Celcuity provides update on status of PIK3CA mutant cohort

Celcuity (CELC) announced updates on the status of the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus alpelisib and fulvestrant in adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA mutant tumors, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. Median PFS and the objective response rate were assessed in sub-groups of patients according to their PIK3CA status. For all analyzed patients with PIK3CA MT tumor, median PFS was 14.6 months and the ORR in response evaluable patients was 48%. Median PFS was 19.7 months and the ORR was 64% in patients with PIK3CA MT tumors who received the intermittent dose of gedatolisib used in the VIKTORIA-1 study. For patients with PIK3CA WT tumors, median PFS was 9.0 months and the ORR in response evaluable patients was 41%. Median PFS was 9.1 months and the ORR was 53% in patients with PIK3CA WT tumors who received the intermittent dose of gedatolisib used in the VIKTORIA-1 study.