AstraZeneca's Combination Cancer Drug For Advanced Breast Cancer Study Flunks Late-Stage Trial
AstraZeneca's Combination Cancer Drug For Advanced Breast Cancer Study Flunks Late-Stage Trial
Tuesday, AstraZeneca Plc (NASDAQ:AZN) announced topline data from the CAPItello-290 Phase 3 trial for Truqap (capivasertib) in combination with paclitaxel in patients with locally advanced (inoperable) or metastatic triple-negative breast cancer (TNBC).
週二，阿斯利康公司（納斯達克：AZN）宣佈了CAPItello-290第三階段試驗的頂線數據，針對在局部晚期（無法手術）或轉移的三陰性乳腺癌（TNBC）患者使用Truqap（capivasertib）聯合紫杉醇的試驗。Truqap目前正在與已有的治療方案聯合使用的第三階段試驗中評估，包括針對乳腺癌（CAPItello-292）和前列腺癌（CAPItello-280和CAPItello-281）的試驗。（capivasertib）與紫杉醇聯合用於局部晚期（無法手術）或轉移的三陰性乳腺癌（TNBC）患者。
The study did not meet the dual primary endpoints of improvement in overall survival (OS) versus paclitaxel in combination with placebo in either the overall trial population or in a subgroup of patients with tumors harboring specific biomarker alterations (PIK3CA, AKT1, or PTEN).
該研究未能滿足對整個試驗人群或對攜帶特定生物標誌改變的腫瘤患者亞組（PIK3CA、AKT1或PTEN）中與紫杉醇聯合安慰劑相比改善總生存率（OS）的雙重主要終點。
Also Read: AstraZeneca Says Calquence/Chemo Combo Data Shows Additional 16.8 Months Without Disease Progression In Patients With Certain Type Of Blood Cancer.
還閱讀：阿斯利康表示，Calquence/化療組合數據顯示在患有某種類型血液癌症的患者中，額外16.8個月沒有疾病進展。
TNBC is defined as negative for all three. In the 1st-line setting, approximately 59,000 patients with TNBC are treated with a medicine.
TNBC被定義爲三種都爲陰性。在一線設置中，約有59,000名TNBC患者使用藥物治療。
Collectively, mutations in PIK3CA, AKT1, and alterations in PTEN affect approximately 35% of patients with TNBC.
綜合來看，PIK3CA、AKT1的突變和PTEN的改變影響了約35%的TNBC患者。
"While we are disappointed in the CAPItello-290 outcome, these results will further our understanding of the role of the PI3K/AKT pathway in breast cancer as we continue our clinical research across the Truqap clinical development program and across our pipeline," said Susan Galbraith, executive vice president, oncology R&D, AstraZeneca.
“雖然我們對CAPItello-290的結果感到失望，但這些結果將進一步促進我們對於PI3K/AKT通路在乳腺癌中的作用的理解，同時我們將在整個Truqap臨床開發計劃和我們的項目中繼續開展臨床研究，” 阿斯利康腫瘤研發執行副總裁蘇珊·加爾佈雷斯說。Truqap聯合紫杉醇在CAPItello臨床開發計劃和我們的項目繼續開展臨床研究中。
The safety profile of Truqap in combination with paclitaxel in CAPItello-290 was broadly consistent with the known safety profile of each medicine with no new safety concerns identified.
Tagrisso的安全性能夠得到控制並且一般與每個藥物的規定安全係數一致。Tagrisso加化療的不良事件（AE）發生率比Tagrisso單藥治療組更高，這是由化療相關AE驅動的，這些AE已經被充分說明。因AE而終止Tagrisso的停藥率爲11％。Truqap與紫杉醇聯合用於CAPItello-290試驗的表現與每種藥物已知的安全性情況大致一致，沒有發現新的安全問題。
Truqap is currently being evaluated in Phase 3 trials for breast cancer (CAPItello-292) and prostate cancer (CAPItello-280 and CAPItello-281) in combination with established treatments.
Truqap目前正在與已有的治療方案聯合使用的第三階段試驗中評估，包括針對乳腺癌（CAPItello-292）和前列腺癌（CAPItello-280和CAPItello-281）的試驗。目前正在進行第3階段臨床試驗，用於治療乳腺癌（CAPItello-292）和前列腺癌（CAPItello-280和CAPItello-281），結合已有治療方法。
Last month, AstraZeneca said the survival results did not reach statistical significance in the overall trial population in the TROPION-Lung01 phase 3 trial.
上個月，阿斯利康表示，在TROPION-Lung01第三階段試驗的整體試驗人群中，生存結果沒有達到統計學意義。
Price Action: AZN shares are down 0.49% at $78.92 during the premarket session at last check Tuesday.
股票代碼AZN的股價在週二盤前交易時下跌0.49%，至78.92美元。
Image by Lydia Ilyakhina via Shutterstock
圖片由shutterstock的Lydia Ilyakhina提供
譯文內容由第三人軟體翻譯。