Journal Article
. 2019 Sep; 6(1):116-124.
doi: 10.1001/jamaoncol.2019.4782.

The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy-MONARCH 2: A Randomized Clinical Trial

George W Sledge 1 Masakazu Toi 2 Patrick Neven 3 Joohyuk Sohn 4 Kenichi Inoue 5 Xavier Pivot 6 Olga Burdaeva 7 Meena Okera 8 Norikazu Masuda 9 Peter A Kaufman 10 Han Koh 11 Eva-Maria Grischke 12 PierFranco Conte 13 Yi Lu 14 Susana Barriga 15 Karla Hurt 14 Martin Frenzel 14 Stephen Johnston 16 Antonio Llombart-Cussac 17 
  • PMID: 31563959
  •     114 citations


Importance: Statistically significant overall survival (OS) benefits of CDK4 and CDK6 inhibitors in combination with fulvestrant for hormone receptor (HR)-positive, ERBB2 (formerly HER2)-negative advanced breast cancer (ABC) in patients regardless of menopausal status after prior endocrine therapy (ET) has not yet been demonstrated.

Objective: To compare the effect of abemaciclib plus fulvestrant vs placebo plus fulvestrant on OS at the prespecified interim of MONARCH 2 (338 events) in patients with HR-positive, ERBB2-negative advanced breast cancer that progressed during prior ET.

Design, Setting, And Participants: MONARCH 2 was a global, randomized, placebo-controlled, double-blind phase 3 trial of abemaciclib plus fulvestrant vs placebo plus fulvestrant for treatment of premenopausal or perimenopausal women (with ovarian suppression) and postmenopausal women with HR-positive, ERBB2-negative ABC that progressed during ET. Patients were enrolled between August 7, 2014, and December 29, 2015. Analyses for this report were conducted at the time of database lock on June 20, 2019.

Interventions: Patients were randomized 2:1 to receive abemaciclib or placebo, 150 mg, every 12 hours on a continuous schedule plus fulvestrant, 500 mg, per label. Randomization was stratified based on site of metastasis (visceral, bone only, or other) and resistance to prior ET (primary vs secondary).

Main Outcomes And Measures: The primary end point was investigator-assessed progression-free survival. Overall survival was a gated key secondary end point. The boundary P value for the interim analysis was .02.

Results: Of 669 women enrolled, 446 (median [range] age, 59 [32-91] years) were randomized to the abemaciclib plus fulvestrant arm and 223 (median [range] age, 62 [32-87] years) were randomized to the placebo plus fulvestrant arm. At the prespecified interim, 338 deaths (77% of the planned 441 at the final analysis) were observed in the intent-to-treat population, with a median OS of 46.7 months for abemaciclib plus fulvestrant and 37.3 months for placebo plus fulvestrant (hazard ratio [HR], 0.757; 95% CI, 0.606-0.945; P = .01). Improvement in OS was consistent across all stratification factors. Among stratification factors, more pronounced effects were observed in patients with visceral disease (HR, 0.675; 95% CI, 0.511-0.891) and primary resistance to prior ET (HR, 0.686; 95% CI, 0.451-1.043). Time to second disease progression (median, 23.1 months vs 20.6 months), time to chemotherapy (median, 50.2 months vs 22.1 months), and chemotherapy-free survival (median, 25.5 months vs 18.2 months) were also statistically significantly improved in the abemaciclib arm vs placebo arm. No new safety signals were observed for abemaciclib.

Conclusions And Relevance: Treatment with abemaciclib plus fulvestrant resulted in a statistically significant and clinically meaningful median OS improvement of 9.4 months for patients with HR-positive, ERBB2-negative ABC who progressed after prior ET regardless of menopausal status. Abemaciclib substantially delayed the receipt of subsequent chemotherapy.

Trial Registration: identifier: NCT02107703.

