百济神州(06160.HK)在AACR 2021年会公布百泽安®治疗二线或三线非小细胞肺癌RATIONALE 303临试中期分析结果
格隆汇 4 月 13日丨百济神州(06160.HK)于2021年4月12日(美国东部时间)在美国癌症研究协会(AACR)2021年年会上的一项口头报告中公布了其抗PD-1抗体百泽安® (替雷利珠单抗)对比多西他赛针对二线或三线局部晚期或转移性非小细胞肺癌(NSCLC)患者的全球3期临床试验的中期分析结果。基于此项试验结果的新适应症上市申请(sBLA)已于2021年3月在中国获受理,目前正在接受审评。
百济神州肿瘤免疫学首席医学官贲勇医学博士表示:“今天公布的结果证明,百泽安®有望为二线或三线局部晚期或转移性NSCLC患者带来生存益处,这与我们在去年的ASCO以及ESMO年会上公布针对初治患者的两项试验结果相一致。此外,百泽安®总体耐受,与先前在其他多项肿瘤中公布的结果和已知风险相符。 RATIONALE 303的试验结果鼓舞人心,不仅支持了百泽安®在中国已获受理针对二或三线NSCLC的新适应症上市申请,也进一步表明百泽安®是一款潜在差异化检查点抑制剂。”
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