OVERALL SURVIVAL

Nearly 5 years median overall survival for 1L premenopausal patients

At a median follow-up of 54 months

Hazard ratio is based on unstratified Cox model.²

• Results from the 54-month analysis were not prespecified and were observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error

At a median follow-up of 35 months,
Statistical significance was established for OS in the 1L ITT population; P=0.00973 (HR=0.71 [95% CI: 0.54-0.95]).³

• In the subgroup of patients who received tamoxifen, an increased risk for QT prolongation was observed. KISQALI is not indicated for concomitant use with tamoxifen⁴

TIME TO CHEMOTHERAPY

Median time to chemotherapy delayed over 4 years

At a median follow-up of 54 months

• Time to chemotherapy was an exploratory end point and was defined as the time from randomization to the beginning of the first chemotherapy after discontinuing study treatment³

• There was no prespecified statistical procedure controlling for type 1 error

Study design: MONALEESA-7 was a randomized, double-blind, placebo-controlled, phase III study of KISQALI + ET (NSAI or tamoxifen) + goserelin (n=335) vs placebo + ET (NSAI or tamoxifen) + goserelin (n=337) (ITT) in premenopausal patients with HR+/HER2- mBC who received no prior ET for advanced disease. KISQALI is not indicated for concomitant use with tamoxifen. Efficacy results are from a prespecified subgroup analysis of 495 patients who received KISQALI (n=248) or placebo (n=247) with an NSAI + goserelin and were not powered to show statistical significance. OS was a secondary end point; PFS was the primary end point.^4,5