MONARCH 3: Updated time to chemotherapy and disease progression following abemaciclib plus aromatase inhibitor (AI) in HR+, HER2- advanced breast cancer (ABC)

M. Martín; S. Johnston; J. Huober; A. Di Leo; J. Sohn; V.A. Andre; H.R. Martin; M.C. Hardebeck; M.P. Goetz

doi:10.1093/annonc/mdz242.021

Submitted abstracts Breast cancer, metastatic| Volume 30, SUPPLEMENT 5, v113-v114, October 01, 2019

MONARCH 3: Updated time to chemotherapy and disease progression following abemaciclib plus aromatase inhibitor (AI) in HR+, HER2- advanced breast cancer (ABC)

M. Martín
M. Martín
Affiliations
Department Servicio de Oncologia Médica, Instituto de Investigacion Sanitaria Gregorio Marañon, Ciberonc, Geicam; Universidad Complutense, Madrid, Spain
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S. Johnston
S. Johnston
Affiliations
Breast Unit, The Royal Marsden NHS Foundation Trust, London, UK
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J. Huober
J. Huober
Affiliations
Comprehensive Cancer Center Ulm, University of Ulm, Ulm, Germany
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A. Di Leo
A. Di Leo
Affiliations
Sandro Pitigliani Medical Oncology Unit, Hospital of Prato, Istituto Toscano Tumori, Prato, Italy
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J. Sohn
J. Sohn
Affiliations
Medical Oncology Department, Yonsei University, Seoul, Republic of Korea
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V.A. Andre
V.A. Andre
Affiliations
Global Statistical Sciences, Eli Lilly and Company, Paris, France
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H.R. Martin
H.R. Martin
Affiliations
Global Medical Affairs, Eli Lilly and Company, Indianapolis, IN, USA
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M.C. Hardebeck
M.C. Hardebeck
Affiliations
Global Development, Eli Lilly and Company, Indianapolis, IN, USA
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M.P. Goetz
M.P. Goetz
Affiliations
Department of Oncology, Mayo Clinic, Rochester, MN, USA
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Open ArchiveDOI:https://doi.org/10.1093/annonc/mdz242.021

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Abstract

Background

In MONARCH 3, a randomized, double-blind, phase 3 trial; continuous dosing of abemaciclib in combination with an AI (anastrozole or letrozole) conferred significant clinical benefit to postmenopausal women with HR+, HER2- ABC. We here report data from an additional 12 months of follow-up in this trial including analysis for clinically prognostic subgroups (Di Leo et al., 2018).

Methods

From the 31 October 2018 data cutoff, exploratory intermediate efficacy parameters including time to subsequent chemotherapy ([TCT] time from randomization to first chemotherapy [CT]) and time to second disease progression ([PFS2] time from randomization to discontinuation date of first post-discontinuation treatment [PDT], or starting date of the secondPDT, or death) were assessed. TCT and PFS2 were analyzed using the Kaplan-Meier method in the intent to treat (ITT) and subgroups previously identified as significantly prognostic.

Results

Table326P

	TCT			PFS2
	Abemaciclib + AI Events/N	Placebo + AI Events/N	HR (95% CI)	Abemaciclib + AI Events/N	Placebo + AI Events/N	HR (95% CI)
ITT
	93/328	82/165	0.513 (0.380, 0.691)	152/328	106/165	0.637 (0.495, 0.819)
ECOG PS
1	34/136	36/61	0.342 (0.214, 0.548)	64/136	45/61	0.504 (0.344, 0.740)
0	59/192	46/104	0.639 (0.435, 0.940)	88/192	61/104	0.762 (0.549, 1.059)
Bone-only disease
Yes	13/69	16/40	0.440 (0.211, 0.914)	21/69	23/40	0.523 (0.289, 0.945)
No	80/259	66/125	0.495 (0.357, 0.686)	131/259	83/125	0.660 (0.501, 0.871)
Liver metastases
Yes	21/47	21/31	0.572 (0.313, 1.048)	32/47	25/31	0.677 (0.401, 1.142)
No	72/281	61/134	0.504 (0.358, 0.709)	120/281	81/134	0.663 (0.500, 0.881)
Progesterone receptor status
Positive	66/255	57/128	0.529 (0.371, 0.753)	115/255	78/128	0.694 (0.520, 0.927)
Negative	25/70	24/36	0.414 (0.236, 0.725)	35/70	27/36	0.537 (0.325, 0.889)
Tumor grade
High	22/65	21/32	0.369 (0.203, 0.672)	27/65	23/32	0.418 (0.240, 0.730)
Intermediate/Low	52/179	48/96	0.512 (0.345, 0.757)	86/179	63/96	0.671 (0.484, 0.931)
Treatment-free interval
<36 months	15/44	18/32	0.465 (0.234, 0.924)	21/44	24/32	0.506 (0.281, 0.910)
≥36 months	32/95	18/41	0.798 (0.448, 1.422)	48/95	24/41	0.895 (0.548, 1.461)

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Conclusions

Addition of abemaciclib to AI prolonged PFS2 and TCT in the ITT and all prognostic subgroups.

Clinical trial identification

NCT02246621.

Editorial acknowledgement

Medical writing support was provided by Anchal Sood and editorial assistance by Rod Everhart of Syneos Health, and funded by Eli Lilly and Company.

Legal entity responsible for the study

Eli Lilly and Company.

Funding

Eli Lilly and Company.

Disclosure

M. Martín: Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Honoraria (self), Research grant / Funding (institution): Novartis; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): Eli Lilly and Company; Honoraria (self): Taiho Oncology; Honoraria (self): Pharmamar; Honoraria (self): Roche/Genentech. S. Johnston: Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Advisory / Consultancy: Eli Lilly and Company; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Pfizer; Advisory / Consultancy, Research grant / Funding (self): Puma Biotechnology; Speaker Bureau / Expert testimony: Eisai. J. Huober: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Eli Lilly and Company; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy: Hexal; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Celgene; Honoraria (self), Advisory / Consultancy: Abbvie. A. Di Leo: Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Celgene; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Eisai; Honoraria (self), Advisory / Consultancy: Genomic Health; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Eli Lilly and Company; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre Fabre; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Daiichi Sankyo; Advisory / Consultancy: Genentech; Advisory / Consultancy: Ipsen; Advisory / Consultancy, Travel / Accommodation / Expenses: Puma Biotechnology. V.A. Andre: Shareholder / Stockholder / Stock options, Full / Part-time employment: Eli Lilly and Company. H.R. Martin: Shareholder / Stockholder / Stock options, Full / Part-time employment: Eli Lilly and Company. M.C. Hardebeck: Shareholder / Stockholder / Stock options, Full / Part-time employment: Eli Lilly and Company. M.P. Goetz: Honoraria (self): Genomic Health; Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly and Company; Advisory / Consultancy: Biovica; Advisory / Consultancy: Novartis; Advisory / Consultancy: Sermonix; Advisory / Consultancy: Context Pharm; Research grant / Funding (institution): Pfizer. All other authors have declared no conflicts of interest.