IMS 2025 | Belantamab plus pomalidomide and dexamethasone as a maintenance strategy for high-risk myeloma

Belantamab is an antibody drug conjugate and it has been shown to be efficacious and safer in combination with pomalidomide and dexamethasone based on the OCEAN AQUA trial that was presented by Suzanne Trudel years ago and also the DREAMM-8 study that has compared belantamab pomalidomide dexamethasone versus bortezomib pomalidomide dexamethasone for the primary endpoint of PFS and it met its primary endpoint and we see the benefit of this regimen. What we had done in our study is to use the same combination of belantamab, pomalidomide, dexamethasone as a maintenance strategy, not in a relapse setting. So here the primary endpoint is achieving a complete remission rate on the belantamab, pomalidomide, dexamethasone. There are several secondary endpoints including the PFS, including the overall survival, including the MRD negativity and so on. What is very interesting is this study is specifically meant for patients who have high-risk disease where the combination strategies have shown to have deeper remissions and prolonged remissions. And the high risk is defined as somebody having plasma cell leukemia, somebody having deletion 17P, somebody having translocation 4;14 or 14;16 or 14;20. What was not included when the study was devised is the new IMWG-IMS definition. And we have a proposal to further enroll 20 more patients on this cohort to include those patients that qualify for the new definition of the IMWG. So currently, we have 25 patients that were enrolled. And among these 25 patients, 17 were available for efficacy, 18 were available for safety. Among the 17 patients, it’s 100% response rate and the CR rates were seen in 80% of the patients. From a safety perspective, the safety run-in was done on the first six patients. We saw one DLT, which is a grade 3 ocular toxicity. And what we learned from this is we probably could extend the dosing. So now the dosing schedule that we’ve given in the study is 1.9 milligram per kilogram given every eight weeks. After the DLT and after looking at the adverse events in the first six patients, the dosing schedule was changed to 1.9 milligram per kilogram given every 56 days, that is every two cycles for the first two cycles. And then the patients have an option to change to every three months. So with this schedule, pomalidomide is given at 2 milligram. Pomalidomide was given at 4 milligram. There’s 1 to 21, 28-day basis, and the dexamethasone could be tapered down to 20 milligrams as soon as possible. In elderly patients, we start with 20 milligrams. The rest of them, we start with 40 milligram weekly. So the combo is very safe in the 12 next evaluable patients, so making a total of 18 evaluable patients. And the safety in the next 12 evaluable patients at the new schedule that we were talking about, there’s zero grade 3 toxicities so far. So this is an immediate follow-up of six months. We’re able to show that the efficacy is very good with 100% of the patients, high-risk patients, not progressing. And the safety with no grade 3 events on the expansion cohort of the 12 patients who received the extended schedule at 1.9 milligram of belantamab given every two months for the first two cycles then given every three months. We’re expecting a longer follow-up and the extension of the study to include 24 other patients with the new IMWG-IMS criteria.

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