BMS的PD-1单抗Opdivo:未能在III期临床改善多形性胶质母细胞瘤患者的无进展生存期

2019-09-05 不详 MedSci原创

Bristol-Myers Squibb宣布,在新诊断为O6-MGMT甲基化的多形性胶质母细胞瘤患者中,将Opdivo(nivolumab)加入标准治疗未能显着改善无进展生存期(PFS)。该公司表示将继续观察III期临床试验CheckMate-548整体生存率(OS)的数据。

Bristol-Myers Squibb宣布,在新诊断为O6-MGMT甲基化的多形性胶质母细胞瘤患者中,将Opdivo(nivolumab)加入标准治疗未能显着改善无进展生存期(PFS)。该公司表示将继续观察III期临床试验CheckMate-548整体生存率(OS)的数据。

该研究将新诊断的MGMT甲基化多形性胶质母细胞瘤患者随机分组,以接受目前的标准治疗莫唑胺联合放疗,单独或与Opdivo联合使用。该试验的主要终点是PFS。

Opdivo目前已被批准用于多种适应症,包括肝细胞癌、转移性黑素瘤、非小细胞肺癌NSCLC)和肾细胞癌,第二季度PD-1免疫检查点抑制剂的销售额达到18亿美元。

今年早些时候,Bristol-Myers Squibb 发布了Opdivo在NSCLC中的混合晚期结果,该疗法在CheckMate -227研究的第2部分中缺少OS的主要终点。同时,该公司同时指出,在试验的第1a部分中,Opdivo与Yervoy(ipilimumab)联合使用可显着延长OS。

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    2019-09-22 juliusluan78
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    2019-09-07 119337457
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    2019-09-07 canlab

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今年伊始,随着三个国产PD-1单抗相继在市场上的强势进入,竞争格局正在变得越来越激激烈。

晚期食管鳞癌一线PD-1单抗联合化疗获良效

晚期食管癌一线治疗推荐含铂为基础的联合化疗方案,但化疗有效率相对较低,且患者耐受性较差。近期PD-1单抗帕博利珠单抗已经获批用于晚期食管癌二线或以上治疗,且在一线化疗失败后的食管癌中,多个PD-1单抗对比化疗,均可显着延长总生存期(OS)。目前在国内,多项PD-1单抗用于晚期食管癌一线治疗的临床试验正在进行中,结果令人期待。本次分享的这例晚期食管鳞癌患者,合并症较多,对含铂双药化疗的耐受性相对较差

第三个国产PD-1单抗正式获批

今日(5月31日),根据国家药监局行政事项综合查询网站的更新,恒瑞医药自主研发的PD-1单抗注射用卡瑞利珠单抗的审批状态已经更新为“审批完毕-待制证”,这意味着,卡瑞利珠单抗(SHR-1210,商品名为艾立妥)正式在国内获批,用于至少经过二线系统化疗的复发或难治性经典型霍奇金淋巴瘤患者的治疗,这也是第三个获批上市的国产PD-1单抗药物。