New life-changing survival data for women with HR+/HER2- metastatic breast cancer

Novartis is pleased to share new study results for KISQALI® (ribociclib), which now include overall survival (OS) data that no other CDK 4/6 inhibitor has yet reported: statistically significant OS in in first-line postmenopausal patients with an aromatase inhibitor.1

MONALEESA-2 was a dedicated first-line trial of KISQALI + letrozole vs placebo + letrozole in postmenopausal patients with HR+/HER2- mBC (N=668)2,3

  • OS: At a median follow-up of 80 months, mOS was 63.9 months with KISQALI + letrozole (95% CI: 52.4-71.0) vs 51.4 months with letrozole (95% CI: 47.2-59.7); HR=0.765 (95% CI: 0.628-0.932); P=0.0041
  • PFS (primary end point): At a median follow-up of 15 months, mPFS was not reached with KISQALI + letrozole (95% CI: 19.3-NR) vs 14.7 months with placebo + letrozole (95% CI: 13.0-16.5); HR=0.556 (95% CI: 0.429-0.720); P<0.00012,3

Study design: MONALEESA-2 was a randomized, double-blind, placebo-controlled phase III study of KISQALI + letrozole (n=334) vs placebo + letrozole (n=334) in postmenopausal patients with HR+/HER2- mBC who received no prior therapy for advanced disease. OS was a secondary end point; PFS was the primary end point.2,3

KISQALI is now the only CDK4/6 inhibitor with statistically significant overall survival proven across 3 phase III trials.1,4,5

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