一次情報の記録
重要試験登録の変更
Lantern Pharma:FDAがType Cミーティングで LP-300のフェーズ2 HARMONIC試験の修正を承認
FDA raised no objections to three protocol amendments: (1) enrichment for EGFR exon 21 L858R patients, (2) extension of LP-300 dosing to eight cycles, and (3) transition to a single-arm design. These changes sharpen the regulatory path and partnering case for LP-300 in never-smoker NSCLC.
主要事実
- 提出
- 2026年5月19日 11:30
- イベント
- 試験登録の変更
- 方向
- ポジティブ
- アセット
- LP-300
- 信頼度
- 出典あり
- 治療関連重篤有害事象 LP-300
- 3%
- EGFR exon 21 L858R変異患者の無増悪生存期間中央値
- 8.3 months
- 安全性導入コホートの臨床的有用率
- 86%
- 安全性導入コホートの客観的奏効率
- 43%
- 治療関連重篤有害事象 amivantamab
- 23%
- LP-300のinfusion reaction
- 7%
- amivantamabのinfusion reaction
- 58%
出典の抜粋
Lantern Pharma Announces Successful Outcome of FDA Type C Meeting Request for HARMONIC(TM) Phase 2 Trial of LP-300 in Never-Smokers with NSCLC Lantern Pharma Announces Successful Outcome of FDA Type C Meeting Request for HARMONIC(TM) Phase 2 Trial of LP-300 in Never-Smokers with NSCLC Lantern Pharma Announces Successful Outcome of FDA Type C Meeting Request for HARMONIC™ Phase 2 Trial of LP-300 in Never-Smokers with NSCLC The FDA raised no objections to Lantern's key proposed protocol amendments to the HARMONIC™ clinical trial. Amendments include: (1) enriching enrollment for patients with EGFR exon 21 L858R mutations; (2) extending LP-300 dosing to a maximum of eight cycles; and (3) transitioning to a single-arm study design — changes that align with emerging data and support a cleare