Efficacy: Quality Time | KISQALI® (ribociclib) Professional Site

For Healthcare Professionals Outside the US
KISQALI 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 luteinizing hormone‑releasing hormone (LHRH) agonist.

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The only CDK4/6 inhibitor with improved quality of life across 3 pivotal phase III trials^1-3

Quality of life

Results from a pooled quality of life analysis of patients receiving first-line therapy with KISQALI + ET in MONALEESA-2, MONALEESA-3, and MONALEESA-7¹
TTD in pain and in emotional and social functioning was also delayed vs the control arm^4,5

Time to chemotherapy delayed in pre- and postmenopausal patients

At a median follow-up of 80 months
Postmenopausal patients with an AI were kept off chemotherapy for a median of over 4 years⁶

time-to-chemo-D

At a median follow-up of 54 months
Premenopausal patients with ET were kept off chemotherapy for a median of over 4 years⁷

time-chemo1

At a median follow-up of 56 months
Postmenopausal patients with fulvestrant were kept off chemotherapy for a median of 4 years⁸

time-chemo2

Reprinted with permission from Elsevier.
Hazard ratios are based on stratified Cox models.

Time to chemotherapy was an exploratory end point in all 3 trials, TTC was defined as the time from randomization to the beginning of the first chemotherapy after discontinuing study treatment^6-8
There was no prespecified statistical procedure controlling for type 1 error

AI, aromatase inhibitor; CDK, cyclin-dependent kinase; ET, endocrine therapy; HR, hazard ratio; ITT, intent to treat; mTTC, median time to chemotherapy; TTD, time to deterioration.

Dennis Slamon, MD, PhD
University of California, Los Angeles
Los Angeles, CA
With KISQALI, now you can treat across the spectrum of pre- and postmenopausal patients for not only PFS but also OS, in first line and second line.

Peter Fasching, MD
University of Erlangen
Erlangen, Germany
Triple end point success with KISQALI: Improvements in OS, PFS, and QoL.

References: 1. Fasching P, Bardia A, Nusch A, et al. Pooled analysis of patient (pt)-reported outcomes (pros) in the MONALEESA (ml)-2, -3, and -7 trials: additional results and key subgroup findings. Presented at: ESMO Breast Cancer virtual congress; May 5-8, 2021. 2. Ibrance [Summary of Product Characteristics]. Pfizer Inc: 2018. 3. Verzenio [Summary of Product Characteristics]. Eli Lilly and Company; 2018. 4. Fasching P, Bardia A, Nusch A, et al. 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. Presented at: ESMO virtual congress; September 19-21, 2020. 5. Fasching PA, Beck JT, Chan A, et al. Ribociclib plus fulvestrant for advanced breast cancer: health-related quality-of-life analyses from the MONALEESA-3 study. Breast. 2020;54:148-154. 6. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival results from the phase III MONALEESA-2 trial of postmenopausal patients with HR+/HER2− advanced breast cancer treated with endocrine therapy ± ribociclib. Presented at: European Society of Medical Oncology; September 16-21, 2021. 7. Tripathy D, Im S-A, Colleoni M, et al. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with HR+/HER2– advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Presented at: San Antonio Breast Cancer Symposium; December 8-12, 2020; San Antonio, TX. Poster PD2-04. 8. Slamon DJ, Neven P, Chia S, et al. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol. 2021;32(8):1015-1024.