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Indications:1,2
- KISQALI® (ribociclib) is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy
- In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist
KISQALI is not recommended to be used in combination with tamoxifen.
KISQALI + ET* has maintained QoL relative to placebo + ET in HR+/HER2− aBC patients, regardless of menopausal status based on global health status and EORTC QLQ-C30 scores.3,4
In a match-adjusted indirect comparison (MAIC), KISQALI + AI was associated with better time to sustained deterioration in 4 of the symptom scale domains (diarrhoea, fatigue, appetite loss and arm symptoms) for 1L postmenopausal patients with HR+/HER2− aBC compared to abemaciclib + AI†5
Maintaining QoL is one of the most important considerations for patients with cancer.6 Below are the key QoL results across three Phase III studies with KISQALI:6–8
| MONALEESA-2: KISQALI + AI vs placebo + AI in 1L postmenopausal patients with HR+/HER2− aBC |
MAINTAINED vs placebo + AI |
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| MONALEESA-7: KISQALI + AI vs placebo + AI in pre-/perimenopausal patients |
IMPROVED vs placebo + AI The full population included KISQALI + AI or tamoxifen. HRQoL (median TTD ≥10%) in the ITT population was higher with KISQALI + AI or tamoxifen than placebo + AI: 35.8 months vs 23.3 months, respectively (HR=0.67; 95% CI: 0.52–0.86) (secondary endpoint; no p-value specified)6 |
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| MONALEESA-3: KISQALI + fulvestrant vs placebo + fulvestrant in 1L/2L postmenopausal patients with HR+/HER2− aBC |
MAINTAINED vs placebo + fulvestrant |
|
Measuring quality of life
The European Organisation for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire (QLQ)-C30 is a questionnaire used to measure the quality of life of cancer patients by assessing the impact on physical, psychological and social functions.8
MAIC of symptom-related QoL outcomes between KISQALI and abemaciclib for 1L postmenopausal patients
KISQALI + ET* is the only CDK4/6i that has demonstrated statistically significant OS benefit in HR+/HER– aBC across three Phase III trials9–11
KISQALI + AI has the highest clinical ESMO-MCBS rating of any CDK4/6i +AI used in 1L postmenopausal patients with HR+/HER2− aBC12–15
Study designs
MONALEESA-2: Phase III trial of KISQALI + letrozole (n=334) vs placebo + letrozole (n=334) in postmenopausal patients with HR+/HER2– aBC. The primary endpoint was locally assessed PFS. In the primary and updated analyses, PFS was significantly longer with KISQALI + letrozole than with placebo + letrozole (median in updated analysis: 25.3 months vs 16.0 months; HR for disease progression or death 0.57 [95% CI: 0.46–0.70]; P<0.001).9
MONALEESA-3: Phase III trial of KISQALI + fulvestrant (n=484) vs placebo + fulvestrant (n=242) in postmenopausal patients with HR+/HER2– aBC who were treatment naive or had received up to 1 line of prior ET in the advanced setting. The primary endpoint was locally assessed PFS. KISQALI + fulvestrant showed a significant benefit in PFS versus placebo + fulvestrant with a mPFS of 20.5 versus 12.8 months (HR 0.59 [95% CI: 0.48–0.73]; P<0.001]. OS was a secondary endpoint.10
MONALEESA-7: Phase III trial of KISQALI + ET* (n=335) vs placebo + ET (n=337) in pre- and perimenopausal patients with HR+/HER2– aBC. The primary endpoint was investigator-assessed PFS. KISQALI was associated with a significant improvement in PFS, with a median of 23.8 vs 13.0 months with placebo (HR 0.55 [95% CI: 0.44–0.69]; P<0.001]. The key secondary endpoint was OS.11
*KISQALI is not recommended to be used in combination with tamoxifen.1,2
†Please note, no head-to-head studies are available between KISQALI and abemaciclib. Results should be interpreted with caution.
1L, first-line; 2L, second-line; aBC, advanced breast cancer; ABE, abemaciclib; AE, adverse event; AI, aromatase inhibitor; BPI-SF, brief pain inventory (short form); CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CI, confidence interval; ET, endocrine therapy; EORTC, European Organisation for Research and Treatment of Cancer; EOT, end of treatment; ESS, effective sample size; HER2−, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; HRQoL, health-related quality of life; ITT, intention-to-treat; LET, letrozole; LHRH, luteinising hormone-releasing hormone; MAIC, match-adjusted indirect comparison; ML-2, MONALEESA-2; ML-3, MONALEESA-3; ML-7, MONALEESA-7; MON-3, MONARCH 3; mPFS, median progression-free survival; OS, overall survival; PBO, placebo; PFS, progression-free survival; PRO, patient-reported outcome; QLQ-BR23, breast cancer-specific quality of life questionnaire; QLQ-C30, core quality of life questionnaire; QoL, quality of life; R, randomisation; TTD, time-to-deterioration; TTDS, time to sustained deterioration; tx, treatment.
References
- KISQALI® (ribociclib) Great Britain Summary of Product Characteristics.
- KISQALI® (ribociclib) Northern Ireland Summary of Product Characteristics.
- Fasching PA, et al. Annal Oncol 2021;32(2):S60.
- Fasching PA, et al. Oral presentation. European Society for Medical Oncology Breast Cancer Congress; 5–8 May 2021, virtual.
- Rugo HS, et al. Poster 1015. American Society of Clinical Oncology, 3–7 June 2022.
- Harbeck N, et al. Ther Adv Med Oncol 2020;12:1758835920943065.
- Verma S, et al. Breast Cancer Res Treat 2018;170(3):535–545.
- Fasching PA, et al. Breast 2020;54:148–154.
- Hortobagyi GN et al. N Engl J Med 2022;386:942-950.
- Slamon DJ, et al. Ann Oncol 2021;32(8):1015–1024.
- Lu YS, et al. Clin Cancer Res 2022;28(5):851–859.
- European Society for Medical Oncology. ESMO-MCBS scorecards. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards [Accessed February 2024].
- European Society for Medical Oncology. Ribociclib and letrozole. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/es... [Accessed Accessed February 2024].
- European Society for Medical Oncology. Abemaciclib and aromatase inhibitor. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/es... [Accessed Accessed February 2024].
- European Society for Medical Oncology. Palbociclib and letrozole. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/es... [Accessed Accessed February 2024].