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邹德慧教授:Zanubrutinib在套细胞淋巴瘤(MCL)等多种B细胞淋巴瘤中应用前景广阔,成为我国自主研发药的重大里程碑

2018-12-29 佚名 肿瘤资讯

2018年12月22日,第二届百济神州血液肿瘤高峰论坛在江城武汉隆重召开。由百济神州自主研发的新型BTK抑制剂Zanubrutinib在众多血液肿瘤中的应用进展成为备受关注的热点。

2018年12月22日,第二届百济神州血液肿瘤高峰论坛在江城武汉隆重召开。由百济神州自主研发的新型BTK抑制剂Zanubrutinib在众多血液肿瘤中的应用进展成为备受关注的热点。

BGB-3111-206研究:Zanubrutinib单药治疗复发/难治MCL,CR高达59%

作为BGB-3111-206临床研究的主要研究者之一,我有较多的真实体会。BGB-3111-206是一项在中国开展的关键、单臂、多中心Ⅱ期研究。该临床试验的主要目的是探讨Zanubrutinib 单药对一线以上复发/难治的MCL(R/R MCL)患者的疗效及安全性,其结果在前不久刚刚结束的ASH会议进行了报告,并引起广泛关注。在85例可评价疗效的患者中,经过独立审查委员会(IRC)评估的总有效率(ORR)为84%,高达59%的患者获得了完全缓解(CR)。同时在获得治疗反应的患者中,估计24周无事件反应率为90%;随访24周时,患者无进展生存率(PFS)约为82%。

Zanubrutinib结构优化,疗效和安全性优势凸显

Zanubrutinib作为新型BTK抑制剂,与一代BTK抑制剂Ibrutinib存在结构上的差异,其中最主要的区别为Ibrutinib是含嘧啶环的ATP结构类似物,而Zanubrutinib是不含嘧啶环的新型BTK抑制剂。Zanubrutinib结构的改变使其抑制BTK的同时对EGFR,TEC,ITK,HER-2等其他激酶没有明显的抑制或明显提高其抑制作用的IC50值,使其对这些激酶的抑制能力减低,因此脱靶效应也明显降低。我们都知道,一代BTK抑制剂除了抑制BTK的作用以外,比较常见的副作用就是针对其他激酶的脱靶效应。

另外,研究发现Zanubrutinib作为新型BTK抑制剂比一代BTK抑制剂Ibrutinib有更好、更完全的BTK抑制率,不仅对骨髓和外周血,对淋巴结也具有更好的BTK抑制率。正因为PK/PD数据上的优势,理论上而言Zanubrutinib能够获得更好的治疗反应、毒副反应更加小。今年的EHA和ASH会议上,Zanubrutinib相关临床研究报道均显示出其具有良好的安全性,因不良反应导致的停药率非常低,同时临床医生比较关注的相关毒副反应如3级以上的腹泻、房颤、出血等发生率也比较低。

新一代BTK抑制剂大多数为2期临床研究,而Ibrutinib在国外上市时间比较长,可能已有成千甚至上万例次的患者应用。因此,关于新一代BTK抑制剂从安全和疗效上是否完全超越了一代BTK抑制剂仍需要更长时间的随访以及更多临床患者的应用进行证实。我们也期待Zanubrutinib在未来的临床研究中以及上市以后的临床真实数据也能如当前数据一样显示出其高效、低毒性。

Zanubrutinib的问世是我国自主研发药的重大里程碑,应用前景非常广阔

Zanubrutinib在MCL中取得了非常好的疗效。我们中心参与的在中国开展的独立、关键性、开放、单臂研究包括一些其他病种如CLL/SLL,华氏巨球蛋白血症(WM)、弥漫大B细胞淋巴瘤(DLBCL)等;特别在R/R的CLL/SLL和WM中,Zanubrutinib同样显示出高效、低毒性的特点。目前,Zanubrutinib在全球范围内的临床研究还包括滤泡淋巴瘤(FL)等,以及与一代BTK抑制剂Ibrutinib的头对头3期临床研究(包括WM等适应证);这些研究都值得关注和称赞。另外,随着更多临床研究数据的公布,我们期待新一代BTK抑制剂Zanubrutinib能在更多的病种中表现出良好的结果,进而提高更多淋巴瘤亚型的疗效。

今年,百济神州已向中国药品监督管理局递交了Zanubrutinib在复发/难治MCL以及CLL/SLL适应证的新药上市申请,预期不久后能在中国上市。如果上市之后的价格更加亲民,则更能符合百济神州始终倡导的“让中国老百姓用得起新药和好药”的理念,这也是临床医生和患者共同期待的。同时,Zanubrutinib的即将上市对我国生物制药来说意义非凡。以前新药研究以仿制为主,Zanubrutinib这类新药的研发与上市标志着我国对新药的研制已经摆脱过去的仿制模式,不仅能为淋巴瘤的治疗带来非常好的前景,更是代表着我国制药企业也能引领创新,具有里程碑意义。

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    2019-03-31 xzw113
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    2018-12-31 lqvr
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2018年12月1-4日,美国血液学年会(ASH)即将在美国·圣地亚哥召开。北京大学肿瘤医院宋玉琴教授将以口头报告的形式公布百济神州研发的新一代BTK抑制剂Zanubrutinib治疗复发/难治套细胞淋巴瘤的疗效及安全性II期临床试验研究结果。

Zanubrutinib治疗MCL全球多中心临床试验AU-003结果显示良好的有效性和安全性

近年来,随着对套细胞淋巴瘤(MCL)的病理及发病机制的深入认识,以BTK抑制剂为代表的靶向药物在治疗MCL表现出卓越的疗效,其中Zanubrutinib是由百济神州自主研发的全球新一代BTK小分子抑制剂,在已进行的临床试验阶段表现出良好的有效性和安全性。在即将召开的2018 ASH大会上,来自澳大利亚的Constantine S. Tam教授将报道Zanubrutinib治疗MCL的最新研究结果。

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