ESMO Asia 2020: MONARCH 2 Update on Abemaciclib Plus Fulvestrant in East Asian Patients With Breast Cancer
Posted: Monday, December 7, 2020
In the multicenter phase III MONARCH 2 trial, abemaciclib plus fulvestrant appeared to be safe and active in patients with hormone receptor–positive, HER2-negative advanced breast cancer. This also seems to hold true for those recruited from Japan, Korea, and Taiwan, according to Chiun-Sheng Huang, MD, PhD, MPH, of the National Taiwan University Hospital, Taipei, and colleagues. The 4-year follow-up data from the East Asian subgroup, which were presented during the European Society for Medical Oncology (ESMO) Asia Virtual Congress 2020 (Abstract 450), seemed to be consistent with previous reports in the overall and East Asian study populations.
The study enrolled 669 patients who experienced disease progression on endocrine therapy; the East Asian subgroup comprised 212 patients. They were randomly assigned in a 2:1 ratio to receive fulvestrant in combination with either abemaciclib or a placebo.
A total of 89 overall survival events were reported. The median duration of overall survival was 48.9 months with the placebo plus fulvestrant; however, it was not reached with abemaciclib plus fulvestrant (hazard ratio = 0.798; P = .38). At 42 months, the overall survival rate was 64% with abemaciclib plus fulvestrant and 53% with the placebo plus fulvestrant.
The time to second objective disease progression (hazard ratio = 0.588; P = .001), time to chemotherapy (hazard ratio = 0.601; P = .008), and chemotherapy-free survival (hazard ratio = 0.573; P = .002) seemed to improve with abemaciclib plus fulvestrant, compared with the placebo plus fulvestrant. The safety profile in the East Asian subgroup appeared to be congruent with previous reports.
Disclosure: For full disclosures of the study authors, visit annalsofoncology.org.
