最近在2024年欧洲肿瘤内科学会（ESMO）大会上发布的NATALEE试验的最新分析进一步巩固了FDA审查的数据。结果显示，三年治疗期后患者获益进一步加深，与单独接受ET的患者相比，Kisqali组合疗法组患者复发风险降低了28.5%（HR=0.715；95% CI：0.609，0.840；P<0.0001）。诺华将继续对NATALEE患者进行长期结果的评估，包括总生存期。Novartis will continue to assess long-term outcomes for NATALEE patients, including overall survival.
According to the Zhito Finance APP, Novartis (NVS.US) announced today that the European Commission (EC) has approved the CDK4/6 inhibitor Kisqali (ribociclib) in combination with aromatase inhibitors (AI) as adjuvant therapy for patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer (EBC) at high risk of recurrence.
This approval is based on the results of the pivotal Phase 3 clinical trial NATALEE, which included a broad patient population, including patients with HR+/HER2- stage II and III early breast cancer, some of whom had no lymph node metastasis. The trial results showed that, compared to endocrine therapy (ET) alone, Kisqali combined with endocrine therapy significantly and clinically meaningfully reduced the risk of disease recurrence by 25.1% (HR=0.749; 95% CI: 0.628, 0.892; P=0.0006). Improvements in invasive disease-free survival (iDFS) were consistently observed across all patient subgroups.
The latest analysis of the NATALEE trial presented at the 2024 European Society for Medical Oncology (ESMO) conference further solidified the data for FDA review. The results indicated that after three years of treatment, patient benefits deepened, with a 28.5% reduction in the risk of recurrence for patients in the Kisqali combination therapy group compared to those receiving ET alone (HR=0.715; 95% CI: 0.609, 0.840; P<0.0001). Novartis will continue to assess long-term outcomes for NATALEE patients, including overall survival.
