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Small-Molecule Targeted Therapies
Published in David E. Thurston, Ilona Pysz, Chemistry and Pharmacology of Anticancer Drugs, 2021
Used in combination with ALK or MEK inhibitors, ribociclib has a synergistic effect resulting in improved responses, most likely due to the “crosstalk” between signaling pathways. In tumor cells, blocking one signaling pathway can often be compensated for by activation of other survival pathways. Therefore, blocking two or more pathways simultaneously reduces the ability of tumor cells to compensate in this manner, leading to an improved antitumor response and sometimes reduced resistance.
Hormone Receptors and Endocrine Therapy in Breast Cancer
Published in Sherry X. Yang, Janet E. Dancey, Handbook of Therapeutic Biomarkers in Cancer, 2021
Sherry X. Yang, Nancy E. Davidson
Encouraged with the results in the metastatic setting, a CDK inhibitor in combination with endocrine therapy is currently studied in adjuvant and neoadjuvant settings. Palbociclib collaborative adjuvant study is a randomized phase III trial of palbociclib with adjuvant endocrine therapy compared to endocrine therapy alone for HR+/HER2-early breast cancer (PALLAS; NCT02513394 at clinicaltrials.gov). Ribociclib plus adjuvant endocrine therapy is being tested in a phase III, randomized, double-blind, placebo-controlled clinical trial in patients with HR+, HER2-, and high-risk breast cancer (EarLEE-1; NCT03078751). MonarchE is a randomized, open-label, phase III study of abemaciclib in combination with standard adjuvant endocrine therapy versus endocrine therapy alone in patients with high risk, node-positive, early stage, HR+/HER2-breast cancer (NCT03155997). However, in a recent preplanned interim analysis, the PALLAS trial did not demonstrate a significant improvement in the primary endpoint endpoint of invasive disease-free survival.
Atypical Teratoid / Rhabdoid Tumors – AT/RT
Published in David A. Walker, Giorgio Perilongo, Roger E. Taylor, Ian F. Pollack, Brain and Spinal Tumors of Childhood, 2020
Michael C. Frühwald, Jaclyn A. Biegel, Susan N. Chi
A phase I trial of the cell cycle CDK4/6 inhibitor ribociclib (NCT017747876) in rhabdoid tumors, neuroblastomas, and other CDK4-amplified malignancies demonstrated tolerable safety and favorable pharmacokinetics in children. Fifteen patients with rhabdoid tumor (n = 13 AT/RT, n = 2 eMRT) received ribociclib orally (3 weeks on/1 week off). The maximum tolerated dose (470 mg/m2) and recommended phase II dose (350 mg/m2) were equal to those in adults. Two patients with AT/RT achieved prolonged disease stabilization. The majority of adverse events were hematologic in nature.113 Further investigations of ribociclib in combination with topotecan and temozolomide (arm A), and with everolimus (arm B) in children with refractory or recurrent malignancies are ongoing (NCT02813135). Currently, a phase I study of the selective CDK4/6 inhibitor abemaciclib (LY2835219) is specifically recruiting patients with newly diagnosed diffuse intrinsic pontine glioma and children with recurrent and refractory solid tumors, including rhabdoid tumors (NCT02644460).
Cost-effectiveness of ribociclib versus palbociclib in combination with an aromatase inhibitor as first-line treatment of postmenopausal women with HR+/HER2− advanced breast cancer: analysis based on final OS results of MONALEESA-2 and PALOMA-2
Published in Journal of Medical Economics, 2023
David Cameron, Vikash Kumar Sharma, Chandroday Biswas, Cathy Clarke, David Chandiwana, Purnima Pathak
Ribociclib and palbociclib are both CDK4/6 inhibitors that have demonstrated clinical efficacy in separate randomized clinical trials10–15, and are licensed for use in patients with HR+/HER2− breast cancer16,17. Ribociclib and palbociclib are both administered orally, with licensed doses of 600 mg and 125 mg, respectively16,17. Both drugs are administered for 21 consecutive days followed by 7 days off treatment, in combination with an aromatase inhibitor16,17 or fulvestrant18,19. The cost-effectiveness of ribociclib plus letrozole versus palbociclib plus letrozole has been previously evaluated using clinical data from the MONALEESA-2, and PALOMA-1 and PALOMA-2 studies, for ribociclib and palbociclib, respectively20. Since this prior analysis, more mature, longer-term progression-free survival (PFS) and overall survival (OS) data have been collected for both CDK4/6 inhibitors. It should be noted that another CDK4/6 inhibitor, abemaciclib, is also licensed for use in patients with HR+/HER2− breast cancer21, and a cost-effectiveness analysis of ribociclib versus abemaciclib has been conducted separately22.
Review of cyclin-dependent kinase 4/6 inhibitors in the treatment of advanced or metastatic breast cancer
Published in Journal of Drug Assessment, 2021
Lakyn Husinka, Pamela H. Koerner, Rick T. Miller, William Trombatt
Adherence rates related to oncolytic agents is a challenge given the various types of cancers treated with oncolytic agents, the variable mechanisms of actions of oncolytic agents, the variations in administration and dosing, and the difficulty in measuring dose adjustments or held doses. Abemaciclib which is dosed continuously twice daily, no rest periods per cycle, had consistent adherence rates across all patient subgroups. Palbociclib and ribociclib both consist of dosing that includes three weeks of therapy followed by a week without medication. Patients on these medications experienced high adherence rates in the monotherapy and combination with hormone therapy subgroups. However, these rates decreased in the subgroups that included another oncolytic, potentially due to conflicting or varying dosing regimens being a challenge for some patients.
Comparison of healthcare resource utilization and costs of patients with HR+/HER2- advanced breast cancer treated with ribociclib versus other CDK4/6 inhibitors
Published in Journal of Medical Economics, 2021
Rebecca Burne, Sanjeev Balu, Annie Guérin, Rebecca Bungay, Roxana Sin, Mary Lisha Paul
Total healthcare costs were significantly lower in the reweighted ribociclib cohort compared to the abemaciclib cohort during the study period (cost difference: –$5,452, p = .01). Specifically, the ribociclib cohort had significantly lower medical costs (cost difference: –$3,916, p = .05) and total pharmacy costs (cost difference: –$1,536, p = .01). With regards to individual medical cost components, the ribociclib cohort showed significantly lower OP costs compared to the abemaciclib cohort (cost difference: –$4,134, p < .01); however, IP costs (cost difference: –$255, p = .88) and ER costs (cost difference: $450, p = .14) did not differ significantly between the two reweighted patient cohorts. The difference in total pharmacy costs between cohorts was driven by the lower costs of CDK4/6 inhibitors for the ribociclib cohort compared to the abemaciclib cohort (cost difference: –$1,417, p = .01; Figure 4).