科伦博泰生物-B新药抗PD-L1塔戈利单抗获批上市
财中社1月20日电科伦博泰生物-B（06990）发布公告，公司的抗PD-L1单抗塔戈利单抗（前称KL-A167）已获得中国国家药品监督管理局批准上市。该药物用于一线治疗复发或转移性鼻咽癌患者，联合顺铂和吉西他滨的治疗方案在有效性和安全性方面表现优异。
临床研究显示，塔戈利单抗联合化疗组的无进展生存期（PFS）优于安慰剂组，具体中位PFS未达到，而安慰剂组为7.9个月，疾病进展或死亡风险降低53%。此外，客观缓解率（ORR）为81.7%对比74.5%，中位缓解持续时间（DoR）为11.7个月对比5.8个月，显示出显著优势。尽管总生存期（OS）数据尚未成熟，但已有观察到获益趋势，死亡风险降低38%。
这是塔戈利单抗获得的第二项适应症，之前已获批用于治疗经历过2线及以上化疗失败的复发或转移性鼻咽癌患者。公司提醒股东及潜在投资者在买卖公司证券时需审慎行事。
（文章来源：财中社）
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