Reduced risk of distant recurrence
In the NATALEE trial, KISQALI reduced the threat of recurrence with incurable metastatic disease in the broadest population of patients with stage II/III HR+/HER2- eBC.
3-YEAR DDFS
25% reduction in the risk of distant recurrence—a clinical benefit consistent with the primary end point
NATALEE: KISQALI + AI vs AI alone
![KM curve showing distant disease-free survival at 3 years: 92.9% with KISQALI + AI vs 90.2% with AI alone (25% reduction in risk of distant recurrence; HR=0.749 [95% CI: 0.623-0.900]).](https://usim.beprod.kisqali-hcp.com/sites/kisqali_hcp_com/files/styles/webp/public/styles/common_width_472/public/2024-08/kisqali-early-breast-cancer-ddfs-at-3-years-km-curve-mobile_0.png.webp?itok=z3Auz3GF)
Hazard ratio is based on stratified Cox model.2
DDFS was defined as the time from randomization to the date of the first event of distant recurrence, second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin), or death (any cause).2
At 3 years, the absolute difference in DDFS was 2.7%1
At the time of data cutoff, only 8% of patients receiving KISQALI + AI had experienced a DDFS event vs 10% of patients treated with AI alone1
4-YEAR DDFS
The DDFS benefit increased over time with KISQALI—beyond the 3-year treatment period
NATALEE: KISQALI + AI vs AI alone
![KM curve showing distant disease-free survival at 4 years: 89.4% with KISQALI + AI vs 84.9% with AI alone (29% reduction in risk of distant recurrence; HR=0.715 [95% CI: 0.604-0.847]).](https://usim.beprod.kisqali-hcp.com/sites/kisqali_hcp_com/files/styles/webp/public/styles/common_width_472/public/2024-09/kisqali-early-breast-cancer-ddfs-at-4-years-km-curve-mobile_0.png.webp?itok=dgo85HlZ)
Hazard ratio is based on stratified Cox model.2
At 4 years, the absolute difference in DDFS was 4.5%4
At the time of data cutoff, only 9.4% of patients receiving KISQALI + AI had experienced a DDFS event vs 12.2% of patients treated with AI alone3
Results from the exploratory 4-year analysis were not prespecified and were observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error
NATALEE was a randomized, multicenter, open-label, phase III study of KISQALI + letrozole or anastrozole (n=2549) vs letrozole or anastrozole (n=2552) for the adjuvant treatment of men and women with stage II/III HR+/HER2- eBC. iDFS was the primary end point; DDFS was a secondary end point. At a median follow-up of 33.3 months, with 509 iDFS events in the study (226 [8.9%] in the KISQALI arm and 283 [11.1%] in the NSAI-alone arm), iDFS at the 3-year landmark was 90.7% for KISQALI + NSAI vs 87.6% for NSAI alone (absolute difference 3.1%); there was a 25.1% relative reduction in the risk of an iDFS event; HR=0.749 (95% CI: 0.628-0.892).1,5,6