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Breast Cancer Therapeutics and Biomarkers: Past, Present, and Future Approaches.
Jason Schick, Raquel P Ritchie, Carolina Restini.
Breast Cancer (Auckl), 2021 May 18; 15. PMID: 33994789    Free PMC article.
Luminal Metastatic Breast Cancer: Current Concepts and Future Approaches.
Johannes Ettl.
Breast Care (Basel), 2021 May 21; 16(2). PMID: 34012364    Free PMC article.
First Experiences with Alpelisib in Clinical Routine: Case Reports from a German Breast Center.
Anna Hester, Franziska Henze, +2 authors, Rachel Wuerstlein.
Breast Care (Basel), 2021 May 21; 16(2). PMID: 34012367    Free PMC article.
Treatment of Luminal Metastatic Breast Cancer beyond CDK4/6 Inhibition: Is There a Standard of Care in Clinical Practice?
Athanasios Mavratzas, Frederik Marmé.
Breast Care (Basel), 2021 May 21; 16(2). PMID: 34012366    Free PMC article.
Activity of Combined Androgen Receptor Antagonism and Cell Cycle Inhibition in Androgen Receptor Positive Triple Negative Breast Cancer.
Jessica L Christenson, Kathleen I O'Neill, +8 authors, Jennifer K Richer.
Mol Cancer Ther, 2021 Mar 17; 20(6). PMID: 33722849    Free PMC article.
Current Landscape of Targeted Therapy in Hormone Receptor-Positive and HER2-Negative Breast Cancer.
Samitha Andrahennadi, Amer Sami, +2 authors, Shahid Ahmed.
Curr Oncol, 2021 Jun 03; 28(3). PMID: 34064867    Free PMC article.
Liquid Biopsy: A New Tool for Overcoming CDKi Resistance Mechanisms in Luminal Metastatic Breast Cancer.
Miriam González-Conde, Celso Yañez-Gómez, Rafael López-López, Clotilde Costa.
J Pers Med, 2021 Jun 03; 11(5). PMID: 34068388    Free PMC article.
Circulating Biomarkers of CDK4/6 Inhibitors Response in Hormone Receptor Positive and HER2 Negative Breast Cancer.
Ilenia Migliaccio, Angela Leo, +6 authors, Luca Malorni.
Cancers (Basel), 2021 Jun 03; 13(11). PMID: 34072070    Free PMC article.
Abemaciclib in combination with endocrine therapy for East Asian patients with HR+, HER2- advanced breast cancer: MONARCH 2 & 3 trials.
Masakazu Toi, Kenichi Inoue, +12 authors, George W Sledge.
Cancer Sci, 2021 Mar 10; 112(6). PMID: 33686753    Free PMC article.
Breast cancer liver metastasis: current and future treatment approaches.
Narmeen S Rashid, Jacqueline M Grible, Charles V Clevenger, J Chuck Harrell.
Clin Exp Metastasis, 2021 Mar 07; 38(3). PMID: 33675501    Free PMC article.
Cost-Effectiveness Analysis of Abemaciclib Plus Fulvestrant in the Second-Line Treatment of Women With HR+/HER2- Advanced or Metastatic Breast Cancer: A US Payer Perspective.
Yingcheng Wang, Mingjun Rui, +2 authors, Pingyu Chen.
Front Med (Lausanne), 2021 Jun 22; 8. PMID: 34150798    Free PMC article.
Methods and Designs of Modern Breast Cancer Confirmatory Trials.
Julien Péron, Thibaut Reverdy, +3 authors, Gilles Freyer.
Cancers (Basel), 2021 Jul 03; 13(11). PMID: 34199352    Free PMC article.
Oligometastatic Breast Cancer: How to Manage It?
Vittoria Barberi, Antonella Pietragalla, +6 authors, Alessandra Fabi.
J Pers Med, 2021 Jul 03; 11(6). PMID: 34207648    Free PMC article.
Abemaciclib as initial therapy for advanced breast cancer: MONARCH 3 updated results in prognostic subgroups.
