Clin Cancer Res:HER2双特异性抗体KN026单药治疗HER2+转移性乳腺癌的临床试验结果

2021-12-04 Nebula MedSci原创

HER2双特异性抗体KN026在转移性乳腺癌患者中的耐受性良好,治疗效果堪比曲妥珠单抗和帕妥珠单抗双重治疗

乳腺癌是全球女性最常发生的癌症。约15-20%的患者存在人表皮因子受体2(HER2/ERBB2)过表达或扩增,可从HER2靶向药物治疗中获益。

KN026是一种新型的双特异性的抗体,可同时结合HER2的两个不同的抗原表位。这是一项首次在人体中开展的I期试验,旨在评估KN026作为单药用于HER2阳性的转移性乳腺癌患者的安全性/耐受性、药代动力学、初始效果和潜在的预测生物标志物活性。

招募了既往接受抗HER2治疗后进展的HER2阳性的转移性乳腺癌患者,静脉予以KN026单药治疗:5 mg/kg (QW)、10 mg/kg (QW)、20 mg/kg (Q2W) 或30 mg/kg (Q3W)。

治疗相关的副反应

共招募了63位患者。最常见的治疗相关的副反应有发热(23.8%)、风险(22.2%)、天冬氨酸转氨酶升高(22.2%)、丙氨酸

转氨酶升高(22.2%)。只有4位患者报告了3级的治疗相关不良反应。

最佳治疗反应

暴露反应分析结果支持以 20 mg/kg (Q2W) 或 30 mg/kg (Q3W)作为推荐的2期剂量,以该剂量治疗时,57位患者的客观缓解率(ORR)达到了28.1%,中位无进展生存期(PFS)为6.8个月(95% CI 4.2-8.3)。

对20位存在HER2扩增的患者进行的转化研究进一步证实,HER2与CDK12同时扩增是预测患者对KN026治疗反应较好的潜在生物标志物(有 vs 无同时扩增:ORR 50% vs 0%; 中位PFS 8.2 vs 2.7个月;p=0.05和0.04)。

综上所述,HER2双特异性抗体KN026在转移性乳腺癌患者中的耐受性良好,治疗效果堪比曲妥珠单抗和帕妥珠单抗双重治疗。HER2/CDK12共扩增或可区分从KN026治疗中获益更多的患者。

原始出处:

Jian Zhang, Dongmei Ji, Li Cai, et al. First-in-human HER2-targeted Bispecific Antibody KN026 for the Treatment of Patients with HER2-positive Metastatic Breast Cancer: Results from a Phase I Study. Clin Cancer Res November 29 2021 DOI:10.1158/1078-0432.CCR-21-2827

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