赛诺菲/再生元的PD-1单抗Libtayo在基底细胞癌中显示出明显益处

2020-05-06 MedSci原创 MedSci原创

赛诺菲和再生元的PD-1单抗Libtayo(cemiplimab)在基底细胞癌(BCC)中显示出"临床上有意义且持久的反应",目前该疾病尚无批准的治疗方法。

赛诺菲和再生元的PD-1单抗Libtayo(cemiplimab)在基底细胞癌(BCC)中显示出"临床上有意义且持久的反应",目前该疾病尚无批准的治疗方法。

Libtayo

这两家公司发布了一项关键的单臂开放标签试验的主要数据,该试验中的晚期BCC患者对hedgehog抑制剂(HHI)的治疗后疾病进展或不耐受。

在该试验中,患有局部晚期BCC患者在Libtayo治疗后的客观缓解率(ORR)为29%,在85%的缓解者中,缓解持续时间(DOR)超过一年。持久的疾病控制率(DCR:缓解或至少持续6个月的稳定疾病)为60%。

尽管绝大多数的BCC都是早期发现的,并且可以通过手术或放射线治愈,但一小部分肿瘤会发展为晚期,并可更深地渗透到周围组织中(局部晚期),从而难以治疗。

Libtayo在2018年已经获得了美国在晚期皮肤鳞状细胞癌(CSCC)中的最初批准。

赛诺菲和再生元计划在2020年提交监管文件。

原始出处:

http://www.pharmatimes.com/news/sanofiregenerons_libtayo_shows_benefit_in_bcc_1339738

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