绿叶制药合作创新药Lurbinectedin(Zepsyre®)于世界肺癌大会发布临床进展
格隆汇获悉,近期在西班牙举行的世界肺癌大会上,绿叶制药(02186.HK)的合作伙伴PharmaMar向与会专家学者展示了在研新药Lurbinectedin(Zepsyre®)的临床研究新进展。此前,Lurbinectedin(Zepsyre®)已获FDA同意,可通过加速审评通道,申报用于小细胞肺癌二线单药治疗的新药申请(NDA)。目前,绿叶制药与PharmaMar在华合作开发该药物。
Lurbinectedin(Zepsyre®)是PharmaMar研发的海鞘素衍生物,为肿瘤创新药。绿叶制药拥有该药物在中国开发及商业化的独家权利,包括小细胞肺癌在内的所有适应症;并可要求PharmarMar进行该药物的技术转移,由绿叶制药在中国生产。
世界肺癌大会由国际肺癌研究协会主办,会集肺癌领域全球领先的专家学者,共同探讨与交流该疾病治疗的新进展、新趋势。此次大会上,Lurbinectedin(Zepsyre®)展示的临床数据包括:1)Lurbinectedin(Zepsyre®)联合紫杉醇或伊立替康治疗复发性小细胞肺癌的Ib期试验结果;2)完成最后一次铂剂化疗后≥30天复发的小细胞肺癌患者中Lurbinectedin(Zepsyre®)单药的抗肿瘤活性;此外,会上还就“转录”作为小细胞肺癌治疗靶点,以及Lurbinectedin(Zepsyre®)的作用机制进行探讨。
Lurbinectedin(Zepsyre®)的联合治疗
临床试验结果显示:Lurbinectedin(Zepsyre®)与紫杉醇或伊立替康的两种联合治疗的抗肿瘤活性相似,安全性可预测、可管理。其中,Lurbinectedin(Zepsyre®)与伊立替康的联用在三线治疗中显示出令人振奋的抗肿瘤活性。此外,Lurbinectedin(Zepsyre®)与紫杉醇联用在耐药患者中的抗肿瘤活性更高(CTFI < 90天:一线化疗用药结束至出现疾病进展的时间少于90天)。这些试验结果为进一步评估Lurbinectedin(Zepsyre®)与紫杉醇或伊立替康联合治疗提供了有效依据。目前,Lurbinectedin(Zepsyre®)与伊立替康联合治疗的扩展队列研究已在进行中。
Lurbinectedin(Zepsyre®)的单药治疗
试验结果显示:在84名CTFI ≥ 30(一线化疗用药结束至出现疾病进展的时间大于或等于30天)的患者中,总有效率(ORR)达到40.5%;CTFI 30-89天的耐药患者中,ORR达到29.2%,这类患者目前尚无可用的已批准的药物。对于60位敏感患者(CTFI ≥ 90天:一线化疗用药结束至出现疾病进展的时间大于或等于90天),ORR达到45%。此外,从该组患者的用药安全性来看,Lurbinectedin(Zepsyre®)的耐受性良好,安全性亦可接受,最常见的不良反应为中性粒细胞减少症,未观察到非预期毒性。
据悉,小细胞肺癌是比非小细胞肺癌侵袭性更强、更难治疗的一种肺癌类型,5年生存率仅为5%-10%。尽管小细胞肺癌对初始化疗和放疗具有较高的敏感性,但在初始治疗失败后,大多数患者最终死于复发转移,预后差。该领域的新药研发进展缓慢。2018年8月, Lurbinectedin(Zepsyre®)获得FDA授予的治疗小细胞肺癌的孤儿药资格,为治疗需求尚未满足的大量患者带来新的希望。
关于Lurbinectedin(Zepsyre®)
Lurbinectedin(Zepsyre®)是海鞘素衍生物,为RNA聚合酶II的抑制剂,能够与DNA双螺旋结构上的小沟共价结合,通过阻滞RNA聚合酶II与DNA的结合,并降解RNA聚合酶II的催化亚基RPB1,从转录的起始至延长阶段发挥抑制转录活性,使肿瘤细胞在有丝分裂过程中畸变、凋亡、最终减少细胞增殖。
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