石药集团(01093.HK):盐酸米托蒽醌脂质体注射液疗效数据令人惊喜
格隆汇12月18日丨石药集团(01093.HK)公布,由集团自主研发的盐酸米托蒽醌脂质体注射液(HE071)用于治疗复发/难治外周T细胞淋巴瘤(PTCL)和结外NK/T细胞淋巴瘤(ENKTCL)的有效性和安全性的临床研究数据摘要,于2020年美国血液学会(ASH)年会以口头汇报方式呈列。该研究为盐酸米托蒽醌脂质体注射液单药治疗(20mg/m2,每4周给药1次,最多6个周期(n=108))的关键性、单臂、多中心II期临床研究。
临床研究数据显示(截至2020年5月19日):其安全性较高,不良事件以血液学不良反应为主;入组的108例患者经IRC确认后的客观缓解率(ORR)、完全缓解(CR)率 及 疾 病 控 制 率(DCR)分 别 为40.7%(44/108)、20.4%(22/108)及69.4%(75/108)。 在98例效果可评估的患者中经IRC确认后的ORR、CR率及DCR分别为44.9%(44/98)、22.4%(22/98)及76.5%(75/98);生存方面的优势更加明显;NKTCL亚型(n=21)患者的疗效数据令人惊喜,经IRC确认后的ORR及DCR分别为 52.4%及76.2%。
据悉,盐酸米托蒽醌脂质体注射液为集团自主研发的2类新药,目前国内外暂无同剂型的产品上市或在研。集团已基于一项关键性注册II期研究于中国递交上市申请,2020年9月获得受理并进入优先审评通道。
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