智通财经APP获悉，百时美施贵宝(BMY.US)宣布，美国FDA已接受为重磅免疫组合疗法Opdivo(nivolumab)联合Yervoy(ipilimumab)递交的补充生物制品许可申请(sBLA)，一线治疗不可切除或转移性微卫星不稳定性高(MSI-H)或错配修复缺陷(dMMR)结直肠癌(mCRC)成年及儿童(12岁及以上)患者。FDA已授予该申请突破性疗法认定和优先审评资格，预计在2025年6月23日之前完成审评。
在今年1月底公布的分析结果显示，在中位随访时间为47个月时，接受Opdivo联合Yervoy治疗的患者，与Opdivo单药疗法相比，疾病进展或死亡风险降低38%。在12、24和36个月时，Opdivo联合Yervoy的无进展生存率分别为76%、71%和68%，均高于Opdivo单药疗法的63%、56%和51%。
此外，Opdivo联合Yervoy的客观缓解率(ORR)为71%，显著高于Opdivo单药疗法(58%，p=0.0011)。此前发布的结果显示，与研究者选择的化疗相比，Opdivo联合Yervoy作为一线疗法，可将疾病进展或死亡的风险降低79%。
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