Double Good News For AstraZeneca's Breast Cancer Drugs
Double Good News For AstraZeneca's Breast Cancer Drugs
AstraZeneca plc (NASDAQ:AZN) reported topline data from a metastatic breast cancer treatment study.
阿斯利康公司（納斯達克股票代碼：AZN）報告了一項轉移性乳腺癌治療研究的頭條數據。
The results showed that Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy in the primary trial population of patients with HR-positive, HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer following one or more lines of endocrine therapy.
結果顯示，在接受一條或多條內分泌治療的HR陽性、HER2-低（IHC 1+或2+/ISH-）轉移性乳腺癌患者的初級試驗人群中，與標準護理化療相比，Enhertu（曲妥珠單抗德魯克替康）的無進展存活率（PFS）在統計學上顯著且具有臨床意義的改善。
A statistically significant and clinically meaningful improvement in PFS was also observed in the overall trial population (patients with HER2-low and HER2-ultralow [defined as IHC 0 with membrane staining; IHC >0<1+] metastatic breast cancer).
在整個試驗人群（HER2-Low和HER2-UltraLow（定義爲具有膜染色的IHC 0；IHC >0
Related: AstraZeneca Posts Bumper Earnings On Strong Sales From Cancer Drugs, Sticks To Annual Guidance.
相關信息：阿斯利康公佈了抗癌藥物銷售強勁的豐厚收益，與年度預期持平。
A prespecified subgroup analysis showed that clinically meaningful improvement was consistent between patients with HER2-low and HER2-ultralow expression.
預先指定的亞組分析顯示，HER2-低表達和HER2-超低表達患者臨床上有意義的改善是一致的。
Overall survival (OS) data were not mature at the time of the analysis. However, Enhertu showed an early trend towards an OS improvement. It was compared to standard-of-care chemotherapy in patients with HER2-low metastatic breast cancer and the overall trial population.
在分析時，總存活率（OS）數據尚未成熟。但是，Enhertu顯示出操作系統改進的早期趨勢。將其與HER2低轉移性乳腺癌患者和總試驗人群的標準護理化療進行了比較。
The trial will continue to assess OS and other secondary endpoints further.
該試驗將繼續進一步評估操作系統和其他輔助終端。
Enhertu is a HER2-directed DXd antibody-drug conjugate discovered by Daiichi Sankyo (OTC:DSKYF) (OTC:DSNKY) and is being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.
Enhertu是由第一三共公司（場外交易代碼：DSKYF）（場外交易代碼：DSNKY）發現的一種指向HER2的DxD抗體藥物偶聯物，由阿斯利康和第一三共共同開發和商業化。
Concurrently, AstraZeneca's Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been recommended for approval in the European Union for adult patients with estrogen receptor (ER)-positive, HER2‐negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen.
同時，歐盟已建議阿斯利康的Truqap（capivasertib）與Faslodex（氟維司朗）聯合用於雌激素受體（ER）陽性、HER2陰性的局部晚期或轉移性乳腺癌的成年患者，在內分泌療法復發或進展後出現一種或多種 PIK3CA、AKT1 或 PTEN改變。
The Committee for Medicinal Products for Human Use of the European Medicines Agency based its opinion on the CAPItello-291 Phase 3 trial results.
歐洲藥品管理局人用藥品委員會根據Capitello-291三期試驗結果發表意見。
Truqap in combination with Faslodex reduced the risk of disease progression or death by 50%. Compare that to Faslodex alone in patients with tumors harboring PI3K, AKT, or PTEN alterations (based on a hazard ratio of 0.50, p=<0.001; median PFS 7.3 versus 3.1 months).
Truqap與Faslodex聯合使用可將疾病進展或死亡的風險降低50％。相比之下，在患有PI3K、AKT或PTEN變異的腫瘤患者中單獨使用Faslodex（基於0.50，p=
Price Action: AZN shares are up 1.65% at $76.41 during the premarket session at the last check Monday.
價格走勢：週一最後一次盤前交易中，AZN股價上漲1.65％，至76.41美元。
譯文內容由第三人軟體翻譯。