EHA 2025 | Final analysis of the OPTIMISMM trial: pomalidomide, bortezomib, and dexamethasone in RRMM

Yes, well, OPTIMISMM is a really interesting trial in the sense, obviously, it’s been around for a while. And we obviously reported it primarily in 2019. So about six years ago. So this updated analysis and just to remind everyone, this was the pivotal trial for global approval, where we combined pomalidomide, bortezomib, and dexamethasone compared to the active comparator at that time, which was bortezomib and dexamethasone, and showed a substantial PFS advantage, response rate advantage, and at the same time, duration of response benefit, and then the suggestion of a survival advantage. In our updated survival analysis, what we were able to show is that the suggestion of a continued trend in favor of pomalidomide, bortezomib, and dexamethasone was sustained. But I think what’s very important to share is that we saw also the impact in our control group of the addition of pomalidomide, the addition of monoclonal antibody therapies, and how that impacted on the study group as a whole. So as you think about Phase IIIs in the modern era, survival advantages are sometimes a little more difficult to dissect simply because patients rightly have access to excellent next steps in terms of their therapy, and we’re seeing those benefits come in. So it doesn’t in any way diminish the value of pomalidomide-based therapy, but it simply points I think really to what I think is an important positive for patients which is the equipoise of randomized trials and the important point from the pomalidomide standpoint is obviously there was no long-term decrement to survival that could in any way be associated with pomalidomide use so we were encouraged to see this.

This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.