Abemaciclib in combination with endocrine therapy for East Asian patients with HR+, HER2− advanced breast cancer: MONARCH 2 & 3 trials

Abstract

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The impact of race and ethnicity in breast cancer—disparities and implications for precision oncology

“…In the post hoc analysis of MONARCH2 (fulvestrant ± abemaciclib) and MONARCH3 (nonsteroidal aromatase inhibitor ± abemaciclib), the efficacy of abemaciclib in East Asians was consistent with the ITT populations [ 75 ]. In the MONARCH2 trial, East Asian patients who were treated with fulvestrant plus abemaciclib had a higher incidence of neutropenia (all grade, 67.8% vs. 35.3%; grade ≥ 3, 44.5% vs. 17.6%) and ALT elevation (all grade, 23.3% vs. 8.5%; data not reported for grade ≥ 3) compared to non-East Asian ones [ 75 ]. Diarrhea was frequently found in both East Asians and non-East Asians (all grade, 90.4% vs. 84.4%; grade ≥ 3, 14.4% vs. 12.9%).…”

“…In the MONALEESA-2 (letrozole ± ribociclib), MONALEESA-3 (fulvestrant ± ribociclib), and MONALEESA-7 (nonsteroidal aromatase inhibitor ± ribociclib) trials, dose reduction in Asians were done in 57% (50% in non-Asians), 57% (36% in non-Asians), and 45% (32% in non-Asians), respectively [ 77 ]. Dose reduction rates of abemaciclib in East Asians were 51.4% in the MONARCH2 trial (42.9% in the ITT) and 46.1% in the MONARCH3 trial (43.4% in the ITT) [ 75 ]. In the PALOMA-2 and PALOMA-3 trials, Asians had higher incidence of dose reduction (56.9% vs. 32.5% and 52% vs. 29%, respectively) [ 73 , 74 ].…”

A eficácia dos novos tratamentos de hormonioterapia na sobrevida livre de progressão de pacientes com câncer de mama metastático RH+/HER2-: uma revisão sistemática

“…• Abemaciclibe + letrozol: este regime de tratamento foi estudado nos ensaios clínicos randomizados MONARCH 3 e MONARCH plus, que evidenciaram aumento expressivo da sobrevida livre de progressão, com média de 28,2 meses, e maior taxa de resposta objetiva quando comparado com o uso de placebo mais letrozol, 61,9% e 41,8% respectivamente, como primeira linha de tratamento para o câncer de mama metastático RH+/HER2-. (Goetz et al, 2017;Johnston et al, 2019;Toi et al, 2021;Zhang et al, 2020).…”

“…Os ensaios clínicos MONARCH 2 e MONARCH plus apresentaram sobrevida livre de progressão média de 16,5 meses (95% IC 11,5-21,2), notando-se maior benefício dentre o subgrupo de mulheres na pré-menopausa, cuja SLP média foi de 28,6 meses. A análise da sobrevida global na população do MONARCH 2, demonstrou aumento de 9,4 meses, com SG média de 46,7 meses no braço abemaciclibe e 37,3 para o placebo (Neven et al, 2021;Sledge et al, 2020;Toi et al, 2021;Zhang et al, 2020).…”

Advances of Benzimidazole Derivatives as Anticancer Agents: Bench to Bedside

“…Abemaciclib (4) is chemically N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzimidazol-6-yl) Abemaciclib is commercially available by the name of Verzenio, developed by Eli Lilly as cyclin dependent kinase-4 (CDK4) and CDK6 inhibitor [41]. Furthermore, Abemaciclib is currently in various phase of clinical development as monotherapy or in combination therapy for treatment of various types of cancer and mutated forms [42,43].…”