Experts present data
Adding to the growing body of evidence for KISQALI
Ribociclib in patients with HR+/HER2− advanced breast cancer and resistance to prior endocrine therapy in the MONALEESA-3 and -7 trials
Hurvitz SA, Lee SC, Jerusalem G, et al.
Sara Hurvitz, MD, shares highlights
Summary
- Analyses of the MONALEESA-3 and MONALEESA-7 trials examined overall survival benefits in patients with endocrine resistance—a major clinical challenge in patients with HR+ advanced breast cancer1
- ET resistance was defined as progression within the first 6 months of first-line ET for aBC while on ET or as relapse within the first 2 years of (neo)adjuvant ET1
- A 41% and 30% reduction in the risk of death was observedin premenopausal and postmenopausal patients, respectively1
- Survival benefits in the ET-resistant population were consistent with those in the overall study populations1
Results
OS in endocrine therapy–resistant patients1
KISQALI—the only CDK4/6 inhibitor with improved quality of life across 3 pivotal Phase III trials2-4
Pooled analysis of patient-reported quality of life in the MONALEESA-2, -3, and -7 trials of ribociclib plus endocrine therapy to treat hormone receptor–positive, HER2-negative advanced breast cancer
Fasching PA, Bardia A, Nusch A, et al.
Peter Fasching, MD, shares highlights
Summary
- Quality of life (QoL) was assessed for patients receiving initial treatment in MONALEESA-3, patients receiving KISQALI or placebo with an aromatase inhibitor in MONALEESA-7, and all patients in MONALEESA-22
- EORTC QLQ-C30 questionnaires were used to evaluate outcomes including global health status, pain, and emotional functioning2
- Patient-reported outcomes provide important guidance for clinical decision making. The ESMO-MCBS includes QoL impact as an important consideration for grading clinical benefit4
KISQALI + ET as first-line therapy improved quality of life in pre- and postmenopausal patients with aBC2-4
- TTD in pain and in emotional and social functioning was also delayed vs the control arm
- No marked differences in deterioration of quality of life due to fatigue and physical functioning vs the control arm
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Dose reductions with KISQALI do not compromise overall survival5
Impact of ribociclib dose reduction on overall survival in patients with HR+/HER2– advanced breast cancer in MONALEESA-3 and -7
De Laurentiis M, de la Cruz-Merino L , Hart L, et al.
Michelino De Laurentiis, MD, shares highlights
Summary
- An analysis of the MONALEESA-3 and MONALEESA-7 clinical trials assessed the impact of dose reductions with KISQALI on overall survival5
- Patients who require a dose reduction, for adverse event management or other reasons, can continue to receive survival benefits with KISQALI5
- OS benefit was maintained regardless of ribociclib dose reduction and was consistent with the overall population based on the hazard ratios derived from time-dependent Cox models6
Overall survival by dose reduction and relative dose intensity5
- Across both trials, ~41% of patients received ≥1 dose reduction5
- Relative dose intensity (RDI) was also assessed to account for reduction or interruption5
See the safety profile for KISQALI
View trial designs for MONALEESA-3 and MONALEESA-7
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Unanchored matching-adjusted indirect treatment comparison with KISQALI + ET and palbociclib + ET in first-line postmenopausal patients7
Comparative effectiveness of ribociclib plus fulvestrant versus palbociclib plus letrozole as first-line treatment of HR+/HER2− advanced breast cancer assessed by matching-adjusted indirect comparison
Fasching PA, Delea TE, Lu Y-S, et al.
Peter Fasching, MD, shares highlights
Summary
- MONALEESA-3 and PALOMA-1 are the only CDK4/6 inhibitor trials to report first-line OS results in postmenopausal patients8
- Because it is difficult to compare two separate clinical trials directly, a matching-adjusted indirect comparison (MAIC) provides an opportunity to indirectly compare them by adjusting for differences in patient populations8
- It is important to understand that these types of analyses cannot provide the same type of confirmation as a clinical trial, so these results are only meant to provide an idea of the differences between the two treatments when a clinical trial comparing the two is unavailable8
- Using an MAIC to account for differences in the patient populations, this analysis leveraged data from patients receiving first-line treatment with KISQALI + fulvestrant or placebo + fulvestrant in MONALEESA-3 and palbociclib + letrozole or placebo + letrozole in PALOMA-18
- This analysis supported the first-line use of KISQALI8
- Median OS was significantly longer with KISQALI + fulvestrant vs palbociclib + letrozole in the unweighted and weighted analyses8
- While MAIC analyses provide an estimate for differences between two trials in the absence of head-to-head clinical studies, they do not serve as a replacement for a clinical trial to confirm or refute a true difference8
Analysis Methods
- An unanchored MAIC analyzing PFS and OS was conducted using individual patient data from those receiving KISQALI + fulvestrant or placebo + fulvestrant first line in the phase III MONALEESA-3 trial and aggregated data from the phase II PALOMA-1 trial8
- To match patients in PALOMA-1, only patients with no prior ET for advanced disease and no (neo)adjuvant letrozole ≤12 months before enrollment in MONALEESA-3 were included8
- 329 patients in the KISQALI arm and 178 patients from the control arm of MONALEESA-3 were reweighted to match average baseline characteristics of 84 patients in the palbociclib arm and 81 patients from the control arm of PALOMA-18
- After weighting, patients were well balanced across characteristics8
- PFS and OS were compared using Kaplan-Meier estimators and Cox regressions8
Overall Survival for KISQALI + Fulvestrant vs Palbociclib + Letrozole
The KM curve here was based on digitized data that only reach 50.9% for the PAL + LET arm; as such, the median was not reached in this analysis and the OS for this arm may be slightly overestimated, meaning this analysis may be conservative.
Median value from published data.7
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