将有數據顯示潛在first-in-class AKT抑制劑capivasertib和新一代口服 SERD camistrant在HR陽性晚期乳腺癌中的臨床機會
Enhertu臨床數據進一步增強其重塑靶向HER2疾病新标準的潛力
抗體偶聯藥物datopotamab deruxtecan 的數據将證明其在HR陽性和三陰性乳腺癌中的潛力
阿斯利康将在2022年12月6日至10日舉行的2022年聖安東尼奧乳腺癌大會 (SABCS) 上展示新數據，以彰顯其重新定義癌症治療的雄心。
12種阿斯利康獲批藥物和潛在新藥将在55場展示中亮相，其中包括5場口頭演講，展示了阿斯利康在不同亞型和分期乳腺癌中日益增長的領導地位。
阿斯利康全球執行副總裁，腫瘤治療領域研發負責人Susan Galbraith表示：“阿斯利康在SABCS上展示的數據有力地證明了我們為幾乎所有主要類型的乳腺癌患者提供新一代治療解決方案的臨床策略。我們很高興分享CAPItello-291試驗的關鍵結果，讓我們的新型AKT抑制劑capivasertib為HR陽性患者提供治療選擇。我們也期待展示 SERENA-2 II期試驗數據，這些數據将證明我們的新一代SERD camizestrant有望改善ER驅動乳腺癌患者目前可用的内分泌療法。”
阿斯利康全球執行副總裁，腫瘤事業部負責人Dave Fredrickson表示：“正值阿斯利康又一年乳腺癌突破之際，在SABCS的展示将代表我們的産品組合有望塑造臨床實踐并重新定義乳腺癌跨亞型和分期的治療。潛在新藥capivasertib和camistrant令人信服的結果，以及抗體偶聯藥物Enhertu（通用名：德曲妥珠單抗）和datopotamab deruxtecan的最新數據也進一步堅定阿斯利康緻力于解決未滿足需求并為更多乳腺癌患者提供個性化治療的決心。”
以重塑HER2陽性轉移性乳腺癌治療新标準為目标
DESTINY-Breast臨床研究的兩個最新報告将重點聚焦德曲妥珠單抗治療HER2陽性轉移性乳腺癌患者的療效。
DESTINY-Breast03 III期試驗關于德曲妥珠單抗與恩美曲妥珠單抗 (trastuzumab emtansine，簡稱T-DM1) 分别治療既往接受過曲妥珠單抗和紫杉烷治療的HER2陽性乳腺癌患者的結果，包括無進展生存期 (PFS) 數據和總生存期 (OS) 結果将在此次大會上公布。
此外，還将公布 DESTINY-Breast02 III 期試驗的主要結果，進一步證明德曲妥珠單抗與傳統化療方案相比，對既往接受T-DM1治療的HER2陽性轉移性乳腺癌患者的臨床獲益。
ROSET-BM回顧性研究和DEBBRAH II期試驗的數據也将公布，進一步證實德曲妥珠單抗在HER2陽性或HER2低表達伴活動性或穩定腦轉移的轉移性乳腺癌患者中的活性。
重塑HR陽性晚期乳腺癌治療新期待
一份最新報告将介紹阿斯利康聚焦晚期HR陽性乳腺癌的内分泌耐藥性問題。
CAPItello-291 III期試驗關于AKT抑制劑capivasertib聯合芙仕得（通用名：氟維司群）與芙仕得單藥治療内分泌耐藥、HR 陽性、HER2低表達或陰性晚期乳腺癌的詳細數據即将公布。CAPItello-291試驗最近兩個主要終點均已達到，在整體患者群和預先指定的生物标記物亞組（PIK3CA、AKT1或PTEN基因突變）患者群的PFS均有所改善。
以下報告和展示将确立新一代口服選擇性雌激素受體降解劑 (SERD) camizestrant作為單藥療法或聯合療法治療雌激素受體陽性（ER陽性）晚期乳腺癌患者的臨床潛力。
· 最新的大會口頭報告将重點介紹camistrant與氟維司群在晚期ER陽性乳腺癌中的陽性 SERENA-2 II 期試驗的詳細結果。
· 還将介紹對晚期ER陽性乳腺癌的SERENA-1 I期試驗的進一步的隊列分析，将顯示camistrant與阿貝西利（一種 CDK4/6 抑制劑）聯合使用的潛力。
· 聚光燈海報将展示在ESR1野生型和突變型中與CDK4/6、mTOR、AKT或 PI3K 抑制劑雙重和三重聯合使用時，camistrant在ER陽性乳腺癌中具有前景的臨床前活性。
此外，大會還有幾場展示體現阿斯利康緻力于通過抗體偶聯藥物 (ADC)建立可能對靶向治療産生反應的新腫瘤亞型，改變HR陽性乳腺癌治療格局。
· TROPION-PanTumor01 I期試驗結果的海報展示将描述datopotamab deruxtecan在經過多線治療後的HR陽性、HER2陰性不可手術或轉移性乳腺癌患者中的安全性和令人鼓舞的臨床活性。TROPION-Breast01 III期随機臨床試驗正在檢驗datopotamab deruxtecan對于更早線患者的療效。
· 多個海報展示将分享具有潛力的診斷工具的結果，以更好地識别和優化具有不同HER2表達水平患者的治療，包括可能受益于德曲妥珠單抗治療的HER2低表達腫瘤患者。
· 來自DESTINY-Breast04 III 期試驗的各種亞組分析的數據将加強HER2低表達作為轉移性乳腺癌患者中可靶向人群的臨床意義。
重新定義三陰性乳腺癌 (TNBC) 的治療
兩個聚光燈海報讨論将分享BEGONIA Ib / II期試驗的結果，該試驗用于評估英飛凡（通用名：度伐利尤單抗）聯合療法對于晚期或轉移性TNBC的效果，有望通過與ADC聯用來改善患者結局。
此外，來自datopotamab deruxtecan單藥療法的TROPION-PanTumor01 I期試驗的更新結果将顯示令人鼓舞和持久的抗腫瘤活性，以及在經過多線治療的轉移性 TNBC 患者中的安全可控性。TROPION-Breast02 III期臨床試驗正在評估datopotamab deruxtecan作為轉移性TNBC患者的一線治療。
德曲妥珠單抗和datopotamab deruxtecan是阿斯利康與第一三共在全球範圍内合作開發和商業化的，但第一三共在日本單獨保留市場的專有權。
阿斯利康在SABCS 2022上的關鍵展示
主要作者 |
摘要标題 |
演講/展示信息 |
HER2陽性乳腺癌 |
||
Krop, I |
Trastuzumab deruxtecan vs physician’s choice in patients with HER2+ unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine: primary results of the randomized phase 3 study DESTINY-Breast02 |
Presentation #GS2-01 Oral Presentation – General Session 2 7 December 2022 09:00 – 09:15 CT 15:00 – 15:15 GMT |
Hurvitz, SA |
Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: Updated survival results of the randomized, phase 3 study DESTINY-Breast03 |
