Clinical implications of a pooled analysis of endocrine therapy-naïve participants in MONARCH 2 investigating the use of abemaciclib plus fulvestrant to treat hormone receptor-positive metastatic breast cancer.
Sara A. Hurvitz, MD: In the pooled analysis of patients enrolled in the MONARCH 2 trial, who were treated with abemaciclib [Verzenio] plus fulvestrant [Faslodex] who were not previously ever treated with endocrine therapy, we saw that patients had an objective response rate of close to 60%, as well as a clinical benefit rate of around 77%. These are very consistent results that have been reported with abemaciclib in patients in the frontline setting. However, we do not yet know what the progression-free survival is from these patients, nor do we have data relating to the duration of response of this therapy. The data from about 110 patients enrolled in the MONARCH 2 trial is very interesting. They tell us the activity of abemaciclib in an endocrine therapy-naïve setting, and they underscore the efficacy data that we already know about in this agent. There are no new safety signals provided from this study. We actually saw similar rates of grade 3/4 diarrhea; around 13% with abemaciclib in this endocrine therapy- naïve setting, and about a 23% rate of grade 3/4 neutropenia. In all, I think this just provides further support of the activity of this agent in a very un-heavily treated patient population.
Transcript edited for clarity.