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Celcuity’s Phase 3 VIKTORIA-2 Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer Expanding to Include Endocrine-Sensitive Patients
Development of a gedatolisib formulation for subcutaneous injection is underway; first patent application submitted to the U.S. Patent and Trademark Office
About this update from Celcuity Inc.
[{"type":"text","content":"Development of a gedatolisib formulation for subcutaneous injection is underway; first patent application submitted to the U.S. Patent and Trademark Office\nMINNEAPOLIS, May 14, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced updates to the Phase 3 VIKTORIA-2 clinical trial of gedatolisib as a first-line treatment for patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”) locally advanced or metastatic breast cancer (“ABC”). Following last year’s announcement and subsequent data presentation demonstrating clinically meaningful improvement in progression-free survival (“PFS”) for patients treated with gedatolisib combined with palbociclib and fulvestrant compared to those treated with fulvestrant in the PIK3CA wild-type (“WT”) cohort of the VIKTORIA-1 Phase 3 study, several important elements of the VIKTORIA-2 clinical trial protocol have been amended. First, in addition to evaluating patients in the first-line setting with endocrine-resistant HR+/HER2- ABC, VIKTORIA-2 will now include a separate study to evaluate the safety and efficacy of patients in the first-line setting who have endocrine-sensitive HR+/HER2- ABC. Second, patients will be assigned manually according to their endocrine sensitivity status to either Study 1 (endocrine-resistant) or Study 2 (endocrine-sensitive) and subsequently be randomized to a treatment arm. Third, efficacy analyses for both Study 1 and Study 2 of VIKTORIA-2 will evaluate the entire intent-to-treat population (combined WT and mutant type (“MT”)) enrolled in their respective study. Each study will have independent statistical analysis plans that will include separate primary endpoints. The primary endpoints for the VIKTORIA-2 clinical trial are PFS, per RECIST 1.1 criteria, as assessed by blinded independent central review (“BICR”). Prior to finalizing the amended Phase 3 trial design, Celcuity conducted a Type B meeting with the U.S. Food and Drug Administration (the “FDA”) to obtain their feedback and to gain alignment on these planned amendments. “We are excited to expand the VIKTORIA-2 study to include patients with endocrine-sensitive HR+/HER2- ABC. For patients with endoc...