Celcuity to Present Results from the Pivotal Phase 3 VIKTORIA-1 Trial at the 2025 European Society for Medical Oncology (ESMO) Congress
Rhea-AI Summary
Celcuity (NASDAQ:CELC), a clinical-stage biotech company, has announced that results from its pivotal Phase 3 VIKTORIA-1 trial will be presented at the 2025 ESMO Congress in October. The late-breaking presentation will focus on efficacy and safety data from the PIK3CA wild-type cohort, specifically examining gedatolisib plus fulvestrant with or without palbociclib versus fulvestrant in HR+/HER2- advanced breast cancer patients.
The presentation is scheduled for October 18, 2025, from 10:15 am to 11:45 am CEST, with the abstract number 3535. The late-breaking abstracts will be published on ESMO's website on the presentation day.
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MINNEAPOLIS, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that a late breaking abstract reporting clinical data from the Phase 3 VIKTORIA-1 trial has been selected for an oral presentation at the upcoming European Society of Medical Oncology (ESMO) Congress, being held October 17-21, 2025. The presentation will provide detailed efficacy and safety data from the PIK3CA wild-type cohort of the VIKTORIA-1 trial.
Late Breaking Oral Presentation Details:
Title: Gedatolisib + fulvestrant ± palbociclib vs fulvestrant in patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer: First results from VIKTORIA-1
Abstract Number: 3535
Session Title: Proffered paper session 1: Breast Cancer, metastatic
Date: October 18, 2025
Time: 10:15 am – 11:45 am CEST
Late-breaking abstracts (LBA) accepted for a Proffered Paper Session at the ESMO Congress 2025 will be published online via the ESMO website on the day of presentation.
About Celcuity
Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer (“ABC”) has completed enrollment of and reported topline data for the PIK3CA wild-type cohort, and is currently enrolling patients for the PIK3CA mutant cohort. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC is currently enrolling patients. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.
View source version of release on GlobeNewswire.com
Contacts:
Celcuity Inc.
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
(763) 392-0123
ICR Healthcare
Patti Bank, patti.bank@icrhealthcare.com
(415) 513-1284
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