Celcuity’s Phase 3 VIKTORIA-1 trial achieves primary endpoint

Celcuity (CELC) announced positive topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with or without palbociclib in patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, PIK3CA mutant locally advanced or metastatic breast cancer, following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor. Detailed results will be presented in a late-breaking abstract oral session at the American Society of Clinical Oncology, or ASCO, Annual Meeting, taking place May 29-June 2. The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, or PFS, compared to alpelisib, a PI3Kalpha inhibitor, and fulvestrant. The secondary endpoint comparing gedatolisib plus fulvestrant versus alpelisib plus fulvestrant, which was not part of the primary efficacy analysis in the hierarchical order, also demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpelisib and fulvestrant. Both gedatolisib regimens were generally well tolerated, with manageable safety profiles, and no new safety signals. Celcuity intends to submit these data to the FDA as a supplemental New Drug Application and to submit VIKTORIA-1 data to other regulatory authorities following the sNDA submission.