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
Mainstay Medical Announces Two-Year Outcomes from RESTORE Clinical Trial of ReActiv8®3.9.2026 22:30:00 CEST | Press release
ReActiv8® Restorative Neurostimulation™ treatment group showed sustained improvements in measures of disability, pain and quality of life from the one-year to the two-year timepoints.83% of control group patients elected to cross over and receive ReActiv8 therapy after the one-year assessment.After one year of ReActiv8 therapy, the outcomes in the crossover group were indistinguishable from the treatment group at the same time point, confirming the effect is reproducible, robust, and not cohort specific. Mainstay Medical Holdings plc today announced the publication of the two-year assessment results from the RESTORE randomized clinical trial of ReActiv8 for the treatment of intractable chronic low back pain. The data show continued improvements in back pain-related disability, pain and quality of life in the ReActiv8 treatment group, and improvements after one year of ReActiv8 therapy in the crossover group that were indistinguishable from the improvements shown by the treatment group
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)3.9.2026 22:30:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to thirty-one newly hired non-executive employees. The equity awards were granted on September 1, 2026 and consisted of options to purchase an aggregate of 280,600 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 133,500 shares. The options have an exercise price per share equal to $13.24, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restr
Lenovo Advances Hybrid AI Across New Personal and Enterprise Technology3.9.2026 18:00:00 CEST | Press release
Lenovo announces expanded Lenovo and Motorola Qira experiences and availability, new Yoga, Idea, Think, and Motorola devices, and concepts that explore the next era of more personal, connected technology. Today at Lenovo™ Innovation World during IFA 2026, Lenovo unveiled a new portfolio of personal and enterprise technology, showing how its Hybrid AI strategy is moving from vision to practical experiences across devices, infrastructure, services, and the everyday moments that connect them. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260903555953/en/ Lenovo Innovation World at IFA 2026 The announcements bring together Lenovo’s “one personal AI, multiple devices” approach with enterprise technology that helps organizations turn data into insights and value. They span personal AI across PCs, smartphones, tablets, and wearables; creator and consumer devices that adapt to different ways of working and expressing ideas; and bus
Bahrain Signs its Participation Contract for Expo 2030 Riyadh3.9.2026 17:45:00 CEST | Press release
The Kingdom of Bahrain has signed its Participation Contract for Expo 2030 Riyadh, marking a new phase in preparations for its participation in the World Expo. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260903144412/en/ His Excellency Sheikh Khalifa bin Ahmed Al Khalifa, President of the Bahrain Authority for Culture and Antiquities, and Talal Al-Marri, Chief Executive Officer of Expo 2030 Riyadh, at the ceremony. The agreement provides the formal framework for Bahrain’s participation in Expo 2030 Riyadh, enabling preparations to advance across the key organizational and operational aspects of its presence throughout the six-month event, including the development of its pavilion, programmes and visitor experiences. The Participation Contract was signed in Bahrain by Talal Al-Marri, Chief Executive Officer of Expo 2030 Riyadh, on behalf of Expo 2030 Riyadh, and His Excellency Sheikh Khalifa bin Ahmed Al Khalifa, President
Kaltura and Verimatrix Partner to Strengthen Security for OTT and Cloud TV Services3.9.2026 17:45:00 CEST | Press release
Partnership combines Kaltura's Cloud TV platform with Verimatrix's content protection and anti-piracy solutions, with full migration of customers to be carried out in the coming months. Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260903384589/en/ Kaltura (Nasdaq: KLTR), the Agentic Digital Experience company, and Verimatrix (Euronext Paris: VMX), a leading provider of security solutions for a safer connected world, today announced a strategic partnership designed to provide enhanced protection for OTT and Cloud TV services. The partnership brings together Kaltura's scalable Cloud TV platform and Verimatrix's Digital Rights Management (DRM) and security capabilities. The joint solution, as part of Kaltura’s Marketplace, helps Telco’s, broadcasters, and media companies securely deliver premium live and on-demand content across a wide range of devices and operating systems. Demand for advanced content protec
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