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阿斯利康与第一三共合作开发的TROP2 ADC药物DS-1062(datopotamab deruxtecan)在临床试验中总生存期(OS)数据未达到统计学假设但数值上有利于该药物。尽管未达到OS主要终点TROPION-Lung01临床研究已在无进展生存期(PFS)上达到主要研究终点支持了上市申请。目前该药物的上市申请正在接受美国和欧盟等全球监管机构的评审。业内人士认为尽管OS是药物审评的“金标准”但PFS的积极结果可能对审评产生积极影响。(每经)

The overall survival (OS) data for the TROP2 ADC drug DS-1062 (datopotamab deruxtecan), developed by AstraZeneca in collaboration with Daiichi Sankyo, did not meet statistical assumptions but was numerically beneficial to the drug in clinical trials. Alth

Zhitong Finance ·  May 29 20:53
The overall survival (OS) data for the TROP2 ADC drug DS-1062 (datopotamab deruxtecan), developed by AstraZeneca in collaboration with Daiichi Sankyo, did not meet statistical assumptions but was numerically beneficial to the drug in clinical trials. Although the Tropion-Lung01 clinical study did not reach the primary OS endpoint, the application for marketing was supported by reaching the primary study endpoint in progression-free survival (PFS). Currently, the drug's marketing application is being reviewed by global regulators such as the US and the European Union. Industry insiders believe that although OS is the “gold standard” for drug review, the positive results of PFS may have a positive impact on the review. (every time)

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