AstraZeneca And Daiichi Sankyo Company Announce The First Patient Was Dosed In The Global TROPION-Breast01 Phase 3 Trial Evaluating The Efficacy And Safety Of Datopotamab Deruxtecan
AstraZeneca And Daiichi Sankyo Company Announce The First Patient Was Dosed In The Global TROPION-Breast01 Phase 3 Trial Evaluating The Efficacy And Safety Of Datopotamab Deruxtecan
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the first patient was dosed in the global TROPION-Breast01 phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd), a TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (NASDAQ:AZN), in patients with hormone receptor (HR) positive, human epidermal growth factor 2 receptor (HER2) negative inoperable or metastatic breast cancer previously treated with chemotherapy.
第一三共股份有限公司（以下簡稱第一三峽）今天宣布，第一名患者在全球對 Tropion-乳房 01 3 期試驗中用藥，該試驗評估了由大一三協和納斯達康（NASDAAZN）共同開發的 Dotopotamab 德魯克斯特康（DATO DxD）的有效性和安全性患者的激素受體 (HR) 陽性, 人表皮生長因子 2 受體 (HER2) 陰性無法手術或轉移性乳腺癌先前用化療治療. TROP2
Breast cancer is the most common cancer worldwide with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 Approximately 70% of all breast cancers are considered HR positive, HER2 negative.2 For patients with HR positive, HER2 negative metastatic breast cancer that progresses on or is not suitable for hormone therapy-based regimens, current standard of care is single-agent chemotherapy, which demonstrates diminishing efficacy with each subsequent line of treatment.3
乳腺癌是全球最常見的癌症，在 2020 年確診超過 200 萬例，導致全球近 685,000 人死亡。1 約 70% 的乳腺癌被視為 HR 陽性。2 對於 HR 陽性患者，HER2 陰性轉移性乳腺癌正在進行或不適合以激素療法為基礎的方案，目前的護理標準是單一劑藥物治療，其後每一種治療方案都可顯示化療效減退。步驟 3
"There are no TROP2 directed therapies currently approved for HR positive, HER2 negative breast cancer and we are encouraged by the emerging clinical profile of datopotamab deruxtecan in patients with breast cancer," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "TROPION-Breast01 is the first pivotal trial of datopotamab deruxtecan in breast cancer and the third pivotal study in our clinical development program, underscoring our efforts to accelerate development of this TROP2 directed ADC in breast and lung cancer."
大一三峽腫瘤科研發全球總監 FOPQ 博士，Gilles Gallant 博士，FOPQ 博士，Gilles Gallant 表示：「目前尚未獲得 TROP2 針對人力資源陽性治療的批准，HER2 陰性乳腺癌，我們受到鼓舞。「Tropion-乳房01 是達托泊抗 deruxteCAN 在乳腺癌中的第一個關鍵試驗，也是我們臨床開發計劃中的第三項關鍵研究，強調了我們努力加速這種 TROP2 針對 ADC 在乳腺癌和肺癌的發展。」
"Most patients with HR positive, HER2 negative metastatic breast cancer will inevitably progress on available treatments, including hormonal therapy and standard of care chemotherapy. In this setting, the unmet need is high, and new therapeutic approaches are necessary to delay disease progression and extend survival," said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. "The TROPION-Breast01 trial will evaluate whether datopotamab deruxtecan may be a more effective treatment than chemotherapy for patients with previously treated HR positive, HER2 negative advanced breast cancer previously treated with one to two lines of chemotherapy."
「大多數 HR 陽性 HER2 陰性轉移性乳腺癌患者將不可避免地在可用的治療方法上進行，包括荷爾蒙治療和護理化療標準。在這種情況下，未滿足的需求很高，並且需要新的治療方法來延緩疾病進展和延長生存。」阿斯利康首席醫學官兼腫瘤科首席開發官克里斯蒂安·馬薩塞西（Cristian Massacesi）表示。「對於先前治療過的 HR 陽性，HER2 陰性晚期乳腺癌的患者，對於先前經過一至兩行化療治療的 HER2 陰性晚期乳腺癌的患者來說，對於治療，對於治療，對於治療，對於治療，對於治療，對於治療，對於先前治療的患者來說，達托泊馬抗德克昔康是否比化療更有效
譯文內容由第三人軟體翻譯。