Hi, everyone.
My name is Doctor Lisa Leypoldt. I'm a medical doctor at University Medical Center in Hamburg-Eppendorf. And I'll try to give you a brief overview about the presentation.
I have the pleasure of giving it, which is, a presentation about our high-risk, newly diagnosed multiple myeloma clinical trial, which is called the GMNG-Concept Trial, or in short, just Concept Trial.
What does this study look at? Well, it is a phase two trial, so it's not randomized. So all the patients who get in there receive the same kind of treatment. And this treatment is a very effective regimen.
So it consists of four different therapies combined together, which is a CD38 antibody—Isatuximab—a second-generation proteasome inhibitor, then immunomodulatory JAK, lenalidomide, and dexamethasone. And this in short or altogether, Isa-KRd, as I will be using it moving forward.
So this study aimed at improving outcomes for high-risk newly diagnosed myeloma patients because it is a patient group or patient population that has not benefited to the same extent as standard-risk patients from many new therapies, and they still have an impaired outcome.
Back a few years ago, it was even as short as two to three years of survival after initial diagnosis. So this trial, by combining those four agents and giving them in an intensified treatment regimen for six cycles of induction, followed by high-dose therapy for those who are eligible, or two additional cycles for those who are not, followed by another four cycles of Isa-KRd—consolidation, as we call it—is then again followed by a long maintenance therapy with three of those four drugs: Isa-KR—so Isatuximab, Carfilzomib, and Lenalidomide—that in a dose-reduced schedule.
And the trial looked at the rate of MRD negativity at the end of consolidation. MRD negativity—you may have heard of it, or maybe not—and this is short for minimal residual disease and measures the most sensitive step that we have so far in looking at if there's any residual tumor burden, any myeloma burden. And we say MRD negative if we cannot find any myeloma cells, in this case, less than 1 in 100,000 cells.
So what I presented here is that of the cohort of transplant-eligible patients up until about 70 years of age. And those were 219 patients. So quite a large cohort and actually the largest purely high-risk trial cohort of a prospective clinical trial that we know of. Three out of four patients achieved MRD negativity at the end of consolidation, or 75%.
Looking at the whole duration of the study, it was almost nine out of ten patients. It was 87%, roughly, reaching MRD negativity. And MRD negativity is currently the strongest predictor for survival. And there also, we could now see with the median follow-up of 43 months—although this is a little different for the cohorts—the median progression-free survival was longer than six years. And for this cohort of purely high-risk patients, which is really a great achievement. And the median overall survival was not yet reached currently.
So in our eyes, this data underlines that Isa-KRd in this intensive treatment regimen as done in our Concept Trial can really be a standard of care option for those high-risk patients.
Please don't hesitate to reach out to myself or catch the eye of the trial, and we're happy to answer any questions.
Thank you.
HealthTree • June 26, 2025