基石药业-B(02616.HK)BLU-667全球I期注册性研究完成首例中国患者给药
格隆汇8月12日丨基石药业-B(02616.HK)宣布,由公司合作伙伴Blueprint(纳斯达克股份代号:BPMC)开发的BLU-667于其I期注册性研究中完成首例中国患者给药。此次临床试验是正在进行的全球I期ARROW研究的一部分,旨在评估BLU-667在RET变异的非小细胞肺癌、甲状腺髓样癌或其他晚期实体瘤患者中的总体缓解率("ORR")、缓解持续时间、药代动力学、药效学和安全性。
肺癌是全球发病率及病死率最高的恶性肿瘤。中国受环境污染及高吸烟率等高风险因素的影响,每年约有73万例新发肺癌病例和61万例肺癌相关死亡病例。非小细胞肺癌占所有肺癌的80%至85%,而RET融合在非小细胞肺癌中的发生率约为1%至2%。对于RET融合的非小细胞肺癌的一线标准治疗为含铂双药化疗,二线治疗为细胞毒药物或免疫检查点抑制剂的单药治疗,但疗效均不理想。因而,患者遭受巨大的生理及心理痛苦,生活品质下降。
甲状腺癌是最常见的内分泌癌症,近几年发病率呈现上升。中国每年约有9万例甲状腺癌新发病例和6800例甲状腺癌相关死亡病例。甲状腺髓样癌占所有甲状腺癌的2%至5%,几乎所有遗传性甲状腺髓样癌患者和约50%的散发性甲状腺髓样癌患者均伴有RET基因突变。目前,中国甲状腺髓样癌患者尚无有效的获批标准治疗方案。
BLU-667是一种口服、高选择性和强效的RET抑制剂。2018年6月,基石药业自Blueprint获得了包括BLU-667在内的三种药物在中国大陆、香港、澳门和台湾的独家开发和商业化授权。Blueprint保留这三款药物在世界其他地区的开发和商业化权利。
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