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Celcuity reports gedatolisib triplet yields 11.1-month median PFS and 48.9% ORR in HR+/HER2- breast cancer trial, plans FDA submission
CELCCelcuity Inc.
Celcuity Inc. announced detailed efficacy and safety results from the PIK3CA mutant-type cohort of its Phase 3 VIKTORIA-1 clinical trial for gedatolisib in HR+/HER2- breast cancer. The gedatolisib-triplet demonstrated a median progression-free survival of 11.1 months and an objective response rate of 48.9%, compared to 5.6 months and 26.0% for alpelisib plus fulvestrant, respectively. The company plans to submit these data to the FDA as a supplemental New Drug Application.