Presentation #GS2-02 Oral Presentation – General Session 2 7 December 2022 09:15 – 09:30 CT 15:15 – 15:30 GMT
|
Takashi, Y |
Trastuzumab deruxtecan for the treatment of patients with HER2-positive breast cancer with brain and/or leptomeningeal metastases: A multicenter retrospective study (ROSET-BM study) |
Presentation #PD7-01 Spotlight Poster Discussion 7 7 December 2022 17:00 CT 23:00 GMT
|
Hamilton, EP |
Dose-expansion study of Trastuzumab Deruxtecan as monotherapy or combined with Pertuzumab in patients With metastatic human epidermal growth factor receptor 2-positive (HER2+) breast cancer in DESTINY-Breast07 (DB-07) |
Presentation #PD18-11 Spotlight Poster Discussion 18 9 December 2022 07:00 CT 13:00 GMT
|
Varghese, D |
A real-world evidence study of treatment patterns in patients with HER2-positive metastatic breast cancer who have received at least 2-lines of therapy |
Presentation #P1-11-19 Poster Session 1 6 December 2022 17:00 CT 23:00 GMT
|
Lam, C |
Treatment patterns and outcomes among patients with HER2-postive metastatic breast cancer in the United States |
Presentation #P4-03-34 Poster Session 4 8 December 2022 07:00 CT 13:00 GMT
|
Henderson, M |
Adverse events (AEs) in phase III clinical trials of patients with human epidermal growth factor receptor-2 positive (HER2+) breast cancer (BC): a meta-analysis |
Presentation #P4-07-53 Poster Session 4 8 December 2022 07:00 CT 13:00 GMT
|
Lin, NU |
Open-label, phase 3b/4 study of trastuzumab deruxtecan (T-DXd) in patients with or without baseline brain metastasis with advanced/metastatic human epidermal growth factor receptor 2–positive breast cancer: DESTINY-Breast12 |
Presentation #OT2-16-02 Ongoing Trials Poster Session 2 7 December 2022 17:00 CT 23:00 GMT
|
HER2低表達乳腺癌 |
||
Prat, A |
Determination of HER2-low status in tumors of patients with unresectable and/or metastatic breast cancer in DESTINY-Breast04 |
Presentation #HER2-18 HER2 Low: A Separate Entity Special Poster Session 7 December 2022 09:45 – 11:00 CT 15:45 – 17:00 GMT
|
Viale, G |
Retrospective Study to Estimate the Prevalence and Describe the Clinicopathological Characteristics, Treatment Patterns, and Outcomes of HER2-Low Breast Cancer |
Presentation #HER2-15 HER2 Low: A Separate Entity Special Poster Session 7 December 2022 09:45 – 11:00 CT 15:45 – 17:00 GMT |
Rüschoff, J |
Proficiency assessment of HER2-low breast cancer scoring with the Ventana PATHWAY 4B5 and Dako HercepTest HER2 assays and the impact of pathologist training |
Presentation #HER2-13 HER2 Low: A Separate Entity Special Poster Session 7 December 2022 09:45 – 11:00 CT 15:45 – 17:00 GMT |
Schmid, P |
Trastuzumab deruxtecan (T-DXd) + durvalumab (D) as first-line (1L) treatment for unresectable locally advanced/metastatic hormone receptor-negative (HR−), HER2-low breast cancer: updated results from BEGONIA, a phase 1b/2 study |
Presentation #PD11-08 Spotlight Poster Discussion 11 8 December 2022 07:00 CT 13:00 GMT |
