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BGB-900-103试验应答情况

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百济神州-自研+合作双轮驱动的全球化创新企业-211212（65页）.pdf

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多靶点受体酪氨酸激酶抑制剂 sitravatinib，联合替雷利珠单抗在多瘤种耐受且展现抗肿瘤活性。sitravatinib 是 Mirati 研发的一种在研用广谱选择性激酶抑制剂，可有效抑制受体络氨酸激酶，包括 RET、TAM 家族受体（TYRO3、Axl、MER）及断裂家族受体（VEGFR2、KIT），从而恢复肿瘤微环境的免疫应答。Mirati 正在对 sitravatinib 在治疗先前经过免疫检查点抑制剂治疗的难治性患者的多个临床试验中进行评估，已有的数据显示，在 PD-(L)1 疗法失效或不敏感的肿瘤中（NSCLC、膀胱癌、铂类耐药 OC），sitravatinib 和抗 PD-1 抗体联用观察到有意义的临床活性。2018 年 1 月，公司与 Mirati 就 sitravatinib 在亚洲（不包括日本及若干其他国家）、澳大利亚及新西兰的开发、生产及商业化订立独家授权许可协议。2018年 11 月，公司在澳大利亚和中国启动了 sitravatinib 与替雷利珠单抗联合用药用于治疗多种PD-1 敏感及不敏感的肿瘤类型（包括铂类耐药 OC） BGB-900-103 Ib 期临床试验（NCT03666143）。在 2021 年 ESMO 会议上，公司展示了此项研究治疗晚期 NSCLC 的临床数据，结果显示 sitravatinib 联合替雷利珠单抗在 PD-(1)初治患者和 PD-(L)1 难治性/耐药患者中均耐受性良好，并且展现了初步抗肿瘤活性，ORR 为 16.9%，DCR 为 84.5%，mPFS为 5.5 个月。此外，公司启动了一项 sitravatinib 单药及与替雷利珠单抗联合用药用于治疗HCC 和胃食管交界处癌患者的 BGB-900-104 I/II 期临床试验（NCT03941873）以及一项sitravatinib 联合替雷利珠单抗用于治疗鳞状和非鳞状 NSCLC 患者的 BGB-900-301 III期临床试验（NCT04921358）。竞争格局上，中国已有 2 款靶向 Axl 或 MER 的受体酪氨酸激酶抑制剂，此外还有 6 种候选药物处于临床研发阶段。

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