Reported Wednesday, HUTCHMED And AstraZeneca's ORPATHYS-TAGRISSO Therapy Advances In China With Priority NDA Status For MET-Amplified Lung Cancer
Reported Wednesday, HUTCHMED And AstraZeneca's ORPATHYS-TAGRISSO Therapy Advances In China With Priority NDA Status For MET-Amplified Lung Cancer
This acceptance also triggers a milestone payment from AstraZeneca.
该接受也触发了阿斯利康的一个里程碑付款。
The NDA is supported by data from SACHI, a multi-center, open-label, randomized, controlled, Phase III trial which evaluated the efficacy and safety of a combination of ORPATHYS and TAGRISSO compared to platinum-based doublet-chemotherapy (pemetrexed plus cisplatin or carboplatin), the standard-of-care treatment option in this setting. The primary endpoint of the study was progression free survival ("PFS") as assessed by investigators. Other endpoints include PFS assessed by an independent review committee, overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety. The Independent Data Monitoring Committee ("IDMC") of SACHI has considered that the study has met the pre-defined primary endpoint of PFS in a planned interim analysis and as a result, enrollment into the study has concluded. Results from SACHI will be submitted for presentation at an upcoming scientific conference (clinicaltrials.gov identifier NCT05015608).
该新药申请得到了来自SACHI的数据支持，这是一项多中心、开放标签、随机、对照的III期试验，评估了ORPATHYS和TAGRISSO与基于铂金的双药化疗（培美曲塞加顺铂或卡铂）相比的疗效和安全性，后者是该领域的标准治疗选项。研究的主要终点是由研究者评估的无进展生存期（"PFS"）。其他终点包括独立评审委员会评估的PFS、总体生存期（OS）、客观缓解率（ORR）、反应持续时间（DoR）、疾病控制率（DCR）、反应时间（TTR）和安全性。SACHI的独立数据监测委员会（"IDMC"）认为，该研究在计划的中期分析中已经达到了预先定义的主要终点PFS，因此，该研究的入组已结束。SACHI的结果将被提交到即将召开的科学会议上进行展示（clinicaltrials.gov标识符NCT05015608）。
