Abemaciclib monotherapy was shown to be active in refractory HR-positive mBC in a Phase I trial
MONARCH 1
study design:
MONARCH 1 (Phase II): Abemaciclib monotherapy in
HR+/ HER- ABC, after chemotherapy
2L/3L HR+/HER2– mBC
(inc. prior taxane)
N = 132
Abemaciclib 200 mg
BID D1–28
PD
Primary endpoint:
•
Objective response rate (investigator-assessed)
Key secondary endpoints:
•
Overall survival
•
Duration of response
•
Progression-free survival
Dickler M, et al. ASCO 2016
