1차 출처 기록
결정급탑라인 결과
Celcuity: PIK3CA 변이 HR+/HER2- 진행성 유방암에서 Gedatolisib 병용요법이 alpelisib+fulvestrant 대비 PFS 2배 개선
The Phase 3 VIKTORIA-1 PIK3CA-mutant cohort topline results show gedatolisib plus fulvestrant with or without palbociclib achieved statistically significant PFS improvements (HR 0.50 and 0.51) versus alpelisib plus fulvestrant. Celcuity plans to file an sNDA with these data and anticipates potential FDA approval in Q3 2026.
핵심 사실
출처 발췌
EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Celcuity’s Gedatolisib Combination Regimens Doubled the Likelihood of Survival without Disease Progression or Death Compared to Alpelisib plus Fulvestrant in the PIK3CA Mutant Cohort of the Pivotal Phase 3 VIKTORIA-1 Trial in Patients with HR+/HER2- Advanced Breast Cancer ● Gedatolisib plus fulvestrant and palbociclib (the “gedatolisib-triplet”) reduced the risk of disease progression or death by 50% vs. alpelisib plus fulvestrant (HR=0.50; 95% CI: 0.37–0.68; p<0.0001). Median progression-free survival (“PFS”) was 11.1 months with the gedatolisib triplet versus 5.6 months with alpelisib plus fulvestrant ● Gedatolisib plus fulvestrant (the “gedatolisib-doublet”) reduced the risk of disease progression or death by 49% vs. alpelisib plus fulvestr