debate features Marya Bangee, Senior Advisor at the Pop Culture Collaborative; Dr. Anna Lembke, Professor of Psychiatry at Stanford University and author of Dopamine Nation; and N
Vycellix Prepares for First-in-Human Study of Novel Allogeneic Cell Therapy Powered by Its Universal Cell Engineering Platform3.12.2025 18:00:00 CET | Press release
- Single-step CD45-engager technology shows robust immune evasion with functional persistence in pre-clinical models - Phase 1 study to evaluate ‘off-the-shelf’ natural killer cell cancer immunotherapy in the treatment of multiple myeloma Vycellix, Inc., a biotechnology company developing next-generation allogeneic cell therapies designed to overcome the risk of immune rejection, today announced the successful completion of pre-clinical development for its universal cell engineering platform (VY-UC) with rigorous studies across many donor cell types proving robust immune evasion with functional persistence. The Company is now preparing for first-in-human clinical validation by seeking regulatory approval in Sweden to initiate a Phase 1 study for its lead VY-UC product candidate, a novel, off-the-shelf natural killer (NK) cell therapy (VNK-101) for patients with relapsed or refractory multiple myeloma. VY-UC is a single-step CD45 engager strategy intended to address a central barrier to
Andersen Consulting forstærker platformen med Peers Technology + Consulting3.12.2025 17:45:00 CET | Pressemeddelelse
Andersen Consulting tilføjer samarbejdspartneren Peers Consulting + Technology, et brasiliansk firma kendt for at fremme strategiske forandringer gennem digital innovation og avanceret analyse. Peers blev stiftet i 2012 og leverer helhedsorienterede løsninger, der kombinerer strategisk indsigt med digital eksekvering. Deres ydelser spænder over avanceret analyse og generativ ai, it-strategi, kundeoplevelse, finans, cybersikkerhed, bæredygtighed, forsyningskæde, M&A og organisatorisk transformation. Peers er anerkendt for sin indflydelse i hele Latinamerika og ruster kunder til at modernisere driften, forbedre beslutningstagningen og skabe bæredygtige resultater. “Vi tror på, at meningsfuld transformation sker i krydsfeltet mellem data, teknologi og menneskelig indsigt,” udtaler administrerende partner Pedro Ribeiro. “Vi arbejder side om side med vores kunder for at omdanne udfordringer til vækst. Samarbejdet med Andersen Consulting giver os mulighed for at udbrede denne tilgang globalt
DevvStream and Southern Energy Renewables Announce Business Combination Targeting Low-Cost Production of Carbon-Negative SAF and Green Methanol3.12.2025 15:40:00 CET | Press release
Combination integrates carbon-credit origination expertise with U.S.-produced, lower-cost carbon-negative fuels to meet growing global demandSouthern secures a $402 million bond allocation from the Louisiana Community Development Authority in support of its flagship biomass-to-fuel facilitySouthern makes initial PIPE Investment in DevvStream of approximately $2.0 million at $15.58 per share DevvStream Corp. (Nasdaq: DEVS) (“DevvStream”), a leading carbon management and environmental-asset monetization firm, and Southern Energy Renewables Inc. (“Southern”), a U.S.-based producer of low-cost fuels made from biomass, with a flagship Louisiana project that plans to utilize regional wood-waste biomass to deliver green methanol and carbon-negative sustainable aviation fuel (“SAF”) at scale, today announced that they have entered into a definitive agreement to combine under a new U.S.-domiciled, Nasdaq-listed company, following customary closing conditions. The new company plans to help aviat
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