Summit Therapeutics 计划 Q4 2025 为 ivonescimab 提交 BLA

Summit 宣布将基于 HARMONi 全球 III 期研究的阳性 PFS 结果（HR 0.52），于 Q4 2025 提交 BLA，寻求批准 ivonescimab 联合化疗用于 EGFR 突变 NSCLC 患者在 EGFR TKI 治疗后。该公司承认 FDA 对 OS 统计学显著性的要求，但认为当前的安全性和疗效数据支持批准，尽管 OS 趋势（HR 0.79，p=0.057）未达到显著性。

关键事实

申报时间: 2025年10月20日 11:28
事件: 申请已提交
方向: 积极
公司: SMMTSummit Therapeutics
资产: ivonescimab
来源: SEC 8-K
可信度: 有来源
OS HR: 0.79
PFS HR: 0.52
OS 中位数: 16.8 vs 14.0个月
PFS 中位数: 6.8 vs 4.4个月

来源摘录

EX-99.1 2 a2025_prx1020xq32025earn.htm EX-99.1 a2025_prx1020xq32025earn 1 Summit Therapeutics Reports Financial Results and Operational Progress for the Third Quarter and Nine Months Ended September 30, 2025 Summit Plans to Submit a BLA in Q4 2025 for Ivonescimab based on HARMONi Global Phase III Study Results Expansion of Summit’s Global Phase III Development Program Starts with Initiation of HARMONi-GI3, a New Study in 1L CRC: Summit to Initiate an Additional Set of Phase III Clinical Trials with Details to Come in Q1 2026 Ivonescimab with Chemotherapy Reduces the Risk of Disease Progression or Death by 48% Compared to Chemotherapy Alone in Global Phase III HARMONi Trial Evaluating Patients with EGFRm NSCLC after EGFR TKI Therapy with Consistent Data across Regions Ivonescimab with Che

SEC 8-K