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Belantamab Mafodotin Plus Bortezomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma: DREAMM 7
Dr. Fonseca: Dr. María Mateos provided in one of the plenary sessions an update on the DREAMM-7 clinical trial. This clinical trial was very important, and I would say courageous, because it did a head-to-head comparison of the combination of belantamab mafodotin in combination with bortezomib and dexamethasone versus daratumumab, bortezomib, and dexamethasone. That is the regimen that was previously reported by Dr. Palumbo in the CASTOR clinical trial.
And, in short, what she was able to show was that there was a very significant improvement in outcomes, both in overall survival as well as progression-free survival, for these patients. And this starts, of course, with an improvement in the response rate.
Ocular toxicity
Importantly, more and more we seem to be able to think about ways by which we can use belantamab mafodotin so that it does not cause excessive ocular toxicity. As of now, the drug is not available in the market since it was withdrawn because of the comparison of belantamab mafodotin versus pomalidomide. But I think this clinical trial really exemplifies how we might consider its use in the future.
Now, the medication, belantamab mafodotin, was used at the initial dose of 2.5 mg per kg, which was given intravenously every 3 weeks. But then one can make dose adjustments that, as I mentioned, can lead to improvements with regard to the keratopathy. The primary endpoint for this clinical trial was progression-free survival.
Remarkable progression-free survival
Now, this is a sizable clinical trial, and the intention-to-treat population, the belantamab arm, was 243 patients, and 251 patients were in the daratumumab arm.
What caught our eyes for this particular study was a separation between the curves for progression-free survival. First of all, the daratumumab arm had a PFS, as we would anticipate based on previous studies, and that came out to be 13.4 months. Belantamab mafodotin came out at 36.6 months. So, this is remarkable. This is on par with the best available regimens out there for this patient population. And when you do this subset analysis by patient subgroups, pretty much across the board, as is always the case, the forest plots might show, in some cases, that the confidence intervals go over the central line, but that usually reflects more than anything smaller subgroups of patients.
Improvements in overall survival and response rates
Now, interestingly, they are able to report also an improvement in overall survival. As an example, at 18 months, the overall survival is 84% versus 73%. The median was not reached in both arms but is clearly in favor of belantamab and also statistically significant.
The response rates were also improved with belantamab. The overall response rate was 82.7%. The overall response rate with the daratumumab arm was 71.3%, with associated improvements in the MRD negativity. And we see that, with the adjustments that were proposed for the dose of belantamab, there was no significant impact on the efficacy of this regimen.
So, I’m excited to see what follows, and I’m hoping that we will soon again have belantamab available through the FDA approval of this combination.
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