Novartis reports clinically meaningful overall survival benefit for Kisqali after 6-year follow-up
Key Facts
Novartis said 6-year follow-up data for Kisqali in patients with early breast cancer showed a clinically meaningful overall survival benefit. The company reported the result in its second-quarter 2026 earnings announcement, without publishing a reduction in the risk of death or numerical survival rates in the statement. The available information therefore does not support the 19% figure cited in the initial version of the report. Novartis also did not describe the improvement as "significant," instead using the phrase "clinically meaningful benefit." The result places overall survival within the long-term follow-up of Kisqali, while quantitative measurement details were not included in the announcement.
The reference to extended follow-up comes as Kisqali is delivering commercial growth for Novartis; the drug's sales rose 43% at constant currencies in the second quarter of 2026, according to the company's statement. Over the same period, Novartis net sales grew 1% at constant currencies and 3% in U.S. dollars. These figures show that Kisqali's growth exceeded the company's overall sales growth rate during the quarter, with the drug's growth measured at constant currencies and net sales reported on two bases. The drug's performance stood out in quarterly results that combined limited net sales growth with a faster increase in Kisqali sales. The statement did not explicitly link the overall survival result to the sales growth rate.
Results from the NATALEE trial published in 2025 provide earlier clinical context that is separate from the subsequently reported overall survival result. In the 5-year analysis, invasive disease-free survival was 85.5% among those who received Kisqali with endocrine therapy, compared with 81.0% with endocrine therapy alone. The absolute difference between the groups was 4.5 percentage points. Novartis said adding Kisqali to endocrine therapy reduced the risk of disease recurrence by 28.4% compared with endocrine therapy alone, in the analysis announced on October 17, 2025. These figures concern disease recurrence and invasive disease-free survival after 5 years; they are different measures from overall survival in the 6-year follow-up.
NATALEE was a pivotal Phase 3 trial that included patients with high-risk stage II and III HR+/HER2- early breast cancer. The trial compared Kisqali added to endocrine therapy with endocrine therapy alone. Commenting on the 5-year results, John Crown, an oncologist and trial investigator, said, "These 5-year results show that the benefit of ribociclib continues for a long time after treatment ends." He added that fear of early breast cancer returning, sometimes as advanced disease that cannot be cured, weighs on patients and their families. The comment places the persistence of benefit after treatment ends at the center of the 5-year results, without changing the nature of the measure or making it an overall survival result.
Novartis said the NATALEE trial will continue follow-up to ensure sufficient data are collected on overall survival and other long-term endpoints. The step follows the announcement of 6-year follow-up indicating a clinically meaningful overall survival benefit, without detailed figures in the statement. The company said continued data collection remains part of the trial's process for measuring long-term outcomes. The source did not specify when a subsequent update would be published or provide additional numerical details on overall survival.