原始来源记录
决策级临床试验登记变更
Lantern Pharma 修改 HARMONIC 试验，聚焦 L858R NSCLC
FDA 已审查并对 LP-300 的 2 期 HARMONIC 试验关键方案修订未提出异议。入组将集中于 EGFR 外显子 21 L858R 患者，改为单臂设计，并将 LP-300 最大治疗周期从 6 个延长至 8 个。修订依据是新数据显示 L858R 亚组中更长治疗持续时间可带来更深的 PFS 获益。
关键事实
来源摘录
EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Lantern Pharma Reports Second Quarter 2026 Financial Results and Provides Business Update Open Medicine AI Established as a Separate Company with Executed Commercial Licenses; Progression-Free Survival Benefit Deepens in EGFR Exon 21 L858R Lung Cancer with LP-300; EMA Clears LP-184, zirdafulven, for Biomarker-Selected Bladder Cancer Trial; LP-184 Development Positioned to Advance in Multiple Indications including Triple Negative Breast Cancer and Pediatric Brain Cancers ● Open Medicine AI (OMAI) established as a separate company with board-approved commercial licensing agreements executed, operating the multi-agentic AI co-scientist platform previously launched as withZeta.ai. OMAI is currently wholly owned by Lantern and intends to raise capit