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MONARCH 2 and MONARCH 3 are global, randomized, double\u2010blind, phase 3 studies of abemaciclib\/placebo + fulvestrant and abemaciclib\/placebo + nonsteroidal aromatase inhibitor (NSAI, anastrozole or letrozole), respectively. The East Asian population comprised 212 (31.7%) of the 669 intent\u2010to\u2010treat (ITT) population in the MONARCH 2 trial and 144 (29.2%) of the 493 ITT patients in the MONARCH 3 trial. In the East Asian population, median progression\u2010free survival (PFS) was significantly prolonged in the abemaciclib arm compared with placebo in both MONARCH 2 (hazard ratio [HR], 0.520; 95% confidence interval [CI], 0.362 to 0.747; <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a0.001; median: 21.2 vs 11.6\u00a0months) and MONARCH 3 (HR, 0.326; 95% CI, 0.200 to 0.531, <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a0.001; median: not reached vs 12.82\u00a0months). Diarrhea (MONARCH 2: 90%; MONARCH 3: 88%) and neutropenia (MONARCH 2: 68%; MONARCH 3: 58%) were the most frequent adverse events observed in the East Asian populations. Abemaciclib exposures and PK were similar in East Asians and the non\u2010East Asian populations of both trials. Abemaciclib in combination with ET in the East Asian populations of MONARCH 2 and MONARCH 3 provided consistent results with the ITT populations, demonstrating improvements in efficacy with generally tolerable safety profiles for patients with HR+, HER2\u2212 advanced breast cancer.<\/jats:p>","DOI":"10.1111\/cas.14877","type":"journal-article","created":{"date-parts":[[2021,3,9]],"date-time":"2021-03-09T06:56:54Z","timestamp":1615273014000},"page":"2381-2392","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Abemaciclib in combination with endocrine therapy for East Asian patients with HR+, HER2\u2212 advanced breast cancer: MONARCH 2 &amp; 3 trials"],"prefix":"10.1111","volume":"112","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1488-9958","authenticated-orcid":false,"given":"Masakazu","family":"Toi","sequence":"first","affiliation":[{"name":"Breast Cancer Unit Graduate School of Medicine Kyoto University Hospital Kyoto University Kyoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenichi","family":"Inoue","sequence":"additional","affiliation":[{"name":"Division of Breast Oncology Saitama Cancer Center Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7302-0278","authenticated-orcid":false,"given":"Norikazu","family":"Masuda","sequence":"additional","affiliation":[{"name":"National Hospital Organization Osaka National Hospital Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroji","family":"Iwata","sequence":"additional","affiliation":[{"name":"Department of Breast Oncology Aichi Cancer Center Hospital Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joohyuk","family":"Sohn","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology Department of Internal Medicine Yonsei University College of Medicine Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7894-8772","authenticated-orcid":false,"given":"In","family":"Hae Park","sequence":"additional","affiliation":[{"name":"Division of Hematology and Medical Oncology Department of Internal Medicine National Cancer Center Goyang Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seock\u2010Ah","family":"Im","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Seoul National University Hospital Cancer Research Institute Seoul National University College of Medicine Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shin\u2010Cheh","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Surgery Chang Gung Memorial Hospital Chang Gung University Medical College Taoyuan Taoyuan Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sotaro","family":"Enatsu","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P. 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