OS Therapies宣布进行OST-HER 2的2b期试验，用于预防或延迟完全切除的肺转移性骨肉瘤的复发，OST-HER 2治疗患者的总生存期达到了2.5年的统计学显着益处

2026-06-02 18:07

75% 2.5-year overall survival for OST-HER2 vs. 47% pooled historical control (p = 0.003), with no new patient deaths reported since the 2-year overall survival data (75% vs. 60%, p = 0.034)
Updated clinical efficacy data being added to regulatory dossiers as Company seeks early market authorizations in U.S., U.K., Europe and Australia in 2nd half of 2026
EMA and Australia TGA (TGA) alignment achieved on early Q4-2026 3-year overall survival data, supported by biomarker data, as key approvable clinical efficacy endpoint
Upcoming U.S. FDA and U.K. MHRA meetings seek alignment with EMA and TGA on Phase 2b 3-year overall survival and biomarker data to support early market access
Confirmatory Phase 3 study, required to have commenced prior to grant of early market access in U.S., U.K., Europe or Australia, expected to initiate in late Q3-2026 in Australia