Efficacy

Efficacy across trials

KISQALI is the only CDK4/6i with statistically significant 1L mOS benefit across 3 phase III trials. *(1–4)

Provide KISQALI to a broad range of your patients with HR+/HER2– ABC †(5)

OS was a secondary endpoint in the MONALEESA studies.
* MONALEESA-2: At median 80-month follow-up, KISQALI + AI achieved mOS of 63.9 months vs 51.4 months with placebo + AI (HR 0.76; 95% CI: 0.63–0.93; p=0.008).

MONALEESA-3: At median 71-month follow-up, KISQALI + fulvestrant achieved mOS of 67.6 months vs 51.8 months with placebo + fulvestrant (HR 0.67; 95% CI: 0.50–0.9).

MONALEESA-7: At median 54-month follow-up, KISQALI + AI achieved mOS of 58.7 months vs 47.7 months with placebo + AI (HR 0.8; 95% CI: 0.62–1.04). OS benefit in the prespecified 2nd interim analysis: HR 0.70; 95% CI, 0.50–0.98.(c)

vs AI in the NATALEE study and ET in the MONALEESA studies. Consistent results across a broad range of HR+/HER2– eligible patients with statistically significant improvements in iDFS (EBC), PFS and OS (ABC).(5) KISQALI should not be co-administered with tamoxifen.(5)

Pooled analysis of 1124 patients with visceral metastases (including liver metastases or ≥3 disease sites) from across the MONALEESA trials, 714 of these patients received 1L treatment and are included here (395 patients received KISQALI + ET). These data are exploratory and hypothesis-generating only. HR 0.79; 95% CI: 0.65–0.97, p=0.023. (4)

By Novartis AG
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