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.
週一，阿斯利康公司（納斯達克:AZN）發佈了datopotamab deruxtecan（Dato-DXd）與調查者選擇的化療方案相比的TROPION-Breast01第3期試驗的高級結果。
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.
該研究在患有不可手術或轉移性激素受體（HR）陽性、HER2低或陰性的乳腺癌患者以前接受內分泌爲基礎治療和至少一種系統療法的最終總體生存（OS）分析中未達到統計學意義。
The study previously met the dual primary endpoint of progression-free survival.
該研究先前已達到無進展生存的雙重主要終點。
Also Read: AstraZeneca CEO Pascal Soriot Updates On Chinese Compliance Probe And Lung Cancer Drug Trial Results.
阿斯利康首席執行官Pascal Soriot就中國合規調查和肺癌藥物試驗結果進行了更新。
An improvement in patient-reported outcomes was also seen.
患者報告結果的改善也得到認可。
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的安全性概況與之前分析中觀察到的一致，包括較低比例的3級或更高級別與化療相關的不良事件，且未發現新的安全問題。
All-grade interstitial lung disease (ILD) rates remained low, and no new Grade 3 or higher ILD events were observed.
所有級別的間質性肺疾病（ILD）發病率仍然較低，且未觀察到新的3級或更高級別的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.
在試驗期間獲批的多種抗體藥物結合物（ADCs）包括Enhertu（曲妥珠單抗），隨後治療令患者疾病進展或治療中斷可能已影響生存結果。
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是一種由日本第一三共製藥有限公司（場外交易:DSKYF）（場外交易:DSNKY）發現，由阿斯利康和第一三共共同開發的專門設計的TROP2-導向的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.
本月早些時候，阿斯利康分享了TROPION-Lung01第3期數據，比較了datopotamab deruxtecan（Dato-DXd）和紫杉醇，紫杉醇是目前治療局部晚期或轉移非角鱗狀非小細胞肺癌（NSCLC）的標準化療藥物，且至少已接受一線治療。
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.
在整體試驗人群中，datopotamab deruxtecan與紫杉醇相比，總生存時間結果在數據上有利於datopotamab deruxtecan（12.9個月對比11.8個月），但並未達到統計學意義。
Friday, the FDA approved AstraZeneca's FluMist as the only self-administered influenza vaccine.
週五，FDA批准了阿斯利康的FluMist，作爲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是一種無針噴劑，獲准供成年人自行使用，年齡可達49歲，或供父母/照料者給2-17歲的人使用。
Once available, individuals 18 and older can have FluMist delivered directly to their homes via FluMist Home.
一旦可用，18歲及以上的人可以通過FluMist Home直接將FluMist送到家中。
Price Action: AZN stock is down 1.86% at $76.92 during the premarket session at last check Monday.
股價走勢：在上週一的盤前交易中，AZN股價下跌1.86%，最新報價爲76.92美元。
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Image by Robert Way via Shutterstock
圖像來自Shutterstock的Robert Way