Celcuity Inc. announced on July 24, 2025, that the first patient has been dosed in VIKTORIA-2, its Phase 3 clinical trial. This trial evaluates gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as a first-line treatment for patients with HR+/HER2- advanced breast cancer who are resistant to endocrine therapy.
The VIKTORIA-2 study is designed as an open-label, randomized clinical trial, aiming to enroll approximately 638 subjects at up to 200 clinical sites across North America, Europe, Latin America, and Asia. The primary endpoints are progression-free survival (PFS) in both PIK3CA wild-type and PIK3CA mutant cohorts.
This advancement into the front-line setting addresses a significant unmet need for patients whose disease has progressed on or after adjuvant endocrine treatment. Preliminary evidence from a Phase 1b trial showed a median progression-free survival of 48.6 months and an objective response rate of 79% for gedatolisib in a similar patient population, providing a strong rationale for this pivotal study.
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