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(nèi)分泌治療（ET）后，四年或更長時(shí)間內(nèi)未出現(xiàn)疾病進(jìn)展1。上述結(jié)果來自MONALEESA試驗(yàn)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(jìn)行報(bào)告。
MBC是指癌細(xì)胞已經(jīng)從乳腺擴(kuò)散到身體其他部位的乳腺癌。使用凱麗隆®的長期無進(jìn)展生存獲益在不同絕經(jīng)狀態(tài)的患者甚至是部分伴有不良預(yù)后因素（如肝臟轉(zhuǎn)移、≥3處轉(zhuǎn)移灶）的患者均有觀察到1。患者的中位無進(jìn)展生存期為 6.8 年1。中位總生存期尚不可估計(jì)。
凱麗隆®已在全部三項(xiàng)III期MONALEESA試驗(yàn)中顯示出具有統(tǒng)計(jì)學(xué)意義的顯著OS獲益2-12。
"根據(jù)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(shí)間內(nèi)無疾病進(jìn)展。我們的生物標(biāo)志物分析表明，一些臨床和基因組因素可能與這些反應(yīng)相關(guān)，這凸顯了精準(zhǔn)醫(yī)學(xué)在識別哪些患者可以從CDK4/6抑制劑治療中實(shí)現(xiàn)最大獲益的重要性。"該分析作者也是此次SABCS大會報(bào)告者美國紀(jì)念斯隆凱特琳癌癥中心乳腺腫瘤內(nèi)科醫(yī)生兼轉(zhuǎn)化腫瘤合作項(xiàng)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(shí)間的承諾。"諾華腫瘤開發(fā)全球負(fù)責(zé)人Mark Rutstein表示，"這一長期分析結(jié)果進(jìn)一步增強(qiáng)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(yīng)答相關(guān)的患者與生物標(biāo)志物特征
特征 |
長期應(yīng)答者（LTR） |
非長期應(yīng)答者（Non-LTR） |
趨勢解讀 |
中位年齡（歲） |
59.3 |
58.0 |
兩組年齡相當(dāng) |
絕經(jīng)后（%） |
78 |
78 |
絕經(jīng)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(zhuǎn)移灶（%） |
30 |
43 |
LTR中高病灶負(fù)荷患者較少 |
肝臟轉(zhuǎn)移（%） |
16 |
26 |
LTR中肝轉(zhuǎn)移較少見 |
僅骨轉(zhuǎn)移疾病（%） |
24 |
20 |
LTR中僅骨轉(zhuǎn)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(jù)進(jìn)一步印證了在降低遠(yuǎn)處復(fù)發(fā)風(fēng)險(xiǎn)方面的持續(xù)獲益
此外，諾華還公布了NATALEE五年試驗(yàn)隨訪的一個(gè)亞組分析結(jié)果。數(shù)據(jù)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(yuǎn)處無病生存期（DDFS）13。該結(jié)果在關(guān)鍵亞組中包括淋巴結(jié)陽性和陰性患者均保持一致，進(jìn)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(fù)發(fā)風(fēng)險(xiǎn)的治療選擇13,14。
關(guān)于諾華乳腺癌
三十多年來，諾華始終站在推動(dòng)乳腺癌患者科學(xué)進(jìn)步的前沿，并與全球醫(yī)療界精誠合作，不斷推動(dòng)并改善臨床實(shí)踐。諾華作為業(yè)界擁有最全面的乳腺癌產(chǎn)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(lǐng)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(xì)胞周期蛋白依賴性激酶抑制劑，通過抑制細(xì)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(jìn)展。當(dāng)這些蛋白質(zhì)過度活化時(shí)，會使癌細(xì)胞快速生長和分裂。精準(zhǔn)靶向CDK4/6有助于腫瘤控制。
凱麗隆®已獲得全球100多個(gè)國家監(jiān)管機(jī)構(gòu)的批準(zhǔn)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(fù)發(fā)風(fēng)險(xiǎn)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(zhuǎn)移性乳腺癌（MBC）成人患者的初始內(nèi)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(jìn)展后治療轉(zhuǎn)移性乳腺癌15。
凱麗隆®在全球范圍內(nèi)針對早期乳腺癌的監(jiān)管審批正在持續(xù)推進(jìn)，包括最近獲得中國國家藥品監(jiān)督管理局的批準(zhǔn)17。在MBC領(lǐng)域，凱麗隆®在三項(xiàng)III期臨床試驗(yàn)中持續(xù)顯示出具有統(tǒng)計(jì)學(xué)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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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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