ASH 2024 | An analysis of Myeloma XI investigating lenalidomide maintenance in transplant-ineligible myeloma

I presented an updated analysis of the outcome of the randomization within the Myeloma XI trial that for transplant-ineligible patients, randomized patients between maintenance with lenalidomide, which was planned to continue to disease progression, or observation after they’d received their initial induction therapy. What we saw was that the lenalidomide maintenance was associated with a significantly prolonged progression-free survival in patients, and this seemed to be very consistent across patient subgroups. We couldn’t demonstrate a significant difference in overall survival. The overall survival seemed similar between the two arms, those patients who received lenalidomide and those patients who were observed. What we did in the analysis that I presented here was to look at whether we could determine how long patients should stay on lenalidomide maintenance. It’s always a discussion we have with patients, do they really need to continue on treatment if they’re responding well, or could they perhaps have a break from treatment? Our study wasn’t specifically designed to answer this question. For that, you need a randomized stopping study to compare what would happen in the event of stopping maintenance after starting. But what we were able to do was do a cut-point analysis of the data we have to try and look at all those patients who hadn’t progressed yet at different time points and see what the outcomes were compared to patients who were having lenalidomide at that time and patients who were still being observed at that time. What we see is a significant benefit in terms of progression-free survival for those patients beyond at least two years of therapy, but as you get further on, it’s harder to demonstrate that benefit. And so for me, this really suggests that if we were to look at these randomized approaches to really answering this question in detail, it would be about the two-year mark in transplant-ineligible patients that I would think would be the right place to do that.

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