Gedatolisib doubles PFS vs alpelisib in PIK3CA mutant HR+/HER2- ABC Phase 3 trial

Celcuity Inc.

Gedatolisib-triplet reduced risk of progression or death by 50% (HR=0.50; p<0.0001); median PFS 11.1 vs 5.6 months.
ORR 48.9% for triplet vs 26.0%; median DOR 15.7 vs 7.5 months for alpelisib+fulvestrant.
Grade 3+ TRAEs: neutropenia 58.8% (triplet) vs 0.7%; discontinuation rate 2.6% vs 7.1%.
Company plans sNDA submission following positive PIK3CA MT cohort; PDUFA for NDA in WT cohort July 17, 2026.
Commercial launch expected in Q3 2026 pending FDA approval.

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