Celcuity’s Gedatolisib Triplet Yields Clinically Meaningful PFS Boost in PIK3CA Mutant Cohort
Celcuity’s Phase 3 VIKTORIA-1 trial in PIK3CA mutant HR+/HER2- breast cancer met its primary endpoint, demonstrating statistically significant progression-free survival improvements for the gedatolisib triplet versus alpelisib plus fulvestrant. The gedatolisib doublet also showed significant PFS gains, and Celcuity plans an FDA supplemental NDA submission.
1. Trial Design and Patient Cohort
Celcuity’s VIKTORIA-1 is a Phase 3 open-label, randomized trial in HR+/HER2-, PIK3CA mutant advanced breast cancer patients whose disease progressed on CDK4/6 inhibitors and aromatase inhibitors. Patients were assigned to gedatolisib plus fulvestrant with or without palbociclib versus alpelisib plus fulvestrant.
2. Efficacy Results
The primary analysis showed the gedatolisib triplet achieved a statistically significant and clinically meaningful progression-free survival improvement versus alpelisib plus fulvestrant, while the gedatolisib doublet also demonstrated significant PFS gains in the PIK3CA mutant cohort.
3. Safety Profile
Both gedatolisib regimens were generally well tolerated, with manageable adverse events and no new safety signals identified compared to the control arm.
4. Regulatory Next Steps
Celcuity intends to submit a supplemental NDA to the FDA based on these topline results and plans to pursue regulatory filings in additional jurisdictions, leveraging the positive VIKTORIA-1 data for both PIK3CA mutant and wild-type cohorts.