BCMA-Targeted Therapy for Relapsed/Refractory Multiple Myeloma - Episode 3
Ola Landgren, MD, PhD:There have been recent publications, the DREAMM-1 program, using the ADC [antibody-drug conjugate], theBCMA-targeted drug that you just talked about. Let’s talk about the design for that study, how that was carried out, and what the study showed.
Nina Shah, MD:This is a really important study for us as myeloma colleagues because it’s really showing this for the first time. It’s a first-in-class study for us to look at the type of a drug delivered to patients and what we can expect from it, both from an efficacy and a toxicity standpoint. In this particular study, it was a phase I/part 1, part 2 safety and dose expansiontype of study. They were able to look at different doses of this drug, theBCMAADC, and then see what was the safest and have that in an expansion cohort to understand the true efficacy.
The initial results of this study were presented in 2017 at the ASH [American Society of Hematology] Annual Meeting & Exposition and have been updated and published since then. What’s interesting about this is that patients were able to get the various doses, and they were ultimately able to come to an MTD, or a max-tolerated dose, at 3.4 mg/kg, and this is given every 3 weeks, and that was found to be the tolerated dosage. And overall 35 patients in the study were able to be treated. Then they were able to see what the true efficacy was in the dose-expansion cohort.
As you know, they had a pretty good outcome of 60% overall response rate. If you think about it, it’s pretty hard to do in relapsed-refractory myeloma patients. They also showed a median progression-free survival of around a year, which I think is actually very remarkable considering, as I talked about, that it’s really difficult as you go on and on in treatment lines to get a really durable progression-free survival duration of response.
Ola Landgren, MD, PhD:I would agree with that. So an overall response rate of 60%. If we compare studies, that is not a formal way of comparing drugs.
Nina Shah, MD:Right.
Ola Landgren, MD, PhD:We have to be cautious because every study is different. The patient populations are not the same, so you cannot just put the papers next to each other. If that was the case, then there would not be any randomized trials obviously.
Nina Shah, MD:Right.
Ola Landgren, MD, PhD:But still, if you’re looking to get a ballpark figure, when daratumumab was FDA approved back in 2015, that was based on about a 30% or so over response rate single drug in relapsed-refractory patients. Carfilzomib back in 2012 had about the 20% overall response rate. Again, the studies are different. The patient populations are different. So the numbers should not be compared with decimal points. You have to be a little cautious about the interpretation. But 60% is still a very high number, so it looks pretty good.
Nina Shah, MD:Yeah, it looks good. There are some interesting things about the study. This was a study where patients had a median of 5 prior lines of treatment. So not the most refractory but definitely pretty refractory. And the inclusion criteria, they had to have at least 2 prior lines. So they were pretty relapsed-refractory. And in this day and age, a lot of these patients have experienced or received daratumumab, etc, or transplant. I think it’s a pretty comparable population to what we would see in our clinic as a relapsed population.
Transcript edited for clarity.