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Truqap Plus Faslodex Approved in the EU for Patients With Advanced ER-positive Breast Cancer

Truqap Plus Faslodex Approved in the EU for Patients With Advanced ER-positive Breast Cancer

愛文思控股的Truqap Plus Faslodex已獲得歐盟批准，可用於治療ER陽性晚期乳腺癌患者。
阿斯利康 ·  06/20 12:00

First and only AKT inhibitor approved in the EU for breast cancer patients with specific biomarker alterations (PIK3CA, AKT1 or PTEN)

歐盟批准的第一種也是唯一一種用於具有特定生物標誌物改變（PIK3CA、AKT1 或 PTEN）的乳腺癌患者的AKT抑制劑

Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population

批准基於Capitello-291的結果，該結果顯示，在生物標誌物改變的人群中，與單獨使用Faslodex相比，這種組合可將疾病進展或死亡的風險降低50％

AstraZeneca's Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the European Union (EU) for the treatment of 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.

阿斯利康的 Truqap （capivasertib）與 Faslodex （fulvestrant）已獲歐盟（EU）批准用於治療雌激素受體（ER）陽性、HER2陰性的局部晚期或轉移性乳腺癌的成年患者，這些癌症伴有一種或多種 PIK3CA、AKT1 或 PTEN改變，在內分泌類療法中或之後復發或進展後。

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the CAPItello-291 Phase III trial published in The New England Journal of Medicine.1

歐盟委員會的批准遵循了 積極的看法 人用藥品委員會的成果，其基礎是 第 291 章 三期試驗發表於 《新英格蘭醫學雜誌》.1

In the trial, Truqap in combination with Faslodex reduced the risk of disease progression or death by 50% versus Faslodex in combination with placebo in patients with tumours harbouring PI3K, AKT or PTEN alterations (based on hazard ratio of 0.50, 95% confidence interval 0.38-0.65; p=<0.001; median progression-free survival (PFS) 7.3 versus 3.1 months).1

在審判中 Truqap 結合 Faslodex 與之相比，疾病進展或死亡的風險降低了50％ Faslodex 在患有PI3K、AKT或PTEN變異的腫瘤患者中與安慰劑聯合使用（基於0.50，95% 置信區間0.38-0.65；p=1

In Europe, breast cancer remains the leading cause of cancer death, with more than 140,000 deaths in 2022 and more than 550,000 patients diagnosed in the same year.2 Hormone receptor (HR)-positive breast cancer (expressing estrogen or progesterone receptors, or both), is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative.3 More than 97% of HR-positive breast cancer tumours are ER-positive.4,5 Collectively, mutations in PIK3CA, AKT1 and alterations in PTEN occur frequently, affecting approximately 50% of patients with advanced HR-positive breast cancer.6-8

在歐洲，乳腺癌仍然是癌症死亡的主要原因，2022年有超過14萬人死亡，同年有超過55萬名患者被確診。2 激素受體 (HR) 陽性乳腺癌（表達雌激素或孕酮受體，或兩者兼有）是乳腺癌最常見的亞型，70% 的腫瘤被認爲是 HR 陽性和 HER2 陰性。3 超過 97% 的 HR 陽性乳腺癌腫瘤是 ER 陽性。4,5 總的來說，PIK3CA、AKT1 的突變和 PTEN 的改變經常發生，影響約 50% 的晚期 HR 陽性乳腺癌患者。6-8

Mafalda Oliveira, MD, PhD, Vall d'Hebron University Hospital, and Senior Clinical Investigator of the Vall d'Hebron Institute of Oncology's Breast Cancer Group in Barcelona, Spain, said: "Patients with advanced ER-positive breast cancer typically experience tumour progression or resistance with widely used endocrine-based treatment regimens, and there is an urgent need to provide them more time with their disease under control. Today's approval is welcome news for approximately half of ER-positive breast cancer patients in Europe who have tumours with these biomarkers, and it is important for clinicians to test and identify eligible patients who may be able to benefit from this combination."

