基石药业(02616.HK)：avapritinib可使PDGFRA D842V突变型GIST患者达到持久临床获益，研究发表于“柳叶刀肿瘤学”
格隆汇7月6日丨基石药业－Ｂ(02616.HK)发布公告，公司的合作伙伴 Blueprint Medicines Corporation (Blueprint Medicines，纳斯达克股份代号：BPMC)于6月29日宣布，“柳叶刀肿瘤学”发表了 NAVIGATOR 临床试验结果，资料显示 avapritinib 用于 PDGFRA D842V 突变型晚期胃肠间质瘤(“GIST”)患者，24个月的总生存(「OS」)率达到 81%，且耐受性良好。该研究报告2020年6月29日正式发表于“柳叶刀肿瘤学”，文章标题为“avapritinib 治疗晚期 PDGFRA D842V 突变型胃肠间质瘤(NAVIGATOR)：一项多中心、开放标签的一期研究”。
Blueprint Medicines 已与基石药业达成独家合作及授权授权合约，在中国内地和香港特别行政区、澳门特别行政区及中国台湾推进 avapritinib、fisogatinib 和 pralsetinib 的研发和商业化。 Blueprint Medicines 将保留以上相关产品在全球其他国家/地区的研发和商业化权利。
有关重点消息包括：发表于“柳叶刀肿瘤学”上的文章报告了 NAVIGATOR 试验的有效性和安全性结果，包括剂量递增阶段的所有患者，以及扩展阶段的 PDGFRA D842V 突变型 GIST 亚组患者。疗效分析人群包括56例 PDGFRA D842V 突变型 GIST 患者。安全性分析人群包括82例患者，其中包括剂量递增研究阶段的26例非 PDGFRA D842V 突变型 GIST 患者。所有资料截止日期为2018年11月16日；
资料显示，接受 avapritinib 治疗的 PDGFRA D842V 突变型 GIST 患者中，总体缓解率达到 88%(95% CI：76%-95%)，有 9%的患者达到完全缓解。avapritinib 治疗在这一患者人群中显示出了持久的临床获益，12个月持续缓解率为 70%(95% CI： 54%-87%)，12个月无进展生存率为 81%(95% CI：69%-93%)，24个月总生存率为 81%(95% CI：67%-94%)；
avapritinib 总体耐受性良好，研究中报告的治疗相关不良事件大部分为一级或二级。最常见的治疗相关不良事件为恶心、疲乏、腹泻、眶周水肿、贫血、食欲减退、呕吐和记忆力减退。40%的患者出现认知障碍，大多数报告的事件为一级。
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