瑞士巴塞爾2025年12月12日 /美通社/ -- 諾華宣布，有1/4的激素受體陽性、人表皮生長因子受體2陰性（HR+/HER2-）晚期乳腺癌（ABC）患者，在接受凱麗隆®（瑞波西利）聯合內分泌治療（ET）后，四年或更長時間內未出現疾病進展1。上述結果來自MONALEESA試驗中一線治療患者的匯總、事后探索性分析，已于2025年12月11日在圣安東尼奧乳腺癌研討會®（SABCS）上進行報告。
MBC是指癌細胞已經從乳腺擴散到身體其他部位的乳腺癌。使用凱麗隆®的長期無進展生存獲益在不同絕經狀態的患者甚至是部分伴有不良預后因素（如肝臟轉移、≥3處轉移灶）的患者均有觀察到1?；颊叩闹形粺o進展生存期為 6.8 年1。中位總生存期尚不可估計。
凱麗隆®已在全部三項III期MONALEESA試驗中顯示出具有統計學意義的顯著OS獲益2-12。
"根據最新的MONALEESA分析顯示，在MBC患者中，有 1/4的患者在四年或更長時間內無疾病進展。我們的生物標志物分析表明，一些臨床和基因組因素可能與這些反應相關，這凸顯了精準醫學在識別哪些患者可以從CDK4/6抑制劑治療中實現最大獲益的重要性。"該分析作者也是此次SABCS大會報告者美國紀念斯隆凱特琳癌癥中心乳腺腫瘤內科醫生兼轉化腫瘤合作項目主任Pedram Razavi博士如是說。
"凱麗隆®持續兌現了其有望為MBC患者帶來更長生存時間的承諾。"諾華腫瘤開發全球負責人Mark Rutstein表示，"這一長期分析結果進一步增強了我們對凱麗隆®能為MBC患者帶來臨床獲益的信心。"
與長期應答相關的患者與生物標志物特征
特征 |
長期應答者（LTR） |
非長期應答者（Non-LTR） |
趨勢解讀 |
中位年齡（歲） |
59.3 |
58.0 |
兩組年齡相當 |
絕經后（%） |
78 |
78 |
絕經狀態分布均衡 |
新發晚期（de novo）（%） |
43 |
40 |
基線疾病狀態相似 |
≥3處轉移灶（%） |
30 |
43 |
LTR中高病灶負荷患者較少 |
肝臟轉移（%） |
16 |
26 |
LTR中肝轉移較少見 |
僅骨轉移疾病（%） |
24 |
20 |
LTR中僅骨轉移略多見 |
ctDNA平均水平 |
0.05 |
0.13 |
LTR中循環腫瘤DNA水平更低 |
CCND1 基因改變（%） |
2 |
10 |
LTR中該基因改變較少見 |
TP53 基因改變（%） |
3 |
12 |
LTR中該基因改變較少見 |
Luminal A 型分子亞型（%） |
38 |
25 |
LTR中該亞型比例更高 |
NATALEE 5年數據進一步印證了在降低遠處復發風險方面的持續獲益
此外，諾華還公布了NATALEE五年試驗隨訪的一個亞組分析結果。數據顯示，凱麗隆®聯合非甾體類芳香化酶抑制劑（NSAI）與單用NSAI相比，能夠持續改善遠處無病生存期（DDFS）13。該結果在關鍵亞組中包括淋巴結陽性和陰性患者均保持一致，進一步鞏固了凱麗隆®聯合NSAI 是降低最廣泛HR+/HER2-的EBC患者群體復發風險的治療選擇13,14。
關于諾華乳腺癌
三十多年來，諾華始終站在推動乳腺癌患者科學進步的前沿，并與全球醫療界精誠合作，不斷推動并改善臨床實踐。諾華作為業界擁有最全面的乳腺癌產品組合及研發管線之一的公司，在HR+/HER2-乳腺癌這一最常見乳腺癌類型的新療法及聯合用藥探索方面引領行業發展。
凱麗隆®（瑞波西利）
凱麗隆®（瑞波西利）是一種選擇性細胞周期蛋白依賴性激酶抑制劑，通過抑制細胞周期蛋白依賴性激酶4和6（CDK4/6）的蛋白，來幫助減緩腫瘤進展。當這些蛋白質過度活化時，會使癌細胞快速生長和分裂。精準靶向CDK4/6有助于腫瘤控制。
凱麗隆®已獲得全球100多個國家監管機構的批準用于乳腺癌治療，包括美國食品藥品監督管理局（FDA）和歐洲委員會15,16。在美國，凱麗隆®與芳香化酶抑制劑（AI）聯用，適用于高復發風險的HR+/HER2- II期和III期早期乳腺癌成人患者的輔助治療，以及HR+/HER2-晚期或轉移性乳腺癌（MBC）成人患者的初始內分泌治療（ET）；凱麗隆®也獲批與氟維司群聯用，在ET初始治療或疾病進展后治療轉移性乳腺癌15。
凱麗隆®在全球范圍內針對早期乳腺癌的監管審批正在持續推進，包括最近獲得中國國家藥品監督管理局的批準17。在MBC領域，凱麗隆®在三項III期臨床試驗中持續顯示出具有統計學意義的顯著OS獲益2-12 。
凱麗隆®由諾華基于與Astex Pharmaceuticals的科研合作開發。
References |
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2. Yardley DA et al. Pooled exploratory analysis of survival in patients (pts) with HR+/HER2- advanced breast cancer (ABC) and visceral metastases (mets) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) trials. Poster presented at the European Society of Medical Oncology Congress. September 9-13, 2022. Paris, France. |
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8. Slamon DJ et al. Overall survival (OS) results of the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB). LBA7_PR. Presented at the European Society of Medical Oncology Congress. September 29, 2019. Barcelona, Spain. |
9. Slamon DJ et al. Updated overall survival (OS) results from the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with HR+/HER2? advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB). Presented at the American Society of Clinical Oncology Annual Meeting. June 5, 2021. Chicago, USA. |
10. Tripathy D et al. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with HR+/HER2? advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Presented at the San Antonio Breast Cancer Symposium. December 9, 2020. Texas, USA. |
11. Yardley D et al. Overall survival (OS) in patients (pts) with advanced breast cancer (ABC) with visceral metastases (mets), including those with liver mets, treated with ribociclib (RIB) plus endocrine therapy (ET) in the MONALEESA (ML) -3 and -7 trials. Presented at the American Society of Clinical Oncology Annual Meeting. June 2020. Chicago, USA. |
12. O'Shaughnessy J et al. Overall survival subgroup analysis by metastatic site from the Phase III MONALEESA-2 study of first-line ribociclib + letrozole in postmenopausal patients with HR+/HER2? advanced breast cancer. Presented at the San Antonio Breast Cancer Symposium. December 7-10, 2021. Texas, USA. |
13. Hurvitz S et al. Five-year analysis of distant disease-free survival (DDFS) across key subgroups from the phase 3 NATALEE trial of ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) in patients with HR+/HER2? _early breast cancer (EBC). Presented at the San Antonio Breast Cancer Symposium, December 11, 2025. Texas, USA. |
14. Crown J, Stroyakovskii D, Yardley DA, et al. Adjuvant Ribociclib Plus Nonsteroidal Aromatase Inhibitor Therapy in Patients With HR+/HER2? Early Breast Cancer: NATALEE 5-Year Outcomes. Presented at the European Society for Medical Oncology (ESMO) Congress; October 17-21, 2025; Berlin, Germany. |
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