Experts present data
Adding to the growing body of evidence for KISQALI
Updated overall survival results from the phase III MONALEESA-3 trial of postmenopausal patients with HR+/HER2− advanced breast cancer treated with fulvestrant ± ribociclib
Slamon D, Neven P, Chia S, et al.
Background and methods1-3
- A statistically significant improvement in overall survival was previously demonstrated in an analysis with a median follow-up of 39 months, after which patients and investigators were unblinded, allowing patients with ongoing treatment in the placebo arm to cross over to the KISQALI arm
- OS at a median follow-up of 39 months (ITT population): Not reached with KISQALI + fulvestrant vs 40.0 months in the placebo arm (HR=0.72; 95% CI: 0.57-0.92; P=0.00455)
- Updated OS results from an ad hoc exploratory analysis of the MONALEESA-3 trial with a median follow-up of 56 months are presented below
- This 56-month analysis allows for an additional ~17 months of follow-up
Nearly 4.5 years median OS in postmenopausal patients in combination with fulvestrant1
View expert perspectives on updated OS in MONALEESA-3
Additional results from this analysis are available below
Click below to view recent findings for KISQALI in several areas
QoL and work productivity in premenopausal patients
Improvements in quality of life with KISQALI positively impact work productivity in premenopausal patients4
Correlation from work productivity loss and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire domains from the MONALEESA-7 trial of premenopausal patients with HR+/HER2− advanced breast cancer
Tripathy D, Curteis T, Hurvitz S, et al.
Background and methods4-6
- Younger patients with aBC report greater symptom severity and activity impairment, due in part to the expectation that younger patients assume more active work-related roles
- Investigators used data from employed patients in MONALEESA-7, a dedicated premenopausal trial, to explore the relationship between domains of QoL and work productivity loss (WPL)
- ~50% (n=329/672) of patients were employed during the trial
- The following patient-reported outcome tools from the trial were used in this analysis
- The EORTC QLQ-C30, a questionnaire that evaluates patient-reported outcome measures of health-related quality of life, functioning, disease symptoms, and treatment-related side effects
- EORTC QLQ-BR23, a quality of life questionnaire specific to breast cancer
- WPAI:GH, a work productivity/productivity loss questionnaire
Results4
- Increases in QoL were associated with increases in work productivity
- Conversely, greater work productivity loss was associated with
- Higher levels of fatigue and pain
- Lower levels of overall quality of life
- Decreased social, emotional, physical, and role functioning
Impact of QoL Domains on Work Productivity Loss4
Pooled QoL findings by domain and subgroups
KISQALI delayed deterioration in quality of life across several patient subgroups and EORTC domains, including diarrhea7
Pooled analysis of patient-reported outcomes in the MONALEESA-2, -3, and -7 trials: additional results and key subgroup findings
Fasching PA, Bardia A, Nusch A, et al.
Background and methods7,8
- This analysis presents findings on individual dimensions of QoL across the MONALEESA trials
- A recent pooled analysis of the MONALEESA trials demonstrated that KISQALI + ET improved quality of life in pre- and postmenopausal patients
- Patient-reported outcomes were collected using the EORTC questionnaires
- 1528 first-line patients were included
- Time to deterioration (TTD) for the KISQALI and control arms was assessed for nausea and vomiting, diarrhea, and anxiety or depression, as well as in subgroups of patients by age, race, and molecular subtype
Results
KISQALI delayed deterioration in QoL across several subgroups and EORTC domains7
Survival outcomes in premenopausal patients by age
KISQALI substantially improves overall survival in younger premenopausal PATIENTS—those most at need for unprecedented outcomes9
Overall survival results by age subgroup from the phase III MONALEESA-7 trial of premenopausal patients with HR+/HER2− advanced breast cancer treated with ribociclib ± endocrine therapy
Lu Y-S, El-Saghir N, Hurvitz S, et al.
Yen-Shen Lu, MD shares highlights
Background and methods9-12
- Premenopausal patients with aBC face distinct clinical challenges
- Younger patients (≤40 years old) in particular, have an increased risk of death
- KISQALI + ET has previously demonstrated a statistically significant and sustained survival benefit in a trial dedicated to premenopausal patients
- OS at a median follow-up of 35 months (ITT population): Not reached with KISQALI + AI/tamoxifen vs 40.9 months in the placebo arm (HR=0.71; 95% CI: 0.54-0.95; P=0.00973)
- Nearly 5 years mOS demonstrated in an ad hoc exploratory analysis with a median follow-up of 54 months
- 58.7 months with KISQALI + AI vs 47.7 months in the placebo arm (HR=0.798; 95% CI: 0.615-1.035)
- This exploratory analysis characterizes overall survival with KISQALI + AI in patients <40 and ≥40 years of age
- ~29% of patients were <40 years old
- ~71% of patients were ≥40 years old
- Median follow-up time was 54 months
Results
KISQALI prolonged survival in premenopausal patients, regardless of age range9
- Compelling 34% reduction in risk of death in patients younger than 40 years old, those at greatest risk for mortality
KISQALI improved post-progression outcomes, regardless of age, in the ITT population9
