3-YEAR iDFS

25% reduction in the risk of recurrence in patients with stage II/III HR+/HER2- eBC

NATALEE: KISQALI + AI vs AI alone

At a median follow-up of 33.3 months

Hazard ratio is based on stratified Cox model.²

iDFS was defined as the time from randomization to the date of the first event of local invasive breast cancer recurrence, regional invasive recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin), or death (any cause).¹

• At 3 years, the absolute difference in iDFS was 3.1%¹

• At the time of data cutoff, only 8.9% of patients receiving KISQALI + AI had experienced an iDFS event vs 11.1% of patients treated with AI alone¹

• A statistically significant reduction in risk was achieved despite the greater challenge of showing clinical benefit in a broad range of patients^1,3

4-YEAR iDFS

The iDFS benefit increased over time with KISQALI—beyond the 3-year treatment period

NATALEE: KISQALI + AI vs AI alone

At a median follow-up of 44 months

Hazard ratio is based on stratified Cox model.²

• At 4 years, the absolute difference in iDFS was 4.9%⁴

• At the time of data cutoff, only 10.3% of patients receiving KISQALI + AI had experienced an iDFS event vs 13.3% of patients treated with AI alone⁴

• 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.¹