---
title: "Efficacy across trials | Kisqali®"
description: "Kisqali is the only CDK4/6 inhibitor with consistent 1L mOS benefit across 3 phase III trials in HR+/HER2– aBC. Explore efficacy across trials."
canonical_url: "https://www.kisqali.com/advanced-breast-cancer/efficacy/efficacy-across-trials"
meta:
  "og:description": "Kisqali is the only CDK4/6 inhibitor with consistent 1L mOS benefit across 3 phase III trials in HR+/HER2– aBC. Explore efficacy across trials."
  "og:title": "Efficacy across trials"
---

## **Efficacy across trials**

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

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

#### **Menopausal status**

- Premenopausal
- Postmenopausal

#### **Combination partner**

- KISQALI + AI
- KISQALI + fulvestrant

#### **Visceral metastases**<sup>‡</sup>

- Liver metastases
- Multiple metastatic sites

access\_time 5-year m0S achived with KISQALI + ET<sup>(1-4)</sup>

*“Overall survival is the hardest endpoint to achieve in clinical trials. And in many respects, perhaps the most important...we’re trying to improve the survival of the patient, not just the progression-free survival...” *

**Dennis Slamon, MD, PhD**  
University of California, USA

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.<sup>(c)</sup>  
  
<sup>†</sup> *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).<sup>(5)</sup> KISQALI should not be co-administered with tamoxifen.<sup>(5)</sup>  
  
<sup>‡</sup> 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. <sup>(4)</sup>

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