Patients were stratified by the presence of liver and/or lung metastases, prior chemotherapy for advanced disease, and endocrine combination partner. The primary end point was PFS using RECIST v1.1; secondary end points included OS, ORR, QoL, and safety. The efficacy results presented are from a prespecified subgroup analysis of 495 patients who had received KISQALI or placebo with an AI plus an LHRH agonist. A separate cohort of 179 patients was randomized to receive KISQALI 600 mg once daily (3 weeks on, 1 week off) in combination with tamoxifen 20 mg (once daily on a continuous basis) plus an LHRH agonist. KISQALI is not indicated for concomitant use with tamoxifen.1-3
aBC, advanced breast cancer; ET, endocrine therapy; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; QoL, quality of life; RECIST, Response Evaluation Criteria In Solid Tumors.
References: 1. KISQALI [Summary of Product Characteristics]. Novartis Pharma AG; 2019. 2. Tripathy D, Im S-A, Colleoni M, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2019;19(7):904-915. 3. Harbeck N, Franke F, Villanueva-Vazquez R, et al. Health-related quality of life in premenopausal women with hormone-receptor-positive, HER2- negative advanced breast cancer treated with ribociclib plus endocrine therapy: results from a phase III randomized clinical trial (MONALEESA-7). Ther Adv Med Oncol. 2020;12:1758835920943065.