KISQALI + AI in 1L Postmenopausal | mBC | KISQALI® (ribociclib) | HCP

KISQALI patient portrayal.

More life for living

KISQALI—the only CDK4/6 inhibitor to achieve statistically significant overall survival in first line in combination with an AI

MONALEESA-2: KISQALI + AI in 1L postmenopausal patients

OVERALL SURVIVAL

Over 5 years median overall survival for 1L postmenopausal patients with an AI

At a median follow-up of 80 months

KM curve showing >1-year increase in median overall survival: 63.9 months mOS with KISQALI + AI (95% CI: 52.4-71.0) vs 51.4 months with placebo + AI (95% CI: 47.2-59.7); HR=0.765 (95% CI: 0.628-0.932); P=0.004.

Hazard ratio is based on stratified Cox model.²

OS benefit with KISQALI increased over time

At 6 years, the survival rate of patients receiving KISQALI + letrozole was 44% vs 32% with placebo + letrozole²

TIME TO CHEMOTHERAPY

Median time to chemotherapy delayed over 4 years

At a median follow-up of 80 months

KM curve showing median time to chemotherapy: 50.6 months with KISQALI + AI vs 38.9 months with placebo + AI (~1-year difference).

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 treatment⁴
There was no prespecified statistical procedure controlling for type 1 error

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.^1,2,5

EFFICACY
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EFFICACY
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1L=first line; AI=aromatase inhibitor; CDK=cyclin-dependent kinase; HR=hazard ratio; mBC=metastatic breast cancer; mOS=median overall survival; mTTC=median time to chemotherapy; OS=overall survival; PFS=progression-free survival.

References: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp. 2. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med. 2022;386(10):942-950. doi:10.1056/NEJMoa2114663 3. Data on file. MONALEESA-2 final overall survival analysis. Novartis Pharmaceuticals Corp; 2021. 4. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375(18):1738-1748;(protocol). doi:10.1056/NEJMoa1609709 5. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375(18):1738-1748. doi:10.1056/NEJMoa1609709