The DREAMM-6 clinical trial was a Phase I study investigating the use of belantamab mafodotin, which is a BCMA-targeted antibody-drug conjugate, in combination with lenalidomide and dexamethasone for patients with relapsed/refractory multiple myeloma. The aims of this study was to try and elucidate what the recommended dose of both belantamab and lenalidomide should be in the combination in order to take this forward for a Phase III clinical trial...
The DREAMM-6 clinical trial was a Phase I study investigating the use of belantamab mafodotin, which is a BCMA-targeted antibody-drug conjugate, in combination with lenalidomide and dexamethasone for patients with relapsed/refractory multiple myeloma. The aims of this study was to try and elucidate what the recommended dose of both belantamab and lenalidomide should be in the combination in order to take this forward for a Phase III clinical trial.
So we looked at a number of different doses and a number of different schedules. We worked out that lenalidomide 25mg was the appropriate recommended dose. But we also looked at different schedules of belantamab, mainly to try and minimize toxicity, but to try and maximize efficacy. We looked at 2.5mg to be given every Q4W, but we also looked at a split dosing regimen and 1.9mg Q4W and 1.9mg Q8W. Now, that’s a very different regimen to what you’ve seen in the current schedules of belantamab monotherapy. But what we found was that by giving the lower dose, that’s 1.9mg Q8, the compliance and ability to deliver treatment was much higher than compared to the more intense dosing schedules. And also, when we look at the toxicity profile, the incidence of ocular side effects, namely blurring of vision and reduction in visual acuity, was significantly lower in the 1.98 Q8 dosing compared to the 2.5 QW. In terms of efficacy, it’s still a little bit early to tell, but broadly speaking, the efficacy looks fairly similar across the different groups.
So in summary, we’ve presented the initial Phase I data for belantamab with dexamethasone. It shows activity in patients with relapsed/refractory multiple myeloma. But importantly what it shows is that a lower intensity of dosing of belantamab seems to be better tolerated and more feasible compared to the higher dosing, and I think that will work out in better outcomes in the longer term.