Clin Cancer Res:OX40激动剂Ivuxolimab在局部晚期或转移性癌症患者中的应用

2021-11-17 xiaozeng MedSci原创

Ivuxolimab 在在局部晚期或转移性癌症患者中具有良好的耐受性,并展示出了初步的抗肿瘤活性

效应 T 细胞刺激是肿瘤学中一种有吸引力的免疫治疗方法。 OX40 (CD134) 是一种在活化的 CD4+ 和 CD8+ T 细胞上表达的共刺激受体。抗原识别后诱导 OX40 导致 T 细胞活化、增殖和存活增强,并且 OX40 靶向在临床前研究中显示出了治疗效果。

Ivuxolimab (PF-04518600)是一种人 OX40 特异性的全人免疫球蛋白 G2 激动性单克隆抗体。本文报告了关于 Ivuxolimab 的一项多中心 I 期临床试验单药剂量递增部分的研究结果。

52 位筛选的局部晚期或转移性癌症成年人患者接受 0.01-10 mg/kg 的 Ivuxolimab 治疗。主要终点是安全性和耐受性。次要/探索性终点包括抗肿瘤活性的初始评估和生物标志物分析。

最常见的全因不良反应有疲劳(46.2%)、恶心(28.8%)和食欲减退(25.0%)。在31例治疗相关不良反应中,30例(96.8%)是2级或以下的。无剂量限制性毒性发生。Ivuxolimab 暴露量以剂量成比例的方式从 0.3 mg/kg 增加到 10 mg/kg。全外周血靶标参与发生在≥0.3 mg/kg。

不同给药剂量OX40的表达变化

3位(5.8%)患者获得了部分缓解,56%的患者获得疾病控制。在 0.1 mg/kg 至 3.0 mg/kg 给药剂量时观察到 CD4+ 中枢记忆 T 细胞增殖和活化增加,以及外周血中 CD4+ 和 CD8+ T 细胞的克隆扩增。在治疗中的肿瘤活检中,免疫细胞浸润和 OX40 表达均明显增加。

肿瘤进展与OX40表达的相关性

综上所述,Ivuxolimab 在临床相关剂量下的靶向免疫激活通常具有良好的耐受性,并展示出了初步的抗肿瘤活性,可作为联合方案研究的药物之一。

原始出处:

Adi Diab, Omid Hamid, John A. Thompson, et al. A Phase I, Open-Label, Dose-Escalation Study of the OX40 Agonist Ivuxolimab in Patients with Locally Advanced or Metastatic Cancers. Clin Cancer Res November 15 2021 DOI:10.1158/1078-0432.CCR-21-0845

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    2022-08-31 snf701207
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    2021-11-19 chg122
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    2021-11-18 学医无涯

    学习一下

    0