With 5.6 months of additional follow-up and 78.3% of patients having completed Kisqali® (ribociclib) investigational treatment, the updated analysis shows sustained iDFS benefit and stability in secondary endpoints including overall survival (OS)1,2 iDFS benefit remains consistent across key patient subgroups; among patients with stage II and stage III tumors, Kisqali lowered risk by 30% and 24.5%, respectively1,2 Latest analysis continues to show a well-tolerated safety profile in line with previously reported results, and quality of life for Kisqali patients preserved vs.

经过5.6个月的额外随访，78.3%的患者完成了Kisqali®（ribociclib）研究性治疗，最新分析显示，iDFS在次要终点的持续获益和稳定性，包括总生存期（OS）1,2 iDFS获益在关键患者亚组中保持一致；在II期和III期肿瘤患者中，Kisqali分别将风险降低了30%和24.5%[1,2]。最新分析显示，与先前报道的结果一致，Kisqali患者的安全性良好，生活质量保持不变。

endocrine therapy (ET) alone1,2,3 Risk of recurrence remains a short and long term concern; one in eight women treated with ET alone in NATALEE likely to experience invasive disease at 3 years1,2 Kisqali is currently approved in the metastatic setting, where it has consistently demonstrated statistically significant OS benefit across three Phase III trials4-15; Novartis has filed NATALEE results with EMA and will submit these latest EBC data to the FDA by end of year Basel, December 8, 2023 – Novartis today announced results from an updated invasive disease-free survival (iDFS) analysis of the pivotal Phase III NATALEE trial, with a median follow-up of 33.3 months and following Kisqali® (ribociclib) treatment completion by 78.3% of patients.

内分泌治疗（ET）1,2,3复发风险仍然是短期和长期关注的问题；在纳塔利单独接受ET治疗的女性中，有八分之一可能在3年内经历侵袭性疾病1,2 Kisqali目前已被批准用于转移性环境，在三项III期试验中，它一直显示出统计学上显着的OS益处4-15；诺华已经向EMA提交了NATALEE结果，并将在2023年12月8日巴塞尔年底前向FDA提交这些最新的EBC数据-诺华今天宣布了关键的III期NATALEE试验的最新侵入性无病生存（iDFS）分析结果，中位随访时间为33.3个月，Kisqali®（ribociclib）治疗完成后78.3%的患者。

Results reinforce the benefit seen at the earlier interim analysis, with a 25.1% (HR=0.749; 95% CI: 0.628, 0.892; p=0.0006) reduction in risk of disease recurrence in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) treated with adjuvant Kisqali plus a non-steroidal aromatase inhibitor as standard endocrine therapy (ET) compared to ET alone1,2.

结果强化了早期中期分析所见的益处，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）患者的疾病复发风险降低25.1%（HR=0.749；95%CI:0.628,0.892；p=0.0006）与单独使用Kisqali加非甾体芳香化酶抑制剂作为标准内分泌治疗（ET）相比，使用Kisqali加非甾体芳香化酶抑制剂作为标准内分泌治疗（ET）1,2。

Late-breaking data from .

来自的最新中断数据。