Stephen Johnston, Joyce O'Shaughnessy, +7 authors, Matthew P Goetz.
NPJ Breast Cancer, 2021 Jun 24; 7(1). PMID: 34158513    Free PMC article.
AGO Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2021.
Marc Thill, Michael Friedrich, +43 authors, Nina Ditsch.
Breast Care (Basel), 2021 Jul 13; 16(3). PMID: 34248463    Free PMC article.
Ribociclib-Induced Pneumonitis: A Case Report.
Ghada Algwaiz, Ahmed Ali Badran, Mahmoud A Elshenawy, Taher Al-Tweigeri.
Breast Care (Basel), 2021 Jul 13; 16(3). PMID: 34248473    Free PMC article.
Patient-Reported Outcomes Predict Progression-Free Survival of Patients with Advanced Breast Cancer Treated with Abemaciclib.
Sarah Badaoui, Ganessan Kichenadasse, +2 authors, Ashley M Hopkins.
Oncologist, 2021 Apr 30; 26(7). PMID: 33914991    Free PMC article.
Clinical and Pharmacologic Differences of CDK4/6 Inhibitors in Breast Cancer.
Mridula A George, Sadaf Qureshi, +2 authors, Shridar Ganesan.
Front Oncol, 2021 Jul 31; 11. PMID: 34327137    Free PMC article.
Moving beyond PARP Inhibition: Current State and Future Perspectives in Breast Cancer.
Michela Palleschi, Gianluca Tedaldi, +3 authors, Ugo De Giorgi.
Int J Mol Sci, 2021 Aug 08; 22(15). PMID: 34360649    Free PMC article.
Prognostic Factors for Overall Survival in Patients with Hormone Receptor-Positive Advanced Breast Cancer: Analyses From PALOMA-3.
Hope S Rugo, Massimo Cristofanilli, +10 authors, Nicholas C Turner.
Oncologist, 2021 May 27; 26(8). PMID: 34037282    Free PMC article.
Optimizing treatment selection, and sequencing decisions for Management of HR-Positive, HER2-Negative advanced breast cancer - Proceedings from breast cancer expert group meeting.
Shaheenah Dawood, Maria Konstantionva, +6 authors, Sergio Simon.
BMC Proc, 2021 Aug 11; 15(Suppl 10). PMID: 34372853    Free PMC article.
Real-world clinical profile, treatment patterns and patient-reported outcomes in a subset of HR+/HER2- advanced breast cancer patients with poor prognostic factors: data from an international study.
A Davie, G Cuyun Carter, +6 authors, X Pivot.
ESMO Open, 2021 Aug 10; 6(4). PMID: 34371379    Free PMC article.
Establishment of Prognostic Nomograms for Predicting the Survival of HR-Positive, HER2-Negative Metastatic Breast Cancer Patients Treated with Everolimus.
Fangfang Duan, Chenge Song, +10 authors, Wen Xia.
Drug Des Devel Ther, 2021 Aug 20; 15. PMID: 34408400    Free PMC article.
Radiological and pathological assessment of response to neoadjuvant CDK4/6 inhibitor and endocrine treatments in a real-life setting-initial results.
Mikko Moisander, Annukka Salminen, +7 authors, Otso Arponen.
Acta Radiol Open, 2021 Aug 24; 10(8). PMID: 34422318    Free PMC article.
Japanese subpopulation analysis of MONARCH 2: phase 3 study of abemaciclib plus fulvestrant for treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that progressed on endocrine therapy.
Kenichi Inoue, Norikazu Masuda, +13 authors, Masakazu Toi.
Breast Cancer, 2021 Apr 03; 28(5). PMID: 33797023    Free PMC article.
Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial.
Patrick Neven, Hope S Rugo, +8 authors, George W Sledge.
Breast Cancer Res, 2021 Aug 25; 23(1). PMID: 34425869    Free PMC article.