IMS 2025 | The Phase I/II BelaCarD study of belantamab mafodotin, carfilzomib and dexamethasone in RRMM

So at this IMS we had the privilege of presenting the preliminary result of the Belacard study. This is an academic Phase II study that was run through the Australasian Myeloma Research Consortium, so AMARC, across 15 sites in Australia. The idea here is to explore the combination of belantamab mafodotin or belamaf in combination with carfilzomib and dexamethasone. So why this combination? Well, carfilzomib and dexamethasone is an accepted standard of care regimen for patients with relapsed/refractory multiple myeloma. And we know that belamaf induced clinical benefit when combined with other backbones such as bortezomib and dexamethasone in the DREAMM-7 study or pomalidomide and dexamethasone in the DREAMM-8 study. So this was simply a natural step forward, combining belamaf together with carfilzomib and dexamethasone with the expectation that we will get improved response based on the different mechanisms of actions of the drugs in this combination. So we enrolled 70 patients in this study with a median of two prior lines of treatment. Around a third of patients have had prior daratumumab and around 21% of patients were triple-class-exposed. Belamaf was given at a dose of 2.5 milligram per kilogram IV every eight weeks in combination with weekly carfilzomib and dexamethasone. In terms of safety profile, well, the good news is that this combination is very well tolerated. Hematological toxicity were low. In fact, grade three or more neutropenia, anemia and thrombocytopenia occurred in only 5%, 7% and 17% respectively. And infections of all grade only occurred in 39% of patients. And grade three pneumonia occurred in around 10% of patients. What about ocular adverse events that everyone talks about in regards to belantamab mafodotin? Well, in fact, we saw blurry vision occurred in around 50% of our patients, but severe blurry vision, that is grade three, only occurred in 9% of the patients and only 8% of patients develop a decline in the best corrected visual acuity to less than 20/50 in both eyes. That is the point at which reading starts to become affected. And importantly, at the time of data cutoff, most or in fact all of these ocular adverse events had either improved or resolved. In terms of efficacy, we saw an overall response rate of 87% with a CR or better of 41%. And after a median follow-up of 27 months, we saw a progression-free survival of 22.6 months with an overall survival of just over three years. So just to summarise, the combination of belantamab mafodotin with carfilzomib and dex is an effective combination in early line relapse and I think it stacks up very well against the evaluable standard of care at the moment in this space. And importantly, the ocular toxicities is quite manageable with dose modification and it looks like the every eight-week schedule seems to be maintained throughout treatment. So altogether, I think these data do support the ongoing exploration of belantamab mafodotin combinations in early line treatment in multiple myeloma.

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