Novartis: Adjuvant Kisqali Shows OS Benefit in HR+/HER2- Early Breast Cancer

Adding ribociclib (Kisqali, Novartis) to endocrine therapy reduced the risk of death compared with endocrine therapy alone in patients with hormone receptor–positive, HER2-negative (HR+/HER2−) stage II or III early breast cancer at high risk of recurrence, according to 6-year results from the phase 3 NATALEE trial. Novartis announced the findings in a press release ahead of their presentation at the European Society for Medical Oncology Annual Meeting 2026.

The global, randomized, open-label trial randomized 5,101 adults, including patients with high-risk node-negative or node-positive disease. Patients in both groups received a nonsteroidal aromatase inhibitor (anastrozole or letrozole), plus goserelin when applicable. The primary endpoint is invasive disease-free survival (iDFS).

In the 6-year analysis, the hazard ratio for overall survival (OS) was 0.809 (95% CI, 0.661-0.989), a 19.1% relative reduction in the risk of death. The absolute OS difference was 2.1 percentage points, up from 1.2 points at 5 years. For iDFS, the hazard ratio was 0.741, and the absolute benefit grew from 4.1 percentage points at 5 years to 5.3 points at 6 years.

Breast cancer–specific survival, distant disease-free survival and distant recurrence-free survival also favored the combination (hazard ratios, 0.709, 0.744 and 0.738, respectively). Patients had been off ribociclib for a median of 38 months at the time of analysis. Novartis reported that the safety profile was consistent with previous analyses, with no new safety signals. Secondary primary malignancies occurred in 3.0% of the ribociclib group and 3.3% of the endocrine therapy group.

According to Novartis, ribociclib is indicated in the US in combination with an aromatase inhibitor as adjuvant treatment for adults with HR+/HER2− stage II and III early breast cancer at high risk of recurrence.

Source: Novartis Pharma AG. Kisqali shows clinically meaningful overall survival in broadest HR+/HER2- early breast cancer population at high risk of recurrence. Press release. Novartis Pharma AG; October 23, 2026. Accessed October 25, 2026.