ASH 2024 | Final results of a Phase I trial of belantamab mafodotin with KRd for myeloma

Belantamab, carfilzomib, lenalidomide, and dexamethasone is an investigator-initiated clinical trial that we performed at the Levine Cancer Institute. We enrolled patients after at least one prior line of treatment. Patients received belantamab mafodotin at two doses, 1.4 milligrams per kilogram and 1.9 milligrams per kilogram in a phase one dose escalation with dose expansion included in the trial in addition to KRd standard doses as approved for multiple myeloma. In this meeting we report the final results of the Phase I portion of the trial. 

We showed that the regimen was very well-tolerated. We were successfully able to give belantamab mafodotin at 1.9 milligrams per kilogram every other cycle. We did not see any dose-limiting toxicity in the first initial six patients as well as in the expansion cohort. Safety signals were as expected, mostly hematological in addition to keratopathy, which was reported in about 95% of the patients. All keratopathy incidents were reversible, and it was manageable by either dose reduction or dose delay. Mostly, we used dose delays for our patients, and I would say 100% of the patients received the first dose. For subsequent doses, it ranged between 30% to 70% of the patients were able to receive their subsequent doses of belantamab mafodotin, with the majority getting it – more than 50% of the patients in subsequent dosing. 

In regard to the efficacy, belantamab mafodotin showed really good efficacy results when compared with DREAMM-7 and DREAMM-8 trials. And that kind of encouraged us to proceed with this protocol, especially for the future for high-risk patients. During our Phase I results, we had 100% response rates. Close to 60% of the patients were stringent complete response. Out of those, also, we had more than half, about 60% of the patients were MRD-negative 10 to minus 5, and a significant portion was also MRD-negative 10 to minus 6. Suffice to say that the regimen was effective in a len-refractory population as well as showed good efficacy in patients with high-risk cytogenetics which was present in about a third of the patients roughly. 

Given those results we are proceeding with this regimen for Phase II portion. In Phase II it will be a multi-center study. We will enroll patients with high-risk, hopefully will include the new definition that is about to be published from the IMWG for high-risk patients. So, our results will be consistent with the new definition of high-risk disease and we’re very optimistic. Hopefully, we’ll see good results from it. The regimen will include four cycles induction, stem cell transplant for those who are eligible for stem cell transplant, and another four doses of consolidation then followed up by the triple maintenance regimen.

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