ASH 2024 | The REST study: isatuximab-bortezomib-lenalidomide in elderly patients with myeloma

Yeah, this is a frontline study for the elderly. It’s sort of a bit similar to IMROZ, which will be approved in the US, it will be approved in Europe quite soon, which is frontline treatment for the elderly with isatuximab, a CD38 antibody, bortezomib, lenalidomide, and dexamethasone. In that study, or CEPHEUS, which is the sort of Johnson & Johnson equivalent, and they have both proved that adding CD38 antibody to VRd is a good thing. Both these studies had a cut-off at 80 years old (you’re not allowed to be in the study if you’re over 80) and the median age in both studies was about 72. So they are not very old patients. And in older patients, the tolerance of these drugs is worse, especially dexamethasone, and patients do get a lot of dexamethasone. Elderly patients in the beginning of myeloma have a quite high mortality the first three or four months, usually by infections and dexamethasone is increasing infections. 

So we thought that keeping isatuximab and bortezomib and lenalidomide, but removing dex and give it to all patients in the elderly setting, not just those under 80 who are fit. So the median age of the patients was 77 years old, so quite much older, 15% over 80. And we showed, and the primary endpoint of these 50 patients, it’s a Phase II study, was MRD negativity after 18 cycles. And when we started the study, we didn’t know about this IMROZ data and CEPHEUS, so we wanted to beat the MAIA schedule, daratumumab, lenalidomide, dex in the elderly. And their MRD negativity rate was about 25%, MRD negativity is CR. So we wanted to beat that with this study, by removing the dexamethasone and actually adding bortezomib instead. So the primary endpoint is being presented here. MRD negativity rates are 38%, so quite significantly more than the MAIA schedule, which was the intention. It is below the IMROZ, which is 50-something, but they are a much younger population also. So I think this is demonstrating a very feasible way of using the IMROZ regimen on also the more elderly and frail. And when you use one, when you reduce to ours, it’s you know, that’s it’s difficult to have clear rules on that, but it gives you data on on the efficacy you can expect with this kind of dose reductions. This abstract has gotten an Abstract Achievement Award at this Congress, which is nice, and it will be published in Leukemia Hematology just after ASH.

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