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Poster Discussion - Breast cancer, metastatic

1076 - MONARCHplus: A Phase 3 Trial of Abemaciclib plus Nonsteroidal Aromatase Inhibitor (NSAI) or Fulvestrant (F) for Women with HR+/HER2- Advanced Breast Cancer (ABC)


29 Sep 2019


Poster Discussion - Breast cancer, metastatic


Zefei Jiang


Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394


Z. Jiang1, X. Hu2, Q. Zhang3, T. Sun4, Y. Yin5, H. Li6, R. Costa7, M. Yan8, C. Oppermann9, Z. Tong10, Y. Liu11, Y. Zhang12, Y. Cheng13, Q. Ouyang14, X. Chen15, N. Liao16, X. Wu17, X. Wang18, R. Han19, Y. Lu20

Author affiliations

  • 1 Department Of Breast Cancer, The Fifth Medical Center of Chinese PLA General Hospital, 100071 - Beijing/CN
  • 2 Department Of Medical Oncology, Fudan University Shanghai Cancer Center, 200032 - Shanghai/CN
  • 3 Department Of Medical Oncology, Harbin Medical University Cancer Hospital, 1150081 - Harbin/CN
  • 4 Department Of Medical Oncology, Liaoning Cancer Hospital, Shenyang/CN
  • 5 Department Of Oncology, Jiangsu Province Hospital, Nanjing/CN
  • 6 Department Of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing/CN
  • 7 Oncologia Clínica, Instituto do Cancer do Estado de São Paulo -ICESP, São Paulo/BR
  • 8 Department Of Breast Cancer, The affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou/CN
  • 9 Centro De Pesquisa Clínica De Oncologia E Hematologia, Hospital Mãe de Deus/AESC, Porto Alegre/BR
  • 10 Department Of Breast Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin/CN
  • 11 Department Of Medical Oncology, The First Hospital of China Medical University, Shenyang/CN
  • 12 Department Of Oncology, Second Affiliated Hospital of Dalian Medical University, Dalian/CN
  • 13 Department Of Medical Thoracic Oncology, Jilin Provincial Cancer Hospital, Changchun/CN
  • 14 Department Of Breast Cancer Medical Oncology, Hunan Cancer Hospital, Changsha/CN
  • 15 Department Of Medical Oncology, Fuzhou General Hospital of Nanjing Military Command, Fuzhou/CN
  • 16 Department Of Breast, Guangdong General Hospital, Guangzhou/CN
  • 17 Department Of Breast, Hubei Cancer Hospital, Wuhan/CN
  • 18 Department Of Breast Medical Oncology, Zhejiang Cancer Hospital, Hangzhou/CN
  • 19 Oncology, Eli Lilly and Company, Shanghai/CN
  • 20 Global Statistical Sciences - Oncology, Eli Lilly and Company, Indianapolis/US


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Abstract 1076


Abemaciclib is an oral, selective CDK4 & 6 inhibitor dosed on a continuous schedule and approved in combination with endocrine therapy (ET) for HR+/HER2- ABC patients (pts) outside of China in more than 50 countries.

MONARCHplus evaluated the efficacy and safety of abemaciclib plus ET in predominantly Chinese pts with HR+/HER2- ABC.


MONARCHplus was a randomized-controlled, double-blind phase III trial for postmenopausal women with endocrine sensitive (Cohort A) or endocrine resistant (Cohort B) HR+/HER2- ABC. In Cohort A, pts received abemaciclib (150 mg Q12h)/ placebo (P) + NSAI (anatrozole or letrozole) as first-line ET. In Cohort B, pts received abemaciclib/P + F following progression to ET. Both cohorts were randomized at a 2:1 ratio. The primary objective was PFS in Cohort A with a key secondary objective of PFS in Cohort B. The trial was powered for Cohort A to 80% at 1-sided α=.025 assuming a hazard ratio (HR) of 0.626 in favor of abemaciclib + NSAI, with analyses at 119 and 170 PFS events.


At the pre-specified interim, 119 PFS events were observed in Cohort A (n = 306) and 82 events in Cohort B (n = 157). Abemaciclib +NSAI and abemaciclib + F statistically and significantly improved PFS and ORR (see Table). PFS benefit was consistent within all stratification factors and pre-specified sensitivity analyses. The safety profile for both abemaciclib arms was consistent with previous reports for abemaciclib plus ET and included neutropenia, diarrhea, leukopenia, and anemia as the most frequent adverse events (AEs).Table: LBA25

Summary of PFS and ORR in ITT population

Cohort ACohort B
Abemaciclib + NSAI (n = 207)P + NSAI (n = 99)Abemaciclib + F (n = 104)P + F (n = 53)
Median PFS(months)NR*14.7311.475.59
HR (95% CI)0.499 (0.346, 0.719)0.376 (0.240, 0.588)
ORR (%)56.030.338.57.5

NR= not reached.


Abemaciclib in combination with NSAI or fulvestrant provided a statistically significant and clinically meaningful improvement in PFS in predominantly Chinese postmenopausal women with HR+/HER2- ABC with no new safety signals observed. The MONARCHplus interim analysis demonstrated benefit consistent with the MONARCH 2 and 3 studies.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

Eli Lilly and Company.


Eli Lilly and Company.


All authors have declared no conflicts of interest.

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