基石药业-B(02616.HK)：舒格利单抗可为晚期非小细胞肺癌患者提供新的治疗选择
格隆汇 11 月 23日丨基石药业-B(02616.HK)发布公告，2020年欧洲肿瘤内科学会亚洲年会线上年会上以口头报告形式首次公布了GEMSTONE-302研究详细结果。结果显示舒格利单抗联合化疗较安慰剂联合化疗，作为晚期非小细胞肺癌(“NSCLC”)一线治疗，显著延长了研究者评估的无进展生存期(“PFS”)。结果达到统计学显著性，且有临床意义。舒格利单抗联合化疗的安全性良好，未发现新的安全性信号。
GEMSTONE-302是全球首个抗PD-L1单抗联合化疗作为一线治疗在IV期鳞状和非鳞状NSCLC患者中的随机双盲III期临床试验。该研究旨在评估舒格利单抗联合化疗对比安慰剂联合化疗，在未经一线治疗的、IV期NSCLC患者中的有效性和安全性。该研究主要终点为研究者评估的PFS；次要终点包括总生存期，盲态独立中心审阅委员会(“BICR”)评估的PFS和安全性等。
截至2020年6月8日，研究共入组479例患者，期中分析资料显示，舒格利单抗联合化疗对比安慰剂联合化疗，显著延长患者的PFS，达到了研究的主要终点。
GEMSTONE-302研究主要研究者，上海市肺科医院肿瘤科主任周彩存教授表示：“GEMSTONE-302研究创新性的在一个临床研究中同时纳入肺鳞癌患者和肺腺癌患者，采用免疫联合化疗对比安慰剂联合化疗的研究设计，在一个临床研究中同时评估两种肿瘤组织亚型患者的疗效，并最终达到了研究的主要终点，且在肺鳞癌患者和肺腺癌患者中均观察到了临床获益。肺癌的发病率和致死率在全球均居于首位，相信凭藉本研究的优异资料，舒格利单抗可以为晚期NSCLC患者提供新的治疗选择，并以其低安全风险，高反应率，持久的疗效惠及更多的患者。”
基石药业首席医学官杨建新博士表示：“GEMSTONE-302研究结果令人鼓舞，舒格利单抗联合化疗降低疾病进展或死亡风险50%，客观缓解率高达61.4%，且安全耐受。这些优异的结果提示舒格利单抗相比已报过结果的PD-1/PD-L1单抗，具有同类最佳的潜力。目前中国国家药品监督管理局已正式受理舒格利单抗新药上市申请。我们期待舒格利单抗能够早日获批，惠及更多患者。”
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