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B細胞非ホジキンリンパ腫の再発または耐性のある患者における皮下エプコリタマブの投与量エスカレーション:オープンラベル,フェーズ1/ 2試験
Martin Hutchings1, Rogier Mous2, Michael Roost Clausen3
1Department of Haematology, Rigshospitalet, Copenhagen, Denmark.
Lancet (London, England)
|September 11, 2021
まとめ
Epcoritamabは,新しい双特異抗体であり,再発または耐性B細胞非ホジキンリンパ腫の治療に有望な安全性と有効性を示しています. 進行中の研究において,推奨される第2相48mgの投与量は,さらなる調査を必要とします.
科学分野:
- 腫瘍学
- 免疫学
- 薬理学について
背景:
- 再発または不耐性B細胞非ホジキンリンパ腫は,治療の選択肢が限られている.
- エプコリタマブは,CD3とCD20を標的にする新しい双特定抗体です.
- それはCD20+悪性B細胞に対するT細胞媒介の細胞毒性を誘発する.
研究 の 目的:
- エプコリタマブの安全性および推奨フェーズ2用量を決定する.
- エプコリタマブの抗腫瘍活性,薬動性,免疫バイオマーカーを評価する.
- 再発または耐性CD20+B細胞非ホジキンリンパ腫の患者でエプコリタマブを評価する
主な方法:
- 再発または耐性CD20+B細胞非ホジキンリンパ腫の成人を対象とした第1・2段階の投与量エスカレーション試験.
- エプコリタマブを28日サイクルで皮下投与する.
- 主要目的:最大許容量と推奨フェーズ2用量を決定する.次要目的:安全性,抗腫瘍活性,薬物動態,免疫バイオマーカー.
主要な成果:
- エプコリタマブの推奨フェーズ2用量は48mgで,投与量を制限する毒性は観察されなかった.
- 一般的な有害事象には,炎症 (69%) と注射部位反応 (47%) が含まれており,主にグレード1-2のサイトカイン放出症候群 (CRS) であった.
- 48 mgはDLBCLで88%のORRを示した.
結論:
- 単剤の皮下エプコリタマブは,好ましい安全性プロファイルと有意な抗腫瘍活性を示しています.
- 進行中のフェーズ2およびフェーズ3の研究において,推奨される48 mgのフェーズ2用量は,さらなる調査をサポートします.
- エプコリタマブはB細胞減少とT細胞活性化を誘発し,B細胞非ホジキンリンパ腫に対する有望な治療方法を示しています.
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