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(lián)合內分泌治療（ET）后，四年或更長時間內未出現(xiàn)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(tài)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。患者的中位無進展生存期為 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(tǒng)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(yī)學在識別哪些患者可以從CDK4/6抑制劑治療中實現(xiàn)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(yī)生兼轉化腫瘤合作項目主任Pedram Razavi博士如是說。
"凱麗隆®持續(xù)兌現(xiàn)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(fā)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(tài)分布均衡 |
新發(fā)晚期（de novo）（%） |
43 |
40 |
基線疾病狀態(tài)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(huán)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(shù)據進一步印證了在降低遠處復發(fā)風險方面的持續(xù)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(shù)據顯示，凱麗隆®聯(lián)合非甾體類芳香化酶抑制劑（NSAI）與單用NSAI相比，能夠持續(xù)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(lián)合NSAI 是降低最廣泛HR+/HER2-的EBC患者群體復發(fā)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(yī)療界精誠合作，不斷推動并改善臨床實踐。諾華作為業(yè)界擁有最全面的乳腺癌產品組合及研發(fā)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(lián)合用藥探索方面引領行業(yè)發(fā)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(jiān)管機構的批準用于乳腺癌治療，包括美國食品藥品監(jiān)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(lián)用，適用于高復發(fā)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(lián)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(jiān)管審批正在持續(xù)推進，包括最近獲得中國國家藥品監(jiān)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(xù)顯示出具有統(tǒng)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(fā)。
References |
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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. |
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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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