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Poster display session

2069 - Analysis of overall survival by tumor response in MONARCH 1, a phase 2 study of abemaciclib, a CDK4 and CDK6 inhibitor, in women with HR+/HER2- metastatic breast cancer (MBC) after chemotherapy for advanced disease


11 Sep 2017


Poster display session


Javier Cortés


Annals of Oncology (2017) 28 (suppl_5): v74-v108. 10.1093/annonc/mdx365


J. Cortés1, H.S. Rugo2, S.M. Tolaney3, V. Dieras4, D. Patt5, H. Wildiers6, S. Nanda7, A. Koustenis8, M.N. Dickler9, J. Baselga10

Author affiliations

  • 1 Clinical Research Department, Vall d'Hebron Institute of Oncology (VHIO), 08035 - Barcelona/ES
  • 2 Department Of Medicine, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco/US
  • 3 Department Of Medicine, Dana-Farber Cancer Institute, 2215 - Boston/US
  • 4 Department Of Medical Oncology, Institut Curie, 75248 cedex5 - Paris/FR
  • 5 Medical Oncology, Texas Oncology - Central Austin, Austin/US
  • 6 General Medical Oncology, University Hospitals Leuven, Leuven/BE
  • 7 Statistics-oncology, Eli Lilly and Company, Bridgewater/US
  • 8 Oncology, Eli Lilly and Company, Indianapolis/US
  • 9 Department Of Medicine, Memorial Sloan Kettering Cancer Center, New york/US
  • 10 Department Of Medicine, Memorial Sloan-Kettering Cancer Center, New York/US


Abstract 2069


Abemaciclib is a selective inhibitor of CDK4 and CDK6 dosed orally on a continuous schedule. Abemaciclib monotherapy (MONARCH 1) has demonstrated antitumor activity in heavily pretreated patients with HR+/HER2- MBC in terms of objective response rate (ORR= CR + PR) (19.7%; 95% CI: 13.3, 27.5), disease control rate (DCR= CR + PR + SD) (67.4%), and clinical benefit rate (CBR= CR + PR + SD ≥ 6 months [m]) (42.4%). At 18 m minimum follow-up, the median progression-free survival (PFS) was 5.95 m (95% CI: 4.21, 7.50) and median overall survival (OS) was 22.3 m (95% CI: 17.7, NR). Treatment was well tolerated. The results from exploring associations between ORR and OS are reported.


The primary objective of MONARCH 1 (NCT02102490) was to evaluate ORR per RECIST 1.1. Secondary objectives included duration of response (DoR), PFS, OS, DCR, CBR and safety. To explore whether responders have a better survival than nonresponders, a Cox proportional hazards model with responder status as a time-dependent covariate was used. A multivariable analysis using Cox regression model including baseline factors (ECOG PS, age, PgR status, liver mets, pleural/peritoneal mets, number of chemotherapies, prior capecitabine, number of metastatic sites), and response status was conducted to adjust for any differences in baseline prognostic factors in the two groups. As a supportive analysis, a landmark analysis at 6 m was performed.


26/132 patients (19.7%) achieved a best response of PR (responders). In the analysis where response was included as a time dependent covariate, patients who responded had a better OS (HR 0.31; 95% CI: 0.12, 0.77; p=.01) compared with nonresponders. After adjusting for potential baseline prognostic factors, results were consistent (HR 0.31; 95% CI: 0.12, 0.79; p=.01). Landmark analysis at 6 m supported results from previous analyses (HR 0.34; 95% CI: 0.12, 0.95; p=.04).


An association between ORR and OS was observed. Responders have a better OS compared to nonresponders.

Clinical trial identification


Legal entity responsible for the study

Eli Lilly and Company


Eli Lilly and Company


J. Cortés: Honoraria: Roche, Novartis, Eisai, Celgene, Pfizer. Consulting/advisor: Roche, Celgene, AztraZeneca, Cellestia Biotech, Biothera. H.S. Rugo: Grants/Research Support: GSK, Genentech/Roche, Novartis, Pfizer, Merck, Eisai, Plexxikon, Macrogenics, Lilly, OBI (all funding to UC Regents only). Speaker\'s Bureau: Genomic health. S.M. Tolaney: Grants/Research Support: Genentech, Pfizer, AstraZeneca, Exelixis, Eli Lilly, Novartis, Merck. V. Dieras: Honoraria: -Consultant: Roche-Genentech, Novartis, Lilly, Pfizer; -Speaker Roche, Novartis, GSK, EISAI, Pfizer; Travel expenses: Roche, Novartis, Pfizer, GSK, EISAI, AstraZeneca. D. Patt: Employee of Texas Oncology, and McKesson Specialty Health. H. Wildiers: Advisor for Eli Lilly and Company. S. Nanda, A. Koustenis: Employee of Eli Lilly and Company, and may hold company stocks. M.N. Dickler: Advisor: Eli Lilly. Consultant: TapImmune, Novartis, Genentech/Roche, AstraZeneca, Pfizer, Syndax, Puma biotechnology, and G1 Therapeutics. Research support: Lilly, Genentech/Roche, and Norvatis. All other authors have declared no conflicts of interest.

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