TRANSCRIPTION:
DR LOVE: So I was all set with this idea that the CDK4/6 inhibitors are somehow synergistic with hormonal therapy. And then I started to hear about abemaciclib, that you’ve done a lot of work on. And we did see data presented at ASCO on the so-called MONARCH 1 study. And the thing that was kind of cool about that is, that was just abemaciclib alone.
DR HURVITZ: Right.
DR LOVE: So Phase II. What did they see there, and what do you think it means?
DR HURVITZ: These were very heavily pretreated patients with ER-positive metastatic disease. And they were able to achieve an impressive progression-free survival and response rate with differing side-effect profile compared to palbociclib. There are a lot of theories about why they are having a different side-effect profile, but it’s not yet quite been worked out; maybe differential impact on CDK4 versus 6.
So they’re seeing less of the cytopenias and more liver toxicity in terms of transaminase elevation and diarrhea, which appears to be managed fairly well with the use of loperamide. But you hit it spot on. Single-agent activity, which hasn’t been reported for other CDK4/6 inhibitors, continuous dosing — it’s orally dosed twice a day, but you don’t need to hold it 7 days, in contrast to palbociclib and the other inhibitors. So the data is going to be very interesting.
They have breakthrough status granted to them, similar to the way that palbo was developed. So it’s unclear if they’ll be getting an accelerated approval anytime soon, but the FDA is watching their data very closely.
T, AC