Latest Trial Setback For AstraZeneca's Dato-DXd, The Drug Fails To Extend Lives Of Pretreated Breast Cancer Patients
Latest Trial Setback For AstraZeneca's Dato-DXd, The Drug Fails To Extend Lives Of Pretreated Breast Cancer Patients
Monday, AstraZeneca Plc (NASDAQ:AZN) released high-level results from the TROPION-Breast01 Phase 3 trial of datopotamab deruxtecan (Dato-DXd) compared to the investigator's choice of chemotherapy.
周一，阿斯利康公司（纳斯达克:AZN）发布了datopotamab deruxtecan（Dato-DXd）与调查者选择的化疗方案相比的TROPION-Breast01第3期试验的高级结果。
The study did not achieve statistical significance in the final overall survival (OS) analysis in patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.
该研究在患有不可手术或转移性激素受体（HR）阳性、HER2低或阴性的乳腺癌患者以前接受内分泌为基础治疗和至少一种系统疗法的最终总体生存（OS）分析中未达到统计学意义。
The study previously met the dual primary endpoint of progression-free survival.
该研究先前已达到无进展生存的双重主要终点。
Also Read: AstraZeneca CEO Pascal Soriot Updates On Chinese Compliance Probe And Lung Cancer Drug Trial Results.
阿斯利康首席执行官Pascal Soriot就中国合规调查和肺癌药物试验结果进行了更新。
An improvement in patient-reported outcomes was also seen.
患者报告结果的改善也得到认可。
The safety profile of datopotamab deruxtecan was consistent with that observed in the previous analysis, including lower rates of Grade 3 or higher treatment-related adverse events compared to chemotherapy, and no new safety concerns were identified.
datopotamab deruxtecan的安全性概况与之前分析中观察到的一致，包括较低比例的3级或更高级别与化疗相关的不良事件，且未发现新的安全问题。
All-grade interstitial lung disease (ILD) rates remained low, and no new Grade 3 or higher ILD events were observed.
所有级别的间质性肺疾病（ILD）发病率仍然较低，且未观察到新的3级或更高级别的ILD事件。
With multiple antibody-drug conjugates (ADCs) approved during the trial, including Enhertu (trastuzumab deruxtecan), subsequent treatment following patients' disease progression or treatment discontinuation is likely to have affected survival results.
在试验期间获批的多种抗体药物结合物（ADCs）包括Enhertu（曲妥珠单抗），随后治疗令患者疾病进展或治疗中断可能已影响生存结果。
Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd ADC discovered by Daiichi Sankyo Ltd (OTC:DSKYF) (OTC:DSNKY) and being jointly developed by AstraZeneca and Daiichi Sankyo.
Datopotamab deruxtecan是一种由日本第一三共制药有限公司（场外交易:DSKYF）（场外交易:DSNKY）发现，由阿斯利康和第一三共共同开发的专门设计的TROP2-导向的DXd ADC。
Earlier this month, AstraZeneca shared detailed results from the TROPION-Lung01 Phase 3 of datopotamab deruxtecan (Dato-DXd) compared to docetaxel, the current standard of care chemotherapy for locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy.
本月早些时候，阿斯利康分享了TROPION-Lung01第3期数据，比较了datopotamab deruxtecan（Dato-DXd）和紫杉醇，紫杉醇是目前治疗局部晚期或转移非角鳞状非小细胞肺癌（NSCLC）的标准化疗药物，且至少已接受一线治疗。
In the overall trial population, OS results numerically favored datopotamab deruxtecan compared to docetaxel (12.9 vs. 11.8 months) but did not reach statistical significance.
在整体试验人群中，datopotamab deruxtecan与紫杉醇相比，总生存时间结果在数据上有利于datopotamab deruxtecan（12.9个月对比11.8个月），但并未达到统计学意义。
Friday, the FDA approved AstraZeneca's FluMist as the only self-administered influenza vaccine.
周五，FDA批准了阿斯利康的FluMist，作为唯一可以自行使用的流感疫苗。
FluMist, a needle-free nasal spray, was approved for self-administration by adults up to 49 years of age or for parent/caregiver administration to individuals 2-17 years of age.
FluMist是一种无针喷剂，获准供成年人自行使用，年龄可达49岁，或供父母/照料者给2-17岁的人使用。
Once available, individuals 18 and older can have FluMist delivered directly to their homes via FluMist Home.
一旦可用，18岁及以上的人可以通过FluMist Home直接将FluMist送到家中。
Price Action: AZN stock is down 1.86% at $76.92 during the premarket session at last check Monday.
股价走势：在上周一的盘前交易中，AZN股价下跌1.86%，最新报价为76.92美元。
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Image by Robert Way via Shutterstock
图像来自Shutterstock的Robert Way