瓦爾·德希伯倫大學醫院醫學博士、西班牙巴塞羅那瓦爾·希伯倫腫瘤研究所乳腺癌小組高級臨床研究員瑪法爾達·奧利維拉說：“晚期ER陽性乳腺癌患者在廣泛使用的內分泌治療方案中通常會出現腫瘤進展或出現耐藥性，迫切需要爲他們提供更多時間來控制自己的疾病。對於歐洲大約一半患有這些生物標誌物的腫瘤的ER陽性乳腺癌患者來說，今天的批准是個好消息，對於臨床醫生來說，測試和確定可能能夠從這種組合中受益的合格患者非常重要。”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Truqap is now the first and only AKT inhibitor approved in the European Union for patients with ER-positive breast cancer who have tumours harbouring these specific biomarkers. Breast cancer continues to be the leading cause of cancer-related death in Europe, and today's news represents a significant step forward in providing an important new treatment option for patients in need of new, innovative therapies."

阿斯利康腫瘤學業務部執行副總裁戴夫·弗雷德裏克森說：”Truqap 現在是歐盟批准的第一種也是唯一一種用於腫瘤含有這些特定生物標誌物的ER陽性乳腺癌患者的AKT抑制劑。乳腺癌仍然是歐洲癌症相關死亡的主要原因，今天的新聞代表着在爲需要新的創新療法的患者提供重要的新治療選擇方面向前邁出的重要一步。”

In the CAPItello-291 trial, the safety profile of Truqap plus Faslodex was similar to that observed in previous trials evaluating this combination.1

在 Capitello-291 試驗中，的安全性概況 Truqap 加 Faslodex 與先前評估該組合的試驗中觀察到的結果相似。1

Regulatory applications are currently under review in China and several other countries. Similar indications for Truqap in combination with Faslodex are already approved in the US, Japan and several other countries based on the CAPItello-291 trial.

中國和其他幾個國家的監管申請目前正在審查中。類似的適應症 Truqap 結合 Faslodex 已獲批准 我們, 日本 以及其他幾個基於Capitello-291試驗的國家。

Financial considerations
Following this approval in the EU, Astex Therapeutics is eligible to receive a milestone payment from AstraZeneca on first commercial sale of the drug in the EU as well as royalties on future sales in line with the agreement between the two companies.

財務方面的考慮
在歐盟獲得批准後，Astex Therapeutics有資格獲得阿斯利康在歐盟首次商業銷售該藥物的里程碑式付款，以及根據兩家公司之間的協議獲得未來銷售的特許權使用費。

Notes

注意事項

HR-positive breast cancer
The growth of HR-positive breast cancer cells is often driven by estrogen receptors, and endocrine therapies that target ER-driven disease are widely used as 1st-line treatment in the advanced setting, and often paired with CDK4/6 inhibitors.9-11 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.10 Once this occurs, treatment options are limited– with chemotherapy being the current standard of care – and survival rates are low with approximately 35% of patients anticipated to live beyond five years after diagnosis.3,10,12

HR 陽性乳腺癌
HR 陽性乳腺癌細胞的生長通常由雌激素受體驅動，針對急診室驅動疾病的內分泌療法在晚期環境中被廣泛用作一線治療，通常與CDK4/6抑制劑配合使用。9-11 但是，許多晚期疾病患者會出現對CDK4/6抑制劑和當前內分泌療法的耐藥性。10 一旦發生這種情況，治療選擇就會受到限制— 化療是目前的護理標準 — 存活率很低，預計約有35％的患者在診斷後的壽命將超過五年。3,10,12

The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research.

優化內分泌療法、克服耐藥性以使患者能夠繼續從這些治療中受益，以及爲不太可能受益的患者尋找新的療法，是乳腺癌研究的積極關注領域。

CAPItello-291
CAPItello-291 is a Phase III, double-blind, randomised trial evaluating the efficacy of Truqap in combination with Faslodex versus placebo plus Faslodex for the treatment of locally advanced (inoperable) or metastatic HR-positive (ER-positive and ER-positive, progesterone receptor-positive), HER2-low or negative (immunohistochemistry (IHC) 0 or 1+, or IHC 2+/in-situ hybridisation (ISH)-negative) breast cancer.