Pérez-García, JM |
Trastuzumab Deruxtecan in patients with Unstable Central Nervous System Involvement from HER2-Low Advanced Breast Cancer: The DEBBRAH Trial |
Presentation #PD7-02 Spotlight Poster Discussion 7 7 December 2022 17:00 CT 23:00 GMT
|
Harbeck, N |
Trastuzumab deruxtecan vs treatment of physician’s choice in patients with HER2-low unresectable and/or metastatic breast cancer: Subgroup analyses from DESTINY-Breast04 |
Presentation #P1-11-01 Poster Session 1 6 December 2022 17:00 CT 23:00 GMT |
Spitzmüller, A |
Computational pathology based HER2 expression quantification in HER2-low breast cancer |
Presentation #P6-04-03 Poster Session 6 9 December 2022 07:00 CT 13:00 GMT |
Tsirka, A |
High Intra- and Inter-block concordance of HER2 immunohistochemistry (IHC) scores across breast cancer samples and impact of decalcification procedures |
Presentation #P6-04-17 Poster Session 6 9 December 2022 07:00 CT 13:00 GMT |
Globerson, Y |
A fully automatic artificial intelligence system for accurate and reproducible HER2 IHC scoring in breast cancer |
Presentation #P6-04-05 Poster Session 6 9 December 2022 07:00 CT 13:00 GMT |
Kapil, A |
ART: Automated Region segmentation of Tumor on HER2-stained breast cancer tissue |
Presentation #P6-04-16 Poster Session 6 9 December 2022 07:00 CT 13:00 GMT |
HR陽性乳腺癌 |
||
Hurvitz, SA |
TRIO-US B-12 TALENT: Neoadjuvant trastuzumab deruxtecan with or without anastrozole for HER2-low, HR+ early stage breast cancer |
Presentation #GS2-03 Oral Presentation – General Session 2 7 December 2022 09:30 – 09:45 CT 15:30 – 15:45 GMT |
Oliveira, M |
Camizestrant, a next generation oral SERD vs fulvestrant in post-menopausal women with advanced ER-positive HER2-negative breast cancer: Results of the randomized, multi-dose Phase 2 SERENA-2 trial |
Presentation #GS3-02 Oral Presentation – General Session 3 8 December 2022 08:45 – 09:00 CT 14:45 – 15:00 GMT |
Turner, NC |
Capivasertib and fulvestrant for patients with aromatase inhibitor-resistant hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: results from the Phase III CAPItello-291 trial |
Presentation #GS3-04 Oral Presentation – General Session 3 8 December 2022 09:15 – 09:30 CT 15:15 – 15:30 GMT |
Meric-Bernstam, F |
Phase 1 TROPION-PanTumor01 Study evaluating Datopotamab Deruxtecan (Dato-DXd) in unresectable or metastatic hormone receptor–positive/HER2–negative breast cancer (BC) |
Presentation #PD13-08 Spotlight Poster Discussion 13 8 December 2022 17:00 CT 23:00 GMT
|
Carnevalli, L |
Combination of the next generation oral SERD camizestrant (AZD9833) with CDK4/6 and mTOR/AKT inhibitors delivers robust efficacy in a broad range of ER+ breast tumors |
Presentation #PD10-04 Spotlight Poster Discussion 10 8 December 2022 07:00 CT 13:00 GMT
|
Morrow, C |
The next generation oral selective estrogen receptor degrader (SERD) camizestrant (AZD9833) is active against wild type and mutant estrogen receptor α |
Presentation #P3-07-13 Poster Session 3 7 December 2022 17:00 CT 23:00 GMT
