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在5年随访后，凯丽隆®联合内分泌治疗（ET）持续在无浸润性疾病生存率（iDFS）方面显示出显著且具有临床意义的获益1
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凯丽隆®仍是目前唯一在广泛的HR+/HER2-早期乳腺癌（EBC）患者人群（包括淋巴结阴性患者）中展现出一致且具临床意义获益的CDK4/6抑制剂1
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研究数据同时显示降低29.1%远处转移风险（DDFS），且总生存期（OS）呈现获益趋势*1
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在结束凯丽隆®治疗约两年（中位数）后，未观察到新的安全性信号1
诺华日前宣布了凯丽隆®（瑞波西利）关键性III期NATALEE研究的五年分析结果。数据显示，在完成为期三年的凯丽隆®治疗后约两年（中位随访时间：58.4个月），患者依然能够持续获益。结果显示，在接受Kisqali联合内分泌治疗（ET）的高复发风险II期和III期激素受体阳性/人表皮生长因子受体2阴性（HR+/HER2-）早期乳腺癌（EBC）广泛人群中，与ET单药相比，复发风险降低了28.4% (HR=0.716; 95% CI 0.618-0.829; P<0.0001)1。
凯丽隆®联合ET治疗组对比ET单药组的五年iDFS率为85.5% vs 81.0%，显示出具有临床意义的4.5%的改善1。该研究结果已于2025年欧洲肿瘤内科学会（ESMO）年会上公布。
都柏林圣文森特大学医院（St. Vincent’s University Hospital）肿瘤内科顾问医师、NATALEE研究者John Crown博士：“对于每年被诊断为早期乳腺癌的众多患者而言，对于复发风险及难以治愈的晚期疾病的恐惧，常常令患者及其家庭备受压力。这项为期五年的结果显示，患者在使用瑞波西利治疗结束后仍可长期持续获益，为这些高风险患者带来了更多实现无乳腺癌生存的机会。”
随着后期随访的推进，置信区间（CI）还将进一步收窄1。该趋势在各临床相关亚组中均保持一致，进一步证实了所观察到的iDFS获益1。
诺华全球肿瘤与血液疾病研发代理负责人Dushen Chetty：“这些数据进一步印证了凯丽隆®可显著降低乳腺癌的长期复发风险，即便在三年治疗期之后，患者仍可长期获益。这为医生和患者在长期疾病管理上带来了更多信心。凯丽隆®正在重新定义辅助治疗的标准，其中也包括淋巴结阴性人群。凭借在晚期与早期乳腺癌治疗中观察到的一致获益，以及凯丽隆®已确立的安全性特征，凯丽隆®是目前拥有最全面III期临床研究循证证据、且能够改善患者结局的CDK4/6抑制剂。”
总生存期（OS）持续展现积极趋势，风险比（HR）进一步改善至0.800，置信区间收窄（95% CI：0.637-1.003；单侧名义p值0.026），与最终iDFS分析（OS HR = 0.892（0.661-1.203））相比，显示与内分泌治疗（ET）单药组相比，死亡风险降低了20%1。NATALEE研究将继续随访，以确保OS及其他长期终点数据更为充分。
在所有患者完成凯丽隆®治疗约两年（中位数）后，长期安全性数据显示未发现新的安全性信号1。总体来看，继发性原发恶性肿瘤（SPM）发生率分别为2.7% （凯丽隆®+ET组）与3.0%（ET单药组），且各组均有1例因SPM导致死亡1。
凯丽隆®仍是目前唯一在三项HR+HER2-晚期乳腺癌一线治疗随机对照试验（MONALEESA-2、MONALEESA-3和MONALEESA-7）中均显示出具有统计学意义的显著OS获益的CDK4/6抑制剂2-12。
关于NATALEE研究
NATALEE是一项全球、III期、多中心、随机、开放标签的临床研究，旨在评估凯丽隆®联合内分泌治疗（ET）作为辅助治疗相较ET单药在广泛的II期和III期HR+/HER2-早期乳腺癌（EBC）患者中的疗效和安全性，该研究与TRIO合作开展13,14。两组的辅助内分泌治疗均为非甾体类芳香化酶抑制剂（NSAI；阿那曲唑或来曲唑），如适用可合并戈舍瑞林13,14。NATALEE研究的主要终点为无浸润性疾病生存率（iDFS），按照疗效终点评价标准（STEEP）进行定义13,14。共有5,101名HR+/HER2-早期乳腺癌成年患者在全球20个国家参与了该试验13,14。
关于凯丽隆®（瑞波西利）
凯丽隆®（瑞波西利）是一种选择性细胞周期蛋白依赖性激酶抑制剂，通过抑制细胞周期蛋白依赖性激酶4和6（CDK4/6）的蛋白，来帮助减缓肿瘤进展。当这些蛋白质过度活化时，会使癌细胞快速生长和分裂。精准靶向CDK4/6有助于肿瘤控制。
凯丽隆®已获得全球100多个国家监管机构的批准用于乳腺癌治疗，包括美国食品药品监督管理局（FDA）和欧洲委员会15,16。在美国，凯丽隆®与芳香化酶抑制剂（AI）联用，适用于高复发风险的HR+/HER2- II期和III期早期乳腺癌成人患者的辅助治疗，以及HR+/HER2-晚期或转移性乳腺癌（MBC）成人患者的初始内分泌治疗（ET）；凯丽隆®也获批与氟维司群联用，在ET初始治疗或疾病进展后治疗转移性乳腺癌15。在欧盟，凯丽隆®联合AI获批用于高复发风险HR+/HER2-早期乳腺癌患者的辅助治疗；同时也获批用于HR+/HER2-晚期或转移性乳腺癌女性患者，与AI或氟维司群联合作为初始ET或疾病进展后的治疗16。在绝经前或围绝经期女性中，ET应联用黄体生成素释放激素激动剂15,16。
凯丽隆®在全球范围内针对早期乳腺癌的监管审批正在持续推进，包括最近获得中国国家药品监督管理局的批准17。 在晚期乳腺癌（MBC）领域，凯丽隆®在三项III期临床试验中持续显示出具有统计学意义的显著总生存期（OS）获益2-12。
凯丽隆®由诺华公司与Astex制药公司合作研发
凯丽隆®的详细处方信息请参见www.Kisqali.com
关于诺华乳腺癌
三十多年来，诺华始终站在推动乳腺癌患者科学进步的前沿，并与全球医疗界精诚合作，不断推动并改善临床实践。凭借业内最全面的乳腺癌产品组合和研发管线，诺华在最常见的HR+/HER2-乳腺癌新疗法及联合治疗的探索方面引领行业发展。
*五年NATALEE分析中的总生存期（OS）数据尚不成熟。
— 参考文献 —
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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.
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