一次情報の記録
決定級試験登録の変更
Lantern Pharma、HARMONIC試験をL858R NSCLCに焦点を当てるよう修正
FDAはLP-300の第2相HARMONIC試験の主要なプロトコル修正について異議を唱えなかった。登録はEGFR exon 21 L858R患者に集中し、単群デザインに切り替え、LP-300の最大治療期間を6サイクルから8サイクルに延長する。これらの修正は、L858Rサブグループにおける治療期間の延長でPFSの利益が深まるという新興データに基づいている。
主要事実
出典の抜粋
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