|
Bardia, A |
Datopotamab deruxtecan (Dato-DXd), a TROP2 antibody-drug conjugate,vs investigators’ choice of chemotherapy in previously-treated, inoperable or metastatic HR+/HER2–breast cancer: TROPION-Breast01 |
Presentation #OT1-03-04 Ongoing Trials Poster Session 1 6 December 2022 17:00 CT 23:00 GMT
|
Turner, NC |
SERENA-1: Updated analyses from a Phase 1 study of the next generation oral selective estrogen receptor degrader camizestrant (AZD9833) combined with abemaciclib, in women with ER-positive, HER2-negative advanced breast cancer |
Presentation #OT2-02-01 Ongoing Trials Poster Session 2 7 December 2022 17:00 CT 23:00 GMT |
三陰性及BRCA突變乳腺癌 |
||
Schmid, P |
Datopotamab deruxtecan (Dato-DXd) + durvalumab (D) as first-line (1L) treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): updated results from BEGONIA, a phase 1b/2 study |
Presentation #PD11-09 Spotlight Poster Discussion 11 8 December 2022 07:00 CT 13:00 GMT |
Bardia, A |
Datopotamab Deruxtecan (Dato-DXd) in advanced triple-negative breast cancer (TNBC): Updated results from the Phase 1 TROPION-PanTumor01 Study |
Presentation #P6-10-03 Poster Session 6 9 December 2022 07:00 CT 13:00 GMT |
Copson, ER |
Expert consensus on the definition of high risk of recurrence in HER2-negative eBC: a modified Delphi panel |
Presentation #P3-05-39 Poster Session 3 7 December 2022 17:00 CT 23:00 GMT |
Dent, R |
TROPION-Breast02: Phase 3, open-label, randomized study of first-line datopotamab deruxtecan versus chemotherapy in patients with locally recurrent inoperable or metastatic TNBC who are not candidates for anti-PD-(L)1 therapy |
Presentation #OT1-03-05 Ongoing Trials Poster Session 1 6 December 2022 17:00 CT 23:00 GMT |
Balmaña, J |
OlympiaN: a phase 2, multicenter, open-label study to assess the efficacy and safety of neoadjuvant olaparib monotherapy and olaparib plus durvalumab in patients with BRCA mutations and early-stage HER2-negative breast cancer |
Presentation #OT2-18-02 Ongoing Trials Poster Session 2 7 December 2022 17:00 CT 23:00 GMT |
關于阿斯利康在乳腺癌領域的研究
随着對乳腺癌生物學的日益了解，阿斯利康開始挑戰和重新定義乳腺癌的分類及臨床治療模式，以提供給患者所需的更為精準而有效的治療方案。阿斯利康雄心勃勃，希望有朝一日可以消除乳腺癌這一緻死病因。
阿斯利康研發了一系列已獲批或有望獲批的藥物，通過多種機制應對乳腺癌腫瘤微環境的生物多樣性。
憑借德曲妥珠單抗，一種靶向HER2的抗體偶聯藥物，阿斯利康和第一三共的目标是改善先前治療的HER2陽性和HER2低表達轉移性乳腺癌的結果，并正在探索其在更早線的治療和新型乳腺癌中的潛力。
在HR陽性乳腺癌中，阿斯利康繼續持續依托基石藥物氟維司群和戈舍瑞林改善預後，并旨在通過 ngSERD camizestrant和潛在新藥AKT激酶抑制劑capivasertib重塑HR陽性乳腺癌治療。同時，阿斯利康與第一三共合作，探索 TROP2靶向ADC datopotamab deruxtecan的潛在療效。
PARP抑制劑奧拉帕利是一種靶向治療選擇，已在遺傳性BRCA突變的HER2陰性早期和轉移性乳腺癌患者中進行了研究。阿斯利康和默沙東持續探索奧拉帕利在BRCA遺傳突變的轉移性乳腺癌患者中的效果，同時正尋求新的契機使這類患者在疾病更早期接受治療。
為了滿足三陰性乳腺癌患者對更多治療選擇的迫切需求，阿斯利康正在評估免疫藥物度伐利尤單抗與奧拉帕利、德曲妥珠單抗等與其他腫瘤藥物聯合用藥的效果，評估AKT激酶抑制劑capivasertib與化療聯用，capivasertib和datopotamab deruxtecan聯用的潛在效果。
關于阿斯利康在腫瘤領域的研究
阿斯利康正引領着腫瘤領域的一場革命，緻力提供多元化的腫瘤治療方案，以科學探索腫瘤領域的複雜性，發現、研發并向患者提供改變生命的藥物。
阿斯利康專注于最具挑戰性的腫瘤疾病，通過持續不斷的創新，阿斯利康已經建立了行業領先的多元化的産品組合和管線，持續推動醫療實踐變革，改變患者體驗。
阿斯利康以期重新定義癌症治療并在未來攻克癌症。
聲明
本文涉及研究中的藥品用法尚未在中國獲批适應症，阿斯利康不推薦任何未被批準的藥品使用。
内容來源：新聞稿（内部審批号：CN-106415）