COMy 2026 | Optimal dosing strategy for BVd in R/R MM: outcomes from the DREAMM-6 arm B trial

We recently published the DREAMM-6 clinical trial, which was a phase 1 study and was the prelude of the DREAMM-7 study, which is the phase 3 study leading to the licensing and registration of belantamab mafodotin with bortezomib and dexamethasone. Now, DREAMM-6 gives us some new insights compared to what you saw in the phase 3 study, because DREAMM-6 was all about trying to work out the correct schedule and correct dose of belantamab mafodotin to be given with bortezomib and dexamethasone. And so we looked at a number of different schedules. We looked at higher doses of belantamab, and we dropped the dose right down to 1.9 and 1.4, and we spaced out the dosing administration, going out to Q8 dosing. We also looked at something called step-down stretch, where we gave a higher dose initially, and then we stepped down to a lower dose. And we looked at splitting the dose of belantamab mafodotin to try and reduce the peak levels of the drug in an attempt to reduce the corneal toxicity. And just to remind everyone that belantamab mafodotin is a very effective BCMA targeted antibody-drug conjugate but does come with the side effects of corneal toxicity, which leads to blurring of vision. And so really DREAMM-6 was about trying to optimize that in a way. What we found was that it was very important to start off at a good dose of belantamab mafodotin. And this is shown in the PK analysis, showing that in order to get adequate venous levels in the blood, you need to be starting with a dose of at least 2.5 milligrams per kilogram. Starting at a lower dose, you get a much slower increase in blood levels, which will probably lead to reduced efficacy. So, the PK data strongly supports starting at a high dose. Now, when we look at the toxicity data, we see that continuing at 2.5 milligrams frequently led to high levels of corneal toxicity, treatment interruptions and treatment delays. Whereas if we move down and step down to 1.9 and move into the Q8 weekly dosing, then that concurs with less corneal toxicity and a higher rate of compliance with belantamab mafodotin. So, in the end, we would recommend starting at a higher dose, that’s 2.5, and then stepping down to 1.9 Q8 dosing as soon as possible. And that fits with good levels of PK and reducing the level of corneal toxicity.

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