《柳叶刀》：信达生物PD-1抑制剂治疗cHL与“O药”、“K药”不分伯仲
以下文章来源于GBIHealth ，作者GBIHealth
近日，世界顶级医学杂志《柳叶刀》发表了一项新研究，详细介绍了苏州信达生物旗下PD-1抑制剂达伯舒®（英文商标：Tyvyt®，化学通用名：信迪利单抗注射液）治疗经典霍奇金淋巴瘤（cHL）的II期临床数据。
自2017年4月19日至2017年11月1日，该名为ORIENT-1的试验在中国的18家医院共招募96例患者。 其中，96％的患者受试前接受了干细胞移植，54.2％接受了放射治疗。试验期间，患者静脉给予信迪利单抗 200mg，每3周一次，直至疾病进展、死亡、不可接受毒性或撤出研究。
中位随访10.5个月后，共有74名患者（80.4％）出现客观反应（完全或部分缓解），而34％的患者肿瘤消失。 在安全性方面， 17例（18%）发生3或4级治疗相关不良事件，最常见的不良反应是发热，研究中没有患者死亡。
期刊主编Stephen M Ansell教授撰写述评指出，与已在全球上市的两款PD-1抑制剂，即默沙东帕博利珠单抗和百时美施贵宝纳武单抗(nivolumab)研究数据相比，ORIENT-1研究充分表明，患者均从信迪利单抗治疗中获益，“该研究显示，接受信迪利单抗治疗患者出现的反应率与获益持久性与其它PD-1抗体治疗非常类似。” 据Lymphoma News Today报道，77.6%的cHL患者使用信迪利单抗治疗6个月后，没有出现疾病进展迹象；而在纳武单抗和帕博利珠单抗治疗cHL患者中的II期临床试验中，分别有77％和69％的患者没有出现疾病进展。
信达生物和礼来在2015年就信迪利单抗达成开发合作伙伴关系，并于2018年12月获得国家药品监督管理局批准上市，用于治疗至少经过二线系统化疗的复发或难治性经典型霍奇金淋巴瘤（cHL）。截至目前，除了百济神州于2018年9月就其PD-1抗体tislelizumab用于治疗cHL提交新药申请（NDA）外，国内还没有其他类似药物获得批准。
A new study published in The Lancet provides details of Phase II data for Innovent Biologics Inc. (HKEX: 01801)’s programmed death-1 (PD-1) inhibitor Tyvyt (sinitilimab) as a treatment for classic Hodgkin lymphoma (cHL).
The ORIENT-1 study enrolled 96 cHL sufferers over April to November 2017 across 18 hospitals in China. The majority (96%) of patients had undergone a stem-cell transplant, while 54.2% had received radiotherapy.
Patients were given intravenous sintilimab (200 mg, once every 3 weeks) until progression, death, unacceptable toxicity, or withdrawal of consent. After a median follow-up of 10.5 months, a total of 74 patients (80.4%) achieved an objective response, meaning complete or partial remission, while the tumor disappeared in 34% of cases. In terms of safety profile, 17 patients (18%) administered Tyvyt reported Grade 3 or 4 adverse events related to treatment, most commonly pyrexia (fever). There were no patient deaths during the study.
In an editorial comment, Lancet Haematology editor Stephen M Ansell notes that sintilimab’s performance in cHL bears favorable comparison with data achieved by the globally approved PD-1 inhibitors Keytruda (pembrolizumab; Merck & Co.) and Opdivo (nivolumab; Bristol-Myers Squibb): “Treatment with sintilimab, as reported in this trial, results in response rates very similar to those of other PD-1 antibodies as well as similar durability of benefit”. As noted by LymphomaNewsToday, 77.6% of patients treated with sintilimab showed no signs of disease progression after six months, compared with Phase II data for Opdivo and Keytruda in cHL where that same figure was 77% and 69% respectively.
Tyvyt is under co-development with Eli Lilly & Co., and was approved as a treatment for cHL in China in December 2018. There are no other PD-1 therapies approved in China for the indication at present, although BeiGene filed a first NDA for the PD-1 drug tislelizumab in cHL in September 2018.
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