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
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
(c) 2024 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
DATROWAY ® Type II Variation Application Validated in the EU as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who are Not Candidates for Immunotherapy18.12.2025 08:30:00 CET | Press Release
The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for DATROWAY® (datopotamab deruxtecan) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN). The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use. The application is based on data from the TROPION-Breast02 phase 3 trial presented in a late-breaking proffered paper session at the 2025 European Society for Medical Oncology (#ESMO25) Congress. In the trial, DATROWAY demonstrated statistically significant and clinical
Celltrion receives positive CHMP Opinion for SteQeyma™ (ustekinumab biosimilar) autoinjector18.12.2025 03:41:00 CET | Press Release
Celltrion, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of autoinjector of SteQeyma™, a biosimilar to Stelara® (ustekinumab), for the treatment of plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (CD). The positive CHMP opinion is for SteQeyma autoinjector in 45mg/0.5mL and 90mg/1mL, expanding the currently approved SteQeyma™ presentation, which includes 45mg/0.5mL, 90mg/1mL in a pre-filled syringe and 45mg/0.5mL in a vial for subcutaneous injection, as well as 130mg/26mL concentrate for solution for intravenous infusion. “The new SteQeyma™ autoinjector brings together convenience and practical usability to meet the everyday challenges faced by patients living with chronic inflammatory diseases. The full range of our SteQeyma™ dosage forms and strengths, with the autoinjector now added, provides patients and healthcare professionals with more individualized treatm
Megaport Expands into India, Accelerating Global Growth with Extreme IX Acquisition18.12.2025 02:15:00 CET | Press Release
Megaport Limited (ASX: MP1) (“Megaport”), the world’s leading Network as a Service (NaaS) provider, today announced the acquisition of Extreme IX,India’s leading Internet Exchange operator, from Extreme Labs, a Bulgaria-headquartered software and network engineering company that incubated the Extreme IX platform. The acquisition expands Megaport’s global platform into one of the world’s fastest-growing digital infrastructure markets and supports the Company’s strategy to deliver scalable, high-performance connectivity services across APAC. The acquisition establishes Megaport’s presence across seven Internet Exchanges in major Indian metros: Delhi, Kolkata, Hyderabad, Chennai, Bengaluru, Mumbai, and Pune, connecting 40+ data centres and more than 400 customers. It also accelerates Megaport’s planned market entry by nearly three years, while adding a seasoned in-country team spanning operations, support, sales, finance, and leadership to enable rapid integration and future growth. The E
Suzano Starts Up New Production Line, Boosting Its Fluff Pulp Capacity by 400%17.12.2025 21:50:00 CET | Press Release
Suzano, the world’s largest pulp producer, has commenced operations this week at its new fluff pulp production line located in its Limeira unit in Brazil’s São Paulo state. This R$490 million investment increases Suzano’s total fluff pulp production capacity by more than 400%, from 100,000 to 440,000 tonnes per year. The project involved converting the existing pulp line at the Limeira unit into a flexible machine, capable of producing both Eucafluff® and market pulp. Eucafluff® is used in the production of absorbent and personal hygiene products, such as baby and adult diapers, sanitary pads and pet pads. Then market pulp is supplied for making products including toilet paper, printing and writing papers, and paper packaging. Launched in 2015, Eucafluff® is the world’s first fluff pulp made from eucalyptus, delivering unique advantages like enhanced softness and flexibility, which translate into thinner, more discreet and comfortable products. Its high compression capability enables s
SES Acknowledges Moody’s Rating Action and Reiterates Deleveraging Commitments17.12.2025 21:36:00 CET | Press Release
SES S.A. (“SES” or the “Company”), a leading space solutions company, acknowledges the credit rating action announced by Moody’s Investor Service today, which follows the release of SES’ Q3 2025 results and Intelsat integration update. SES management reiterates that the Company continues to execute on its strategy with a clear plan to strengthen its key credit metrics over time. Consistent with this plan, it remains management’s intention to de-lever and return to credit metrics that are commensurate with investment grade, with a policy objective of reducing adjusted net leverage1 to at least 3.0x or below. Today’s rating action does not change the Company’s ability to operate its business, serve customers, or execute its strategic plan. SES maintains a balanced weighted average debt maturity profile of approximately five years, and the rating action from Moody’s is not expected to have a material impact on the interest payable under the Company’s existing debt facilities. SES also ben
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