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在患有高级固体恶性瘤的患者中进行皮下阿米万塔马布输送:Ib期PALOMA研究

Anna Minchom¹, Byoung Chul Cho², Natasha B Leighl³

¹Drug Development Unit, Royal Marsden/Institute of Cancer Research, Sutton, Surrey, UK.

Clinical lung cancer

|March 10, 2026

概括

皮下使用的amivantamab可显著减少与输液相关的反应和注射时间,而对于晚期非小细胞肺癌 (NSCLC) 进行静脉注射相比. 这种新配方消除了分剂的需要,提高了患者的方便和安全.

科学领域:

在瘤学瘤学.
药理学药理学是指药理学的学科.
免疫治疗是一种免疫疗法.

背景情况:

阿米万塔马布是一种经批准的对EGFR突变NSCLC双特异性抗体.
静脉注射阿米万塔马布与输注相关反应 (IRR) 有关,需要延长输注时间.
在PALOMA研究中,研究了皮下注射的amivantamab,以改善管理和安全性.

研究的目的:

评估皮下注射amivantamab的安全性和可行性.
为了确定各种皮下注射剂量计划的推二期剂量 (RP2Ds).
评估皮下注射对输液相关反应和注射时间的影响.

主要方法:

一项Ib期,剂量升级研究 (PALOMA) 涉及158名患有晚期固体恶性瘤的参与者.
主要目标包括药理动力学分析,安全性评估和每2周 (Q2W),每3周 (Q3W) 和每4周 (Q4W) 时间表的RP2D确定.
对安全性资料进行了比较,以往的静脉注射amivantamab数据.

主要成果:

皮下使用的amivantamab显示出与静脉注射相一致的安全性,毒性反映了目标EGFR/MET抑制.
皮下用amivantamab的施用时间显著缩短 (≤10分钟),IRR的频率和严重程度较低.
建立了Q2W,Q3W和Q4W皮下注射方案的RP2D,观察到的疗效与静脉注射amivantamab单一治疗一致.

结论:

皮下使用amivantamab可大大降低IRR,并消除了长时间注射和分剂量的需要.
已识别的皮下阿米万塔马布RP2D将用于正在进行的NSCLC和其他癌症的研究.
这种配方为接受amivantamab治疗的患者提供了更方便和潜在的更安全的替代方案.

关键词:

欧洲农业基金会 (EGFR) 是一个.非小细胞肺癌是什么?药理动力学药理动力学固体瘤是一种固体瘤.皮下使用的有机物.

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