Maura Dickler, MD
A handful of abstracts involving the CDK4/6 inhibitor abemaciclib (Verzenio) presented at the 2018 ASCO Annual Meeting demonstrated the agent’s efficacy and impact on quality of life (QOL) across subpopulations of patients with hormone receptor (HR)–positive, HER2-negative breast cancer.
during ASCO, Dickler, vice president, Late Phase Oncology Development, Eli Lilly and Company expanded on the findings with abemaciclib presented at this year’s meeting and what some of the next steps are for the CDK4/6 inhibitor.
OncLive: We saw interesting data presented with abemaciclib at the 2018 ASCO Annual Meeting. Can you discuss the findings with pre- and perimenopausal women?
: Dr Patrick Neven presented the data for abemaciclib in a pre- and perimenopausal group of women who participated in the MONARCH 2 trial. MONARCH 2 was a large, randomized phase III study where about 114 women were pre- and perimenopausal. But, everyone was given an GnRH agonist to make sure they were in menopause while they were receiving abemaciclib on study.
For that subgroup of 114 women, what this presentation nicely demonstrated was that there was a clear benefit of abemaciclib when added to fulvestrant in all patient subgroups, including the pre- and perimenopausal women included on this study. Therefore, it is reassuring to see that these data add to the evidence showing that abemaciclib specifically works in all subgroups of women. The MONARCH 2 data really are strong data showing that abemaciclib adds to the benefit of fulvestrant in this population of patients.
Have any differences between the 3 FDA-approved CDK4/6 inhibitors been identified?
There are no head-to-head studies of the CDK4/6 inhibitors, so we really can’t make inferences about the differences between the agents or the comparative effectiveness of each drug. We can really only comment on the trials that have been reported to date.
There really aren’t data to help guide the [decision] on which [drug] you would use. There are first-line trials with all 3 agents [as well as] second-line trials. Looking at each study, there are benefits in the first- and second-line settings with hazard ratios that are very similar. But, you can’t compare trials.
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