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Single-agent belantamab mafodotin (belamaf) may not improve progression-free survival (PFS) compared with pomalidomide plus low-dose dexamethasone (Pd) among patients with relapsed or refractory multiple myeloma (MM), according to research presented at the ASCO Annual Meeting 2023. PFS rates appeared comparable for the 2 drugs, however, and overall survival data are not yet mature enough to analyze.
Belamaf is a first-in-class drug that directly targets BCMA, inducing cell death through direct cell killing, as well as immune-mediated mechanisms.
For the DREAMM-3 study (ClinicalTrials.gov Identifier: NCT04162210), researchers aimed to determine whether belamaf induces superior PFS rates to Pd among patients with relapsed/refractory MM. Katja Weisel MD, of the University Medical Center of Hamburg-Eppendorf in Germany, presented PFS data from DREAMM-3.
Overall, 325 patients were randomly assigned to receive belamaf (n=218) or Pd (n=107). In the belamaf and Pd groups, the median ages were 68 and 68 years, respectively, 54% and 62% of patients were male, and 76% and 73% of patients had stage I/II disease.
The median follow-up periods for belamaf and Pd were11.5 and 10.8 months, respectively, and at time of analysis, 26% and 21% of patients remained on treatment.
Analysis showed a numerically superior median PFS for belamaf (11.2 months vs 7 months with Pd), but the hazard ratio (HR) showed no significant difference between the groups (HR, 1.03; P =.558).
The overall response rates in the belamaf vs Pd groups were 41% and 36%, respectively, although the minimal residual disease negativity rate was higher with belamaf (7% vs 0%). Median duration of response also appeared to be higher with belamaf (not reached vs 8.5 months with Pd).
Overall survival data were only 37.5% mature, but there was no significant difference at time of analysis (HR, 1.14; P =.746).
Grade 3 or 4 adverse events were observed in 76% of patients in the belamaf group vs 70% of patients in the Pd group; 1 treatment-related death was noted in the Pd group.
“While the study did not meet its primary objective of demonstrating PFS superiority, single-agent belamaf appears to show similar levels of clinical activity to a doublet regimen,” Dr Weisel said.
Disclosures: This research was supported by GSK. Please see the original reference for a full list of disclosures.
