ペムブロリズマブとトラストズマブと,HER2陽性の胃または胃食道接合腺がんに対する化学療法:第3相KEYNOTE-811ランダム化プラセボ対照試験の暫定分析
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PubMedで要約を見る
まとめ
この要約は機械生成です。ペムブロリズマブとHER2阻害および化学療法との併用は,HER2陽性胃食道がんにおける無進行生存を著しく改善した. 全体生存データはまだ最終分析を待っています.
科学分野
- 腫瘍学
- 胃腸内科
- 免疫療法
背景
- HER2陽性胃食道がんにおける化学療法と併用されたPD- 1およびHER2阻害に関する証拠は限られている.
- 前回のKEYNOTE-811試験では,ペムブロリズマブとトラストズマブと化学療法による客観的な反応が優れていた.
研究 の 目的
- ステージ3のKEYNOTE-811試験の中間分析の結果を報告する.
- HER2陽性胃食道がんにおけるトラストズマブと化学療法との併用によるペムブロリズマブの有効性と安全性を評価する.
主な方法
- ランダム化され,ダブルブラインドで実施された第3相試験 (KEYNOTE-811) に698人の患者が参加した.
- 患者はペムブロリズマブまたはプラセボとトラストズマブと化学療法を受けた.
- 主なエンドポイントは,無進行生存率と全生存率でした.
主要な成果
- ペムブロリズマブは,第2の中間分析で,中位進行性生存期 (10. 0 vs 8. 1ヶ月; HR 0. 72; p=0,0002) を有意に改善しました.
- ペムブロリズマブ群の全生存期間の中央値は20. 0ヶ月,プラセボ群の16. 9ヶ月であり,第3の中間分析では統計的有意度には達しなかった.
- ペムブロリズマブを投与された患者の58%で,プラセボを投与された患者の51%で,グレード3以上の治療に関連する有害事象が発生しました.
結論
- ペムブロリズマブは,この患者集団において,進行性のない生存率を著しく改善した.
- 全体生存データについては,さらなる追跡が必要である.
- この組み合わせは管理可能な安全性プロファイルを示した.
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