重磅!全球首个登上国际顶级期刊JAMA的小细胞肺(4)
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