Basel, October 20, 2023. Novartis will present late-breaking results from a prespecified exploratory subgroup analysis of invasive disease-free survival (iDFS) from the pivotal Phase III NATALEE trial at the European Society for Medical Oncology (ESMO) Congress 2023. After 27.7 months of follow-up, the iDFS benefit with Kisqal (ribociclib) plus endocrine therapy (ET) was consistent across key prespecified subgroups, compared to ET alone, in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) (see table below)1.

巴塞尔，2023年10月20日。诺华将在2023年欧洲医学肿瘤学会（ESMO）大会的关键性III期NATALEE试验中提出预先指定的无创性无病生存（iDFS）探索性亚组分析的最新成果。经过27.7个月的随访，与单独使用ET相比，在II期和III期激素受体阳性/人表皮生长患者中，使用Kisqal（ribociclib）加内分泌治疗（ET）的iDFS益处在关键预先指定的亚组中是一致的。因子受体2阴性（HR+/HER2-）早期乳腺癌（EBC）（见下表）1。

Results were also consistent with those in the overall trial population, reinforcing that the benefit was not driven by a specific patient subgroup1,2.“Subgroup analyses provide a more comprehensive picture of clinical benefit for patients and are critical to guiding treatment decisions, as they help indicate how different breast cancer subgroups might respond to treatment,” said Aditya Bardia, M.D., Attending Physician, Medical Oncology, Mass General Cancer Center and Associate Professor, Medicine, Harvard Medical School and NATALEE trial investigator.

结果也与整体试验人群一致，强调这种益处不是由特定的患者亚组驱动的。“亚组分析为患者提供了更全面的临床益处图，对于指导治疗决策至关重要，因为它们有助于表明不同的乳腺癌亚组可能对治疗有何反应，”医学博士Aditya Bardia说，主治医师，肿瘤内科，Mass General Cancer Center和哈佛医学院医学副教授和NATALEE试验研究员。

“Given the outcomes of patients treated with endocrine therapy alone, this analysis outlines the potential benefit of adding ribociclib to endocrine therapy to reduce the risk of recurrence. These data provide important insight into how we think about residual risk in this population and make adjuvant treatment decisions for patients with localized breast cancer.”“Despite endocrine therapy, cancer recurrence remains unpredictable, and too many patients diagnosed with stage II or III HR+/HER2- early breast cancer experience their cancer coming back.

“鉴于单独使用内分泌治疗的患者的结果，本分析概述了将ribociclib加入内分泌治疗以降低复发风险的潜在益处。这些数据为我们如何考虑该人群的残余风险并进行辅助治疗提供了重要见解局部乳腺癌患者的决策。“尽管内分泌治疗，癌症复发仍然是不可预测的，太多被诊断为II期或III期HR+/HER2-早期乳腺癌的患者经历了癌症的复发。

This analysis further reinforces the potential of ribociclib to address the.

这一分析进一步加强了ribociclib解决这一问题的潜力。