基石药业(02616.HK):GEMSTONE-302研究达到统计学显着性
基石药业-B(02616.HK)公布,在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,显着延长了研究者评估的无进展生存期(「PFS」)。结果达到统计学显着性,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。
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