Core Insights - Celcuity Inc. announced promising overall survival data from a Phase 1b trial of gedatolisib in combination with palbociclib for patients with HR+, HER2- advanced breast cancer [1][2][3] Group 1: Clinical Trial Results - Median overall survival (OS) for treatment-naïve patients was reported at 77.3 months with a 95% confidence interval (CI) of 50.3 to 89.0 [2] - For patients previously treated with a CDK4/6 inhibitor, the median OS was 33.9 months with a 95% CI of 17.8 to 52.3 [2] - The results are favorable compared to existing first- or second-line standard-of-care regimens for the same patient population [3] Group 2: Mechanism and Development Strategy - Gedatolisib is a pan-PI3K/mTORC1/2 inhibitor that targets all Class I PI3K isoforms, potentially reducing drug resistance compared to isoform-specific inhibitors [4] - The clinical development strategy involves blocking multiple signaling pathways (ER, CDK4/6, and PAM) to enhance treatment efficacy [3] - Two Phase 3 clinical trials, VIKTORIA-1 and VIKTORIA-2, are planned to further evaluate this treatment strategy in HR+, HER2- advanced breast cancer [3][5] Group 3: Company Overview - Celcuity is a clinical-stage biotechnology company focused on targeted therapies for solid tumors, with gedatolisib as its lead candidate [5] - The company is currently enrolling patients for the VIKTORIA-1 trial and plans to begin the VIKTORIA-2 trial in Q2 2025 [5]
Celcuity Presents Overall Survival Data from Phase 1b Study Evaluating Gedatolisib in Combination with Palbociclib and Endocrine Therapy at the 2024 San Antonio Breast Cancer Symposium