重磅!全球首个登上国际顶级期刊JAMA的小细胞肺(3)
ASTRUM-005是一项在既往未接受过治疗的ES-SCLC患者中比较H药联合化疗及安慰剂联合化疗的临床有效性和安全性的随机、双盲、国际多中心、Ⅲ期临床研究,在中国、土耳其、欧盟波兰、格鲁吉亚等多个国家共开设128个试验中心,其中114个试验中心有受试者参与了筛选,共入组585例受试者,约31.5%为白人。截至2021年10月22日,本研究共入组的斯鲁利单抗组(n=389)和安慰剂组(n=196)中位随访时间为12.3个月。斯鲁利单抗组和安慰剂组的中位OS分别为15.4个月(95% CI 13.3–NE)和10.9个月(95% CI 10.0–14.3),风险比(HR)为0.63(95% CI 0.49–0.82;p<;;0.001)。两组的24个月总生存率分别为43.1%和7.9%。斯鲁利单抗组及安慰剂组经独立影像评估委员会(IRRC)依据RECIST v1.1评估的中位PFS分别为5.7和4.3个月(HR 0.48,95% CI 0.38–0.59)。安全性方面,斯鲁利单抗组的免疫相关不良事件(irAEs)发生率与已获批的PD-1/PD-L1单抗相似。
HANSIZHUANG was approved by the NMPA for the treatment of MSI-H solid tumours in March 2022 and its synergy with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 11 clinical trials on immuno-oncology combination therapies in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 3,100 subjects in China, Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The NDAs of the first-line treatment for squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC) have been accepted by the NMPA, which makes HANSIZHUANG potentially the world's first anti-PD-1 mAb for the first-line treatment of SCLC. Furthermore, HANSIZHUANG was recommended by the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (SCLC) for the treatment of ES-SCLC, and the related clinical trial has also become the first study published in JAMA on SCLC immunotherapy. Serplulimab was also granted orphan drug designation by the FDA for treatment of SCLC.
Providing more treatment options for patients worldwide
2022年9月27日,由程颖教授牵头的国际多中心研究——ASTRUM-005研究在全球四大顶级医学期刊之一的《美国医学会杂志》(JAMA,影响因子:157.3)在线发表,成为全球首个登上JAMA主刊的小细胞肺癌免疫治疗临床研究。ASTRUM-005研究是复宏汉霖自主研发的抗PD-1单抗H药 汉斯状?(斯鲁利单抗)联合化疗一线治疗广泛期小细胞肺癌(ES-SCLC)的Ⅲ期临床研究,2022年ASCO年会程颖教授首次报告结果后,引起了全球同行的广泛关注,而今再度登上国际顶级学术舞台,体现了国际学术界的高度认可,彰显出中国研究者的智慧化和生物医药领域国际一流的自主创新实力和临床运营能力。
In April 2022, the US Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for HANSIZHUANG for the treatment of SCLC. Based on the positive feedback from FDA Biologics License Application (BLA) submission for HANSIZHUANG for the treatment of ES-SCLC and the discussion on the FDA's Type C consultation meeting, Henlius is planning to soon carry out a bridging study in the US and expected to submit BLA to FDA before Q1 of 2024. At present, there is no anti-PD-1 mAb approved for the first-line treatment of SCLC worldwide. HANSIZHUANG is expected to become the world's first anti-PD-1 mAb for the first-line treatment of SCLC and to fill the clinical gap in the next five years.
关于H药 汉斯状?
Cheng Y, Han L, Wu L, et al. Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer:The ASTRUM-005 Randomized Clinical ;328(12):1223–1232. doi:10.1001/
关于JAMA
通讯作者与第一作者、ASTRUM-005研究主要研究者、吉林省肿瘤医院程颖教授表示:
ASTRUM-005 is a randomised, double-blind, international, multi-centre, phase 3 clinical study that aims to compare the efficacy and safety of HANSIZHUANG with placebo when combined with chemotherapy in previously untreated patients with ES-SCLC. ASTRUM-005 has set up a total of 128 sites in various countries including China, Turkey, Poland, and Georgia, and enrolled 585 subjects who were screened from 114 sites, among whom 31.5% were White. As of data cutoff for this interim analysis (October 22, 2021), 585 eligible patients were randomised (serplulimab group, n=389; placebo group, n=196), with a median follow-up duration of 12.3 months.
文章来源:《世界临床药物》 网址: http://www.sjlcywzz.cn/zonghexinwen/2022/1009/2057.html