百时美施贵宝(BMY.US)周二表示，美国食品药品管理局(FDA)已批准其重磅PD-1抑制剂Opdivo(nivolumab)联合CTLA-4靶向抗体Yervoy(ipilimumab)用于治疗微卫星高度不稳定(MSI-H)或错配修复缺陷(dMMR)表型的转移性结直肠癌(mCRC)成人和儿童患者。

百时美施贵宝在1月底公布了3期临床试验CheckMate-8HW的分析结果。该研究评估了Opdivo联合Yervoy，对比研究者选择的化疗(mFOLFOX-6或FOLFIRI方案，联合或不联合贝伐珠单抗或西妥昔单抗)用于治疗微卫星高度不稳定(MSI-H)或错配修复缺陷(dMMR)表型的转移性结直肠癌(mCRC)患者。分析显示，在中位随访47个月时，接受Opdivo联合Yervoy治疗的患者在所有治疗线中，相较于Opdivo单药疗法，疾病进展或死亡的风险降低了38%。此前，CheckMate-8HW试验的结果显示，相较于研究者选择的化疗，Opdivo联合Yervoy可将疾病进展或死亡的风险降低79%。

Opdivo是一种PD-1免疫检查点抑制剂，旨在帮助恢复抗肿瘤免疫反应，利用人体自身的免疫系统来对抗癌症。Yervoy则靶向抑制CTLA-4，CTLA-4抗体通过增强T细胞活性来提高肿瘤杀伤能力;该产品已于2011年获得美国FDA批准治疗晚期黑色素瘤，是全球首个获批上市的CTLA-4抗体药物。

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