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

Rhea-AI Summary

Incyte (NASDAQ: INCY) will present key oncology data at the ESMO Congress 2024 in Barcelona. Highlights include:

1. A Presidential Symposium featuring Phase 3 results for retifanlimab (Zynyz®) in squamous cell anal carcinoma (SCAC). These data will support a supplemental Biologics License Application (sBLA) filing planned by year-end 2024.

2. Initial Phase 1 data from a potential first-in-class CDK2 inhibitor program for CCNE1 ovarian and other advanced cancers.

3. An in-person analyst and investor event on September 14, 2024, to review key data, including new results from a later CDK2 data cut-off.

The presentations underscore Incyte's progress in developing treatments for areas with unmet medical needs.

Positive

• Phase 3 results for retifanlimab in SCAC to be presented at Presidential Symposium
• Planned sBLA filing for retifanlimab in SCAC by year-end 2024
• Initial Phase 1 data from potential first-in-class CDK2 inhibitor program to be presented
• CDK2 inhibitor shows potential for platinum-resistant ovarian and other cancers

Negative

• None.

Insights

Medical Research Analyst

The Phase 3 results for retifanlimab (Zynyz®) in squamous cell anal carcinoma (SCAC) are highly significant. This data, presented in a Presidential Symposium, will support an sBLA filing by year-end 2024, potentially accelerating the drug's approval process for this indication. SCAC is a rare cancer with treatment options, making this development particularly impactful.

The initial Phase 1 data for INCB123667, a potential first-in-class CDK2 inhibitor, is also noteworthy. CDK2 inhibition is an emerging approach in oncology, especially for CCNE1-amplified ovarian cancers, which are often resistant to standard therapies. This could represent a new treatment paradigm for a subset of difficult-to-treat cancers.

Financial Analyst

Incyte's upcoming presentations at ESMO 2024 could significantly impact its market position. The retifanlimab data, if positive, could lead to expanded market opportunities in SCAC. This rare cancer indication, while not a blockbuster market, could still provide meaningful revenue growth.

The CDK2 inhibitor program represents a potential new revenue stream in the competitive oncology space. If successful, it could diversify Incyte's portfolio and reduce reliance on existing products. However, it's important to note that this is early-stage data and the path to market is still long.

Investors should watch for the market's reaction to these presentations, as positive data could boost Incyte's stock price in the short term and improve long-term growth prospects.

- Presidential Symposium to feature Phase 3 retifanlimab (Zynyz^®) results in squamous cell anal carcinoma (SCAC); filing of supplemental Biologics License Application (sBLA) in SCAC planned by year end 2024

- Mini oral presentation to highlight initial Phase 1 data from potential first-in-class CDK2 inhibitor program in patients with CCNE1 ovarian and other advanced cancers

- Incyte to host an in-person analyst and investor event to review key data at ESMO, including new results from a later CDK2 data cut-off, on Saturday, September 14, 2024, from 1:00-2:30 p.m. ET (7:00-8:30 p.m. CEST)

WILMINGTON, Del.--(BUSINESS WIRE)-- 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/

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Source: Incyte

FAQ

What are the key presentations for Incyte (INCY) at ESMO Congress 2024?

Incyte will present Phase 3 results for retifanlimab in SCAC at a Presidential Symposium and initial Phase 1 data from their CDK2 inhibitor program for advanced cancers.

When does Incyte (INCY) plan to file the sBLA for retifanlimab in SCAC?

Incyte plans to file the supplemental Biologics License Application (sBLA) for retifanlimab in squamous cell anal carcinoma (SCAC) by year-end 2024.

What is the potential impact of Incyte's (INCY) CDK2 inhibitor program?

Incyte's CDK2 inhibitor program has the potential to enhance outcomes and serve as a foundational treatment for platinum-resistant ovarian and other cancers.

When and where will Incyte (INCY) host its analyst and investor event during ESMO 2024?

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) in Barcelona.