1차 출처 기록
결정급탑라인 결과
Immunome: 데스모이드 종양에서 varegacestat의 3상 RINGSIDE 시험 긍정적 톱라인 결과
등록 3상 RINGSIDE 시험이 1차 PFS 평가변수를 충족하였으며(HR 0.16, p<0.0001), ORR 56% 대 9%를 포함한 모든 주요 2차 평가변수도 충족하였습니다. Immunome은 이 데이터를 기반으로 2026년 2분기에 FDA에 NDA를 제출할 계획입니다.
핵심 사실
출처 발췌
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