一次情報の記録
決定級トップライン結果
Celcuity: PIK3CA変異を有するHR+/HER2- ABC患者において、gedatolisibレジメンはalpelisib+fulvestrantと比較してPFSを2倍に延長
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.
主要事実
- 提出
- 2026年6月2日 12:10
- イベント
- トップライン結果
- 方向
- ポジティブ
- アセット
- gedatolisib
- 出典
- SEC 8-K
- 信頼度
- 出典あり
- カレンダー
- FDA 審査決定 (PDUFA) · 2026年7月17日 · ポジティブ
- 2剤併用HR
- 0.33
- 3剤併用HR
- 0.24
- 対照群PFS
- 2.0ヶ月
- 2剤併用PFS中央値
- 7.4ヶ月
- 3剤併用PFS中央値
- 9.3ヶ月
出典の抜粋
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