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
Day One Strategy Founders Recognised in The LDC Top 50 Most Ambitious Business Leaders for 20267.10.2026 20:00:00 EEST | Press release
Hannah Mann and Abigail Stuart, Co-Founders of Day One Strategy have been recognised as one of The LDC Top 50 Most Ambitious Business Leaders for 2026. The programme was created by private equity investor LDC, part of Lloyds Banking Group, in partnership with The Times. Since 2018, it has celebrated the ambition and achievements of hundreds of exceptional entrepreneurs. This year The LDC Top 50 attracted more than 620 nominations from across the UK, highlighting the depth of ambition among leaders building successful businesses in every region and sector. The leaders featured are driven by an appetite for growth that is helping to build stronger, more sustainable businesses and a more competitive UK economy. They are expanding internationally, developing new products and services, challenging established markets and investing in their people. Together, their businesses generate £1.4bn in annual revenues and employ almost 8,500 people. Headquartered in 55 towns and cities, they demonstr
TestMu AI Adds Evidence Packs to Kane CLI, Turning Every AI Test Run into One Portable, Shareable File7.10.2026 17:29:00 EEST | Press release
TestMu AI (formerly LambdaTest), the Full Stack Agentic AI Quality Engineering platform, announced evidence packs for Kane CLI, its terminal-first tool for natural language browser and mobile app testing. Every Kane CLI run now produces one sealed .evidence file that holds the complete record of what the AI agent was asked to do, what it did at each step, and what happened. Kane CLI launched in April 2026, giving developers and AI coding agents a way to run tests on real browsers and mobile apps from the terminal, in plain English, with a clear pass-or-fail verdict. Since launch, it has added AI-powered test case generation and the Assurance Lifecycle, which ties tests back to requirement documents. Evidence packs are the next step: a full record of every run. As AI agents write and run more tests, engineering teams need a clear answer to a simple question: what exactly did the agent do, and why did the run pass or fail? That proof is often spread across screenshots, log folders, and d
Medisca and EUROAPI Form Strategic Partnership to Strengthen API Access for Pharmaceutical Compounding7.10.2026 17:07:00 EEST | Press release
Medisca and EUROAPI have formed a strategic partnership focused on expanding API access for pharmaceutical compounding, creating differentiated access in North America and establishing a broader framework for international growth and peptide collaboration. For more than three decades, Medisca has built its business around the evolving needs of pharmaceutical compounders. That starts with the products it chooses to bring to market but extends much further to the manufacturers behind them, the documentation and technical information supporting them, and the quality systems that carry those products through to the customer. The partnership with EUROAPI advances that approach. Under the new strategic partnership, Medisca becomes EUROAPI’s first strategic distribution partner focused on bringing its European-manufactured APIs to the North American compounding market. The collaboration includes exclusive supply arrangements for selected APIs and creates a framework to expand the offering ove
iQmetrix Launches Vendor Managed Inventory Integration with Valor Communication7.10.2026 17:00:00 EEST | Press release
iQmetrix, the global provider of Intelligent Commerce Operating Systems for telecom, is launching a Vendor Managed Inventory integration with Valor Communication, a factory-direct wireless accessory manufacturer and distributor serving carriers, retailers, and dealers since 1997. Built into the iQmetrix Intelligent Commerce Operating System, the integration connects Valor's assortment directly to the platform telecom retailers already run their business on – so replenishment runs on real sell-through data instead of guesswork, and approved accessories move from Valor's floor to the peg without manual reordering. The integration will be available to retailers across the iQmetrix client base. The addition of Valor Communication marks another step in the rapid expansion of the iQmetrix Partner Ecosystem, bringing clients a growing network of integrated partners that work natively inside the platform they already run their business on. This press release features multimedia. View the full
Hightouch Names Matthew Lubeck General Manager, EMEA7.10.2026 16:40:00 EEST | Press release
Hightouch, the leader in data and AI for marketing, has named Matthew Lubeck General Manager, EMEA. Based in London, Lubeck will lead all of Hightouch's go-to-market functions across EMEA as the company helps brands in the region move to agentic marketing. Hightouch already has a strong foundation in Europe, with offices in London and Paris, and native-speaking teams in France, the German-speaking markets, Italy, the Nordics, Benelux, and the Middle East. It supports EU data residency and runs inside each customer's own data warehouse, so customer data never has to be copied into another platform. Brands across the region use Hightouch, including Accor, HelloFresh, Currys, Telenor, Salomon, Bolt, Nando's, and Depop. The company is also growing its Middle East presence, with a new team in Dubai focused on the UAE and Saudi Arabia. Lubeck's appointment follows more than 100 percent growth for Hightouch in each of the past two years, and its $150 million Series D earlier this year. Lubeck
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