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百济神州PD-1单抗Tislelizumab治疗肝细胞癌的新药申请被NMPA接受,以及Tislelizumab抗肿瘤临床研究汇总

2020-07-03 MedSci原创 MedSci原创

“世界上一半的肝癌患者都居住在中国,医疗需求仍未得到满足。”

百济神州宣布,中国国家药品监督管理局(NMPA)的药物评估中心(CDE)已接受百济神州的抗PD-1单抗替雷利珠单抗的补充新药申请(sNDA),用于先前已治疗的不可切除的肝细胞癌(HCC)(最常见的肝癌形式)患者的治疗。

See the source image

中国总经理兼百济神州总裁吴晓斌博士说:“我们对替雷利珠单抗在肝癌中的首次申请被接受感到非常兴奋。世界上一半的肝癌患者都居住在中国,医疗需求仍未得到满足。我们将继续与CDE保持联系,并希望在不久的将来为这些患者提供可行的治疗选择。”

sNDA的申请基于在先前接受过治疗的不可切除HCC患者中,开展的2期临床试验(NCT03419897)结果的支持。该研究招募了来自亚洲和欧洲八个国家和地区的249例不可切除的HCC患者,患者接受tislelizumab单药治疗(每三周200毫克)。该试验的主要终点是由独立审核委员会(IRC)评估的客观缓解率,结果将在即将举行的医学会议上发表。

关于替雷利珠单抗

Tislelizumab(BGB-A317)是人源化IgG4抗PD-1单克隆抗体,经过专门设计以最大程度减少与巨噬细胞上FcγR的结合。在临床前研究中,已证明与巨噬细胞上的FcγR结合会激活抗体依赖性巨噬细胞介导的T效应细胞杀伤作用,从而损害PD-1抗体的抗肿瘤活性。

Tislelizumab已获得中国国家药品监督管理局(NMPA)的批准,用于接受至少两次既往治疗的经典霍奇金淋巴瘤患者,以及高表达PD-L1、含铂化疗期间或之后或在新辅助或含铂化疗辅助治疗的12个月内进展的局部晚期或转移性尿路上皮癌(UC)患者。

替雷利珠单抗的临床试验包括:

  • 替雷利珠单抗治疗局部晚期或转移性尿路上皮癌患者的3期试验(NCT03967977);
  • 比较替雷利珠单抗和多西他赛作为NSCLC二线或三线治疗的3期试验(NCT03358875);
  • 替雷利珠单抗联合化疗作为晚期鳞状NSCLC患者的一线治疗的3期试验(NCT03594747);
  • 替雷利珠单抗联合化疗作为晚期非鳞状非小细胞肺癌一线治疗的3期试验(NCT03663205);
  • 替雷利珠单抗联合铂类双线化疗作为NSCLC患者新辅助治疗的3期试验(NCT04379635);
  • 替雷利珠单抗联合铂类化疗和依托泊苷治疗广泛期小细胞肺癌患者的3期试验(NCT04005716);
  • 比较替雷利珠单抗和索拉非尼作为肝细胞癌一线治疗的3期试验(HCC; NCT03412773);
  • 替雷利珠单抗用于先前接受过不可切除肝癌治疗的2期临床试验(NCT03419897);
  • 比较替雷利珠单抗和化疗作为晚期食管鳞状细胞癌二线治疗的3期试验(ESCC; NCT03430843);
  • 替雷利珠单抗联合化学疗法作为ESCC一线治疗的3期试验(NCT03783442);
  • 替雷利珠单抗与放化疗联合治疗局部ESCC的3期试验(NCT03957590);
  • 替雷利珠单抗联合化疗作为胃癌患者一线治疗的3期试验(NCT03777657);
  • 替雷利珠单抗治疗MSI-H/dMMR实体瘤患者的2期试验(NCT03736889);
  • 替雷利珠单抗联合化疗作为鼻咽癌患者一线治疗的3期试验(NCT03924986)。

原始出处:

https://www.firstwordpharma.com/node/1737235?tsid=4

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    2020-09-18 xjy02
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    2020-07-03 mswert122

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