OVERALL SURVIVAL

Over 5.5 years median overall survival for 1L postmenopausal patients with fulvestrant

At a median follow-up of 71 months

Hazard ratio is based on unstratified Cox model.²

• Results from the 71-month analysis were not prespecified and were observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error

Statistically significant improvement in overall survival in the 1L/2L ITT population^3,4:

• At a median follow-up of 39 months, mOS with KISQALI + fulvestrant was not reached (95% CI: 42.5-NR) vs 40.0 months with placebo + fulvestrant (95% CI: 37.0-NR); P=0.00455; HR=0.724 (95% CI: 0.568-0.924)

TIME TO CHEMOTHERAPY

Median time to chemotherapy delayed 4 years

At a median follow-up of 56 months

Hazard ratio is based on stratified Cox model.³

• 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-3 was a randomized, double-blind, placebo-controlled, phase III study of KISQALI + fulvestrant (n=484) vs placebo + fulvestrant (n=242) for the treatment of postmenopausal patients with HR+/HER2- mBC who received no or only 1 line of prior ET for advanced disease. OS was a secondary end point; PFS was the primary end point.^4,6