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
TestMu AI Introduces the Source-to-Verdict Loop in Kane CLI, Carrying Every Requirement to a Ship Decision With Portable Proof23.7.2026 15:45:00 CEST | Press release
Kane CLI now takes a requirement all the way to a ship-or-hold verdict, designing the tests, running them in a real browser, and emitting an open .evidence proof pack that teammates, AI agents, and auditors can all verify, with no server or dashboard required TestMu AI (formerly LambdaTest), the world's first Agentic AI-powered Quality Engineering platform, introduced a source-to-verdict loop in Kane CLI, its natural-language testing tool. Building on Kane CLI's evolution from a browser automation tool, the loop carries a product requirement to a ship decision, writing the tests, running them in the local browser, collecting the proof, measuring coverage from what actually happened, and returning a verdict. As AI agents write, run, and fix tests, a green checkmark is no longer enough: a step that checks nothing passes, a test written against a spec that changed weeks ago passes, and an agent that says “done” without the click ever landing passes. Empty green and earned green are the sa
Norway’s health system adopts Wolters Kluwer UpToDate Enterprise Edition23.7.2026 15:30:00 CEST | Press release
Enterprise Clinical Decision Support solution available to 30,000 clinicians in more than 50 Norwegian hospitals Wolters Kluwer Health announced that Norway’s health system has renewed its adoption of UpToDate Enterprise Edition, a market-leading Clinical Decision Support (CDS) solution, for its nationwide health system which includes over 50 public hospitals and 11,000 beds in over 20 trusts. This extends a 15 year partnership with Helsebiblioteket, now part of the Norwegian Institute of Public Health (NIPH). Helping clinicians on a national scale Kjell Tjensvoll, Team Leader for Helsebiblioteket said, ‘‘Providing frontline teams with easy access to the latest medical knowledge is vital in reducing unwarranted variation and improving patient care on a national scale. UpToDate Enterprise Edition enables this, and we are delighted to strengthen our relationship with Wolters Kluwer and provide continued support for clinicians across the country.’’ UpToDate Enterprise Edition was selected
Boyd Watterson Global Names John Creswell Global Chief Client Officer to Accelerate Global Growth and Client Engagement23.7.2026 15:00:00 CEST | Press release
Veteran investment management executive will lead global sales, client engagement and marketing as Boyd Watterson Global continues expanding its global alternatives platform across real estate, infrastructure, and debt strategies. Boyd Watterson Global today announced the appointment of John Creswell as Global Chief Client Officer, a newly created senior leadership role that reflects the firm's continued investment in growth and its evolution into a leading global alternatives investment platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722823117/en/ John Creswell has joined Boyd Watterson Global as Global Chief Client Officer, a newly created role overseeing global sales, client engagement and marketing across the U.S., Europe and APAC. In this role, Creswell will oversee global sales, client engagement and marketing efforts across the United States, Europe and APAC, helping investors access the firm's capabilitie
Trulioo Launches AI Agent to Resolve Beneficial Ownership Where Global Registries Fall Short23.7.2026 15:00:00 CEST | Press release
Breakthrough AI agent reconstructs ownership for long-tail businesses and hard-to-reach jurisdictions while significantly increasing UBO coverage Trulioo, a global risk intelligence platform, today announced the UBO Discovery Agent, the newest layer in Trulioo's UBO Discovery capability inside its business risk and Know Your Business (KYB) verification workflow. AI is reshaping fraud, making it easier for bad actors to hide, and harder for companies to catch them. This makes the already tough job of verifying who actually owns a business even more difficult. Determining a business's ultimate beneficial owner is an ongoing, acute challenge for companies: registry coverage is inconsistent across countries, and even where registries exist, they typically record shareholders and directors of record (rather than the people actually in control). That data isn't simply outdated, it reflects a structural lag: ownership changes and time passes before the filing is made and processed, so a looku
Humanoid Raises $152 Million at $1.35 Billion Post-Money Valuation, Becoming Europe's First Pure-Play Humanoid Robotics Unicorn23.7.2026 15:00:00 CEST | Press release
Humanoid announces its Series A investment round, reaching a $1.35 billion valuation just two years after founding.It is the largest ever Series A for a humanoid-first robotics company in Europe, positioning Humanoid as the leading humanoid-first robotics unicorn in the UK and continental Europe.The new capital will accelerate Humanoid's next-generation robot development, commercial deployments with global industrial leaders, and evolution of the proprietary AI platform on the path toward general-purpose humanoids.The investment marks a defining moment for Europe's tech ecosystem, showing that globally competitive Physical AI companies can be built and scaled in Europe. Humanoid, a UK-based AI and robotics company building industrial humanoid robots, announced a $152 million Series A financing at a $1.35 billion post-money valuation. This funding brings the total amount raised to date to $270 million. The round was led by Prime Movers Lab, a venture capital firm focused on investments
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