Median OS was significantly longer in the serplulimab group （15.4 months， 95％ confidence interval [CI] 13.3-not evaluable） than in the placebo group （10.9 months， 95％ CI ） （hazard ratio [HR] 0.63, 95％ CI ； P <；；0.001）.The 24-month OS rate in the two treatment groups were 43.1％ and 7.9％， respectively. Median progression-free survival assessed by an independent radiology review committee per RECIST v1.1 was also longer in the serplulimab group compared to the placebo group （5.7 months vs. 4.3 months； HR 0.48, 95％ CI ）. Incidence of immune-related adverse events （irAEs） was similar to the approved PD-1/PD-L1 antibodies.

The success of ASTRUM-005 is a breakthrough in the treatment of ES-SCLC with PD-1 inhibitors. Based on the results of ASTRUM-005, the New Drug Application （NDA） of HANSIZHUANG in combination with chemotherapy for the first-line treatment of ES-SCLC has been accepted by the National Medical Products Administration （NMPA）. Furthermore， HANSIZHUANG has been recommended for the first-line treatment of ES-SCLC by the 2022 CSCO Guidelines for Diagnosis and Treatment of SCLC.

*图片素材来源于JAMA官网

ASTRUM-005研究的成功是PD-1抑制剂治疗ES-SCLC的重大突破，基于该项研究，国家药品监督管理局（NMPA）已受理H药一线治疗ES-SCLC适应症的上市申请；《CSCO小细胞肺癌诊疗指南（2022版）》也新增斯鲁利单抗联合化疗EC方案作为ES-SCLC一线治疗推荐，为中国ES-SCLC一线治疗提供了更多的选择。不仅如此，H药用于治疗SCLC于2022年4月获美国食品药品监督管理局（FDA）孤儿药资格认定。同时，基于FDA针对H药治疗ES-SCLC递交上市申请的正向反馈及FDA C类咨询会议的讨论结果，公司将在美国启动一项桥接临床试验，并拟于2024年Q1前在美国递交相应的上市申请。目前全球尚无一线治疗SCLC的抗PD-1单抗获批，H药有望成为全球首个一线治疗SCLC的抗PD-1单抗，填补未来五年PD-1抑制剂一线治疗小细胞肺癌的临床空白。

Henlius （2696.HK） is a global biopharmaceutical company with the vision to offer high-quality， affordable and innovative biologic medicines for patients worldwide with a focus on oncology， autoimmune diseases， and ophthalmic diseases. Up to date， 5 products have been launched in China， 1 approved for marketing in overseas markets， 13 indications approved worldwide， and 5 New Drug Applications （NDAs） accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&；；D， manufacturing and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice （GMP）， including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP.

文章来源：《世界临床药物》 网址: http://www.sjlcywzz.cn/zonghexinwen/2022/1009/2057.html