原始来源记录
决策级顶线结果
Immunome：RINGSIDE III期试验varegacestat治疗韧带样瘤的顶线数据呈阳性
注册性III期RINGSIDE试验达到主要PFS终点（HR 0.16，p<0.0001），并达到所有关键次要终点，包括ORR 56%对比9%。Immunome计划基于这些数据于2026年Q2向FDA提交NDA。
关键事实
- 申报时间
- 2025年12月15日 12:05
- 事件
- 顶线结果
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- 日历
- FDA 审批决定 (PDUFA) · 2027年4月28日 · 积极
来源摘录
EX-99.1 2 d793961dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Immunome Announces Positive Topline Results from Phase 3 RINGSIDE Trial of Varegacestat in Patients with Desmoid Tumors Registrational trial met primary endpoint, with varegacestat significantly improving progression-free survival vs. placebo (hazard ratio = 0.16, p<0.0001) Trial also met all key secondary endpoints, with varegacestat delivering an objective response rate of 56% Varegacestat was generally well tolerated with a manageable safety profile New Drug Application submission to U.S. FDA planned for Q2 2026 Company to host conference call today at 8:30 a.m. ET BOTHELL, Wash., December 15, 2025 – Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted