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Update on the CAPItello-290 Phase III Trial for Truqap Plus Chemotherapy in Advanced or Metastatic Triple-negative Breast Cancer

Update on the CAPItello-290 Phase III Trial for Truqap Plus Chemotherapy in Advanced or Metastatic Triple-negative Breast Cancer

愛文思控股更新CAPItello-290第三期試驗，測試Truqap與化療聯合用於晚期或轉移性三陰性乳腺癌。
阿斯利康 ·  06/18 12:00

The CAPItello-290 Phase III trial for Truqap (capivasertib) in combination with paclitaxel in patients with locally advanced (inoperable) or metastatic triple-negative breast cancer (TNBC) 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 tumours harbouring specific biomarker alterations (PIK3CA, AKT1 or PTEN).

Capitello-290 三期試驗 Truqap (capivasertib) 與紫杉醇聯合治療局部晚期（無法手術）或轉移性三陰性乳腺癌（TNBC）患者在總試驗人群或具有特定生物標誌物變異的腫瘤亞組（PIK3CA、AKT1 或 PTEN）中均未達到與紫杉醇聯合安慰劑相比總體存活率（OS）改善的兩個主要終點）。

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of human epidermal growth factor receptor 2 (HER2), TNBC is defined as negative for all three.2 In the 1st-line setting, approximately 59,000 patients with TNBC are treated with a medicine.3 Collectively, mutations in PIK3CA, AKT1 and alterations in PTEN affect approximately 35% of patients with TNBC.4

乳腺癌是第二常見的癌症，也是全球癌症相關死亡的主要原因之一。1 雖然某些乳腺癌的雌激素受體、孕酮受體或人類表皮生長因子受體2（HER2）的過度表達可能呈陽性，但三種乳腺癌的TNBC都被定義爲陰性。2 在一線環境中，大約有59,000名TNBC患者接受藥物治療。3 總的來說，PIK3CA、AKT1 的突變和 PTEN 的改變影響了大約 35% 的 TNBC 患者。4

Peter Schmid, MD, Barts Cancer Institute, London, UK, and principal investigator for the trial said: "Despite modest advances, triple-negative breast cancer remains one of the most challenging forms of disease to treat due to the lack of known actionable biomarker targets, and chemotherapy-based regimens continue to be the mainstay of treatment. While the CAPItello-290 trial results have not shown what we hoped, they provide important information to further understand this aggressive form of breast cancer where patients are in urgent need of new treatments."

英國倫敦巴茨癌症研究所醫學博士、該試驗的首席研究員彼得·施密德說：“儘管進展不大，但由於缺乏已知的可操作生物標誌物靶標，三陰性乳腺癌仍然是最具挑戰性的治療形式之一，基於化療的方案仍然是治療的支柱。儘管Capitello-290的試驗結果並未顯示出我們的期望，但它們爲進一步了解這種侵襲性乳腺癌提供了重要信息，在這種形式中，患者迫切需要新的治療方法。”

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "We are committed to advancing science for patients in some of the most challenging cancers, including this heterogeneous subtype of breast cancer. 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 programme and across our pipeline."

阿斯利康腫瘤學研發執行副總裁蘇珊·加爾佈雷思說：“我們致力於爲包括這種異質乳腺癌亞型在內的一些最具挑戰性的癌症患者推進科學發展。儘管我們對Capitello-290的結果感到失望，但隨着我們繼續在乳腺癌中進行臨床研究，這些結果將進一步加深我們對PI3K/AKT途徑在乳腺癌中的作用的理解 Truqap 臨床開發計劃以及我們的產品線。”

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. Data will be shared in due course.

的安全概況 Truqap 在Capitello-290中與紫杉醇聯合使用與每種藥物的已知安全性概況大致一致，沒有發現新的安全問題。數據將在適當時候共享。

Truqap is currently being evaluated in Phase III trials for the treatment of breast cancer (CAPItello-292) and prostate cancer (CAPItello-280 and CAPItello-281) in combination with established treatments.

Truqap 目前正在結合既定療法治療乳腺癌（Capitello-292）和前列腺癌（Capitello-280和Capitello-281）的三期試驗中進行評估。

Notes

注意事項

Triple-negative breast cancer
1st-line treatment for advanced or metastatic TNBC usually consists of chemotherapy alone or in combination with an immunotherapy – options generally associated with response rates between 30 to 50%.2,5,6 Among patients with tumours that do respond to initial treatment, disease progression is common and rapid, often occurring within two years.2,6-8 The average overall survival of patients living with advanced or metastatic TNBC is 12 to 18 months, with only about 14% of patients living five years following diagnosis.9,10

三陰性乳腺癌
晚期或轉移性TNBC的一線治療通常包括單獨化療或與免疫療法聯合使用——這些選擇通常與30％至50％的反應率有關。2,5,6 在對初始治療有反應的腫瘤患者中，疾病進展既常見又迅速，通常在兩年內發生。2,6-8 晚期或轉移性TNBC患者的平均總存活率爲12至18個月，只有大約14％的患者在診斷後活了五年。9,10

CAPItello-290
CAPItello-290 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of Truqap in combination with paclitaxel versus placebo in combination with paclitaxel in the 1st-line treatment of patients with locally advanced (inoperable) or metastatic TNBC.

Capitello-290
Capitello-290 是一項三期雙盲隨機試驗，旨在評估其療效和安全性 Truqap 在局部晚期（無法手術）或轉移性TNBC患者的一線治療中，與紫杉醇聯合對比安慰劑與紫杉醇聯合使用。

The global trial enrolled 923 adult patients with histologically confirmed locally advanced or metastatic TNBC. The trial has dual primary endpoints of OS in the overall patient population and in a population of patients whose tumours have qualifying alterations in the PI3K/AKT pathway (PIK3CA, AKT1 or PTEN genes).

該全球試驗招收了923名組織學確診的局部晚期或轉移性TNBC的成年患者。該試驗在整個患者群體和腫瘤在PI3K/AKT途徑（PIK3CA、AKT1或PTEN基因）出現合格變化的患者群體中均有操作系統的雙主要終點。

Truqap
Truqap is a first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3). Truqap 400mg is administered twice daily according to an intermittent dosing schedule of four days on and three days off. This was chosen in early phase trials based on tolerability and the degree of target inhibition.

Truqap
Truqap 是所有三種 AKT 亞型 (AKT1/2/3) 的同類首創強效三磷酸腺苷 (ATP) 競爭性抑制劑。 Truqap 400mg 根據間歇性給藥時間表每天給藥兩次，即開啓四天，休息三天。這是在早期試驗中根據耐受性和靶向抑制程度選擇的。

Truqap is approved in the US, Japan and several other countries for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN) following recurrence or progression on or after an endocrine-based regimen based on the results from the CAPItello-291 trial. Truqap is also approved in Australia for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine based regimen based on these trial results.

Truqap 根據Capitello-291試驗的結果，在美國、日本和其他幾個國家獲准用於治療HR陽性、HER2陰性的局部晚期或轉移性乳腺癌的成年患者，這些患者在內分泌療法的復發或進展後出現一種或多種生物標誌物改變（PIK3CA、AKT1或PTEN）。 Truqap 根據這些試驗結果，澳大利亞還批准用於治療在內分泌治療方案或之後復發或進展的HR陽性、HER2陰性的局部晚期或轉移性乳腺癌的成年患者。

Truqap is currently being evaluated in Phase III trials for the treatment of breast cancer (CAPItello-292) and prostate cancer (CAPItello-280 and CAPItello-281) in combination with established treatments.

Truqap 目前正在結合既定療法治療乳腺癌（Capitello-292）和前列腺癌（Capitello-280和Capitello-281）的三期試驗中進行評估。

Truqap was discovered by AstraZeneca subsequent to a collaboration with Astex Therapeutics (and its collaboration with the Institute of Cancer Research and Cancer Research Technology Limited).

Truqap 是阿斯利康在與Astex Therapeutics合作（及其與癌症研究與癌症研究技術有限公司的合作）之後被阿斯利康發現的。

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

阿斯利康治療乳腺癌
在對乳腺癌生物學越來越了解的推動下，阿斯利康開始挑戰並重新定義當前乳腺癌分類和治療的臨床模式，以便爲有需要的患者提供更有效的治療——大膽的目標是有朝一日將乳腺癌作爲死亡原因消除。

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment.

阿斯利康正在開發一系列經過批准和有前景的化合物，這些化合物利用不同的作用機制來應對生物多樣性的乳腺癌腫瘤環境。

With Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive and HER2-low metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings.

和 Enhertu （曲妥珠單抗deruxtecan），一種針對HER2的抗體藥物偶聯物（ADC），阿斯利康和第一三共的目標是改善先前治療過的HER2陽性和HER2低轉移性乳腺癌的預後，並正在探索其在早期治療和新的乳腺癌環境中的潛力。

In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap, and next-generation SERD and potential new medicine camizestrant. AstraZeneca is also collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan, in this setting.

在 HR 陽性乳腺癌中，阿斯利康繼續使用基礎藥物改善預後 Faslodex 和 Zoladex （goserelin），旨在使用同類首創的AKT抑制劑重塑HR陽性空間， Truqap，以及下一代 SERD 和潛在的新藥 camizestrant。阿斯利康還與第一三共合作，探索以TROP2爲導向的ADC，即datopotamab deruxtecan在這種環境下的潛力。

PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings and to explore its potential in earlier disease.

PARP 抑制劑 Lynparza （奧拉帕尼）是一種靶向治療方案，已在具有遺傳性BRCA突變的早期和轉移性乳腺癌患者中進行了研究。阿斯利康與默沙東（位於美國和加拿大的默沙東公司）繼續研究 Lynparza 在這些環境中並探索其在早期疾病中的潛力。

To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is evaluating the potential of datopotamab deruxtecan alone and in combination with immunotherapy Imfinzi (durvalumab), and Imfinzi in combination with other oncology medicines, including Lynparza and Enhertu.

爲了給三陰性乳腺癌（一種侵襲性乳腺癌）患者提供急需的治療選擇，阿斯利康正在評估單獨使用達託泊單抗德魯斯特康以及與免疫療法聯合使用的潛力 Imfinzi （durvalumab），以及 Imfinzi 與其他腫瘤藥物聯合使用，包括 Lynparza 和 Enhertu.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

腫瘤學領域的阿斯利康
阿斯利康正在引領一場腫瘤學革命，其目標是爲各種形式的癌症提供治療方法，遵循科學來了解癌症及其所有複雜性，發現、開發並向患者提供改變生活的藥物。

The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

該公司的重點是一些最具挑戰性的癌症。正是通過持續創新，阿斯利康建立了業內最多樣化的產品組合和管道之一，有可能催化醫學實踐的變革並改變患者體驗。

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

阿斯利康的願景是重新定義癌症治療，並有朝一日消除癌症的死因。

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca.

阿斯利康
阿斯利康（倫敦證券交易所/STO/納斯達克股票代碼：AZN）是一家以科學爲主導的全球生物製藥公司，專注於腫瘤學、罕見疾病和生物製藥（包括心血管、腎臟與代謝以及呼吸與免疫學）中處方藥的發現、開發和商業化。阿斯利康總部位於英國劍橋，業務遍及100多個國家，其創新藥物被全球數百萬患者使用。請訪問 astrazeneca.com 並在社交媒體上關注該公司 @阿斯利康.

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References

參考文獻

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Adrian Kemp
Company Secretary
AstraZeneca PLC

阿德里安·坎普
公司秘書
阿斯利康有限公司

譯文內容由第三人軟體翻譯。


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