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（纳斯达克股票代码：AZN）报告了一项转移性乳腺癌治疗研究的头条数据。
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.
结果显示，在接受一条或多条内分泌治疗的HR阳性、HER2-低（IHC 1+或2+/ISH-）转移性乳腺癌患者的初级试验人群中，与标准护理化疗相比，Enhertu（曲妥珠单抗德鲁克替康）的无进展存活率（PFS）在统计学上显著且具有临床意义的改善。
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).
在整个试验人群（HER2-Low和HER2-UltraLow（定义为具有膜染色的IHC 0；IHC >0
Related: AstraZeneca Posts Bumper Earnings On Strong Sales From Cancer Drugs, Sticks To Annual Guidance.
相关信息：阿斯利康公布了抗癌药物销售强劲的丰厚收益，与年度预期持平。
A prespecified subgroup analysis showed that clinically meaningful improvement was consistent between patients with HER2-low and HER2-ultralow expression.
预先指定的亚组分析显示，HER2-低表达和HER2-超低表达患者临床上有意义的改善是一致的。
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.
在分析时，总存活率（OS）数据尚未成熟。但是，Enhertu显示出操作系统改进的早期趋势。将其与HER2低转移性乳腺癌患者和总试验人群的标准护理化疗进行了比较。
The trial will continue to assess OS and other secondary endpoints further.
该试验将继续进一步评估操作系统和其他辅助终端。
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（场外交易代码：DSKYF）（场外交易代码：DSNKY）发现的一种指向HER2的DxD抗体药物偶联物，由阿斯利康和第一三共共同开发和商业化。
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.
同时，欧盟已建议阿斯利康的Truqap（capivasertib）与Faslodex（氟维司朗）联合用于雌激素受体（ER）阳性、HER2阴性的局部晚期或转移性乳腺癌的成年患者，在内分泌疗法复发或进展后出现一种或多种 PIK3CA、AKT1 或 PTEN改变。
The Committee for Medicinal Products for Human Use of the European Medicines Agency based its opinion on the CAPItello-291 Phase 3 trial results.
欧洲药品管理局人用药品委员会根据Capitello-291三期试验结果发表意见。
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与Faslodex联合使用可将疾病进展或死亡的风险降低50％。相比之下，在患有PI3K、AKT或PTEN变异的肿瘤患者中单独使用Faslodex（基于0.50，p=
Price Action: AZN shares are up 1.65% at $76.41 during the premarket session at the last check Monday.
价格走势：周一最后一次盘前交易中，AZN股价上涨1.65％，至76.41美元。