Clinical TrialMay 1, 2026, 05:05 PM
Celcuity's Gedatolisib Phase 3 VIKTORIA-1 Trial Positive in Breast Cancer
AI Summary
Celcuity Inc. announced positive topline results from the PIK3CA mutant cohort of its Phase 3 VIKTORIA-1 clinical trial for gedatolisib in HR+/HER2- advanced breast cancer. Both the gedatolisib triplet and doublet regimens demonstrated statistically significant and clinically meaningful improvements in progression-free survival compared to alpelisib plus fulvestrant, with manageable safety profiles. The company plans to submit these data to the FDA as a supplemental New Drug Application and to other regulatory authorities. Detailed results will be presented at the ASCO Annual Meeting in June 2026.
Key Highlights
- Gedatolisib triplet showed statistically significant PFS improvement vs alpelisib + fulvestrant.
- Gedatolisib doublet also showed statistically significant PFS improvement vs alpelisib + fulvestrant.
- Both gedatolisib regimens were generally well tolerated with manageable safety profiles.
- Celcuity intends to submit sNDA to FDA for PIK3CA mutant cohort data.
- Detailed results will be presented at ASCO Annual Meeting on June 2, 2026.
- FDA granted Priority Review for gedatolisib in PIK3CA wild-type ABC.
- PDUFA goal date for PIK3CA wild-type cohort is July 17, 2026.
- HR+/HER2- breast cancer accounts for approximately 70% of all breast cancers.