第 291 章
Capitello-291 是一項 III 期雙盲隨機試驗，旨在評估其療效 Truqap 結合 Faslodex 對比安慰劑+ Faslodex 用於治療局部晚期（不可手術）或轉移性 HR 陽性（ER 陽性和 ER 陽性，孕酮受體陽性）、HER2 低或陰性（免疫組織化學 (IHC) 0 或 1+，或 IHC 2+/原位雜交 (ISH) 陰性）乳腺癌。

The global trial enrolled 708 adult patients with histologically confirmed HR-positive, HER2-low or negative breast cancer whose disease has recurred or progressed during or after aromatase inhibitor therapy, with or without a CDK4/6 inhibitor, and up to one line of chemotherapy for advanced disease. The trial has dual primary endpoints of PFS 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). In the trial, approximately 40% of tumours had these alterations and approximately 70% of patients received a prior CDK4/6 inhibitor.

該全球試驗招收了708名組織學確診的HR陽性、HER2低或陰性的乳腺癌的成年患者，這些患者在芳香化酶抑制劑治療期間或之後復發或進展，無論是否使用CDK4/6抑制劑，以及多達一條晚期疾病化療系列。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，PFS的兩個主要終點是PFS。在試驗中，大約40％的腫瘤有這些改變，大約70％的患者先前接受了CDK4/6抑制劑。

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, EU, Japan and several other countries for the treatment of adult patients with HR-positive (or ER-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，美國、歐盟、日本和其他幾個國家批准用於治療在內分泌治療方案中或之後復發或進展後伴有一種或多種生物標誌物改變（PIK3CA、AKT1或PTEN）的HR陽性（或ER陽性）、HER2陰性的局部晚期或轉移性乳腺癌的成年患者。 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。

Faslodex
Faslodex is an endocrine therapy indicated for the treatment of ER-positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on anti-estrogen therapy.

Faslodex
Faslodex 是一種內分泌療法，適用於以前未接受過內分泌療法治療的絕經後女性進行ER陽性、局部晚期或轉移性乳腺癌，或者在輔助抗雌激素治療期間或之後出現疾病復發或抗雌激素治療後疾病進展的女性。

In the US, EU and Japan, Faslodex is also approved in combination with CDK4/6 inhibitors for the treatment of women with HR-positive, HER2-negative advanced or metastatic breast cancer, whose cancer has progressed after endocrine medicine. Faslodex represents a hormonal treatment approach that helps to slow tumour growth by blocking and degrading the estrogen receptor – a key driver of disease progression.

在美國、歐盟和日本，Faslodex 還獲准與CDK4/6抑制劑聯合使用，用於治療患有HR陽性、HER2陰性的晚期或轉移性乳腺癌的女性，其癌症在內分泌藥物治療後出現進展。Faslodex 代表一種激素治療方法，通過阻斷和降解雌激素受體來幫助減緩腫瘤的生長，雌激素受體是疾病進展的關鍵驅動力。

Faslodex is approved as monotherapy or in combination with medicines from various drug classes including CDK4/6, PI3K and AKT inhibitors for the treatment of patients with HR-positive advanced breast cancer and is being evaluated in combination with medicines from other drug classes.

Faslodex 獲准作爲單一療法或與各種藥物類別的藥物聯合使用，包括CDK4/6、PI3K和AKT抑制劑，用於治療HR陽性晚期乳腺癌患者，目前正在與其他藥物類別的藥物聯合使用。

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陽性和低HER2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's innovative medicines are sold in more than 125 countries and 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。阿斯利康的創新藥物總部位於英國劍橋，銷往超過125個國家，全球有數百萬患者使用。請訪問 astrazeneca.com 並在社交媒體上關注該公司 @AstraZeneca

Contacts
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References

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譯文內容由第三人軟體翻譯。


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