My name is Laahn Foster. I'm an associate professor at the University of Virginia, and my practice mainly focuses on patients who have plasma cell disorders. So basically or mainly multiple myeloma and, amyloidosis. I'll be presenting an abstract during this meeting on the some subgroup analyses for the Phase 3 Auriga Study. And basically what that's looking at or I should say what the Auriga Study is.
The Auriga Study was a phase three study that, enrolled patients who are post-transplant, that are MRD positive, and had achieved a very good partial response or better. And they were, not exposed to Cd38 monoclonal antibody. So those patients were randomized to receive, daratumumab plus lenalidomide maintenance versus lenalidomide by itself, which is the standard of care.
And, what we were looking at is the MRD negativity rate at 12 months. So that's what that was looking at. And so for this meeting we'll be looking at the subgroup analysis. And seeing what the benefit is of adding daratumumab to lenalidomide in all different subgroups. So by patient demographic characteristics, disease characteristics and also by cytogenetic risk features.
Looking at all the different subgroups, it seemed that adding daratumumab to lenalidomide maintenance seemed to provide a benefit in all the different. So whether they were standard risk or high risk patients. And we looked at that by a lot of different ways by ISS staging, or by the different cytogenetic risks that patients might have, as part of their cytogenetic profile, I guess I should say.
And so, that was basically what has come out of the subgroup analysis. So it's in those patients who had not received daratumumab as part of their induction treatment right when they were diagnosed. So this is really kind of looking at what is the benefit of doing these two drugs together in the maintenance setting compared to what is the standard of just revlimid by itself?
And so with daratumumab, there are increased infections and that is not uncommon. So that is one additional thing that we saw. But that's not different from the other studies that were done, I think, to that in the subgroup analysis, what they did was we looked at, younger patients. So patients less than 65 or older, patients 65 and older, and there wasn't any additional safety concerns in the different like age groups.
And also looking at the black population, there wasn't any additional concerns with the addition of Daratumumab. So basically look like more of the patients achieved MRD negativity at that 12 month mark compared to patients that were just treated with lenalidomide by itself. And the, preliminary analysis that was presented in Brazil earlier this year, what it showed was that 50% of the patients achieved MRD negativity versus about 18%, with just lenalidomide by itself.
So it's clearly an improvement by adding that additional drug, I think just longer term follow up, you know, this data is we're looking at not all of the patients have completed their 36 cycles of treatment. And so we need longer term follow up to see how these people do I don't know, a few years from now and looking at sustained MRD negative rates.
HealthTree • December 18, 2024