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Efficacy

KISQALI + AI in postmenopausal patients

1L in postmenopausal patients: KISQALI + AI significantly increased mOS benefit vs AI alone. (1)

1-year increase in mOS with KISQALI + AI vs AI alone. *(1)
MONALEESA-2: mOS at median 80-month follow-up

Median overall survival in MONALEESA-2: KISQALI + AI vs AI alone
63.9 months
KISQALI + AI + goserelin
51.4 months
AI alone
12.5-month
mOS increase†

* HR 0.76; 95% CI: 0.63–0.93; p=0.008. (1)

MONALEESA-2 study design

Portrait of a smilling black postmenopausal woman representing the MONALEESA-2 breast cancer study design.

MONALEESA-2: N=668, double-blind, placebo-controlled, 1:1 randomised, multicentre, phase III trial in postmenopausal women with HR+/HER2− ABC. As 1L in advanced disease.

No prior endocrine therapy for ABC and no previous systemic chemotherapy for advanced disease. KISQALI 600 mg or placebo orally once daily (3 weeks on/1 week off) + AI (letrozole 2.5 mg continuous).

The primary endpoint was locally assessed PFS, and the key secondary endpoint was OS. Other secondary endpoints included the ORR (complete or partial response), the CBR (overall response plus stable disease lasting 24 weeks or more), safety, and QOL assessments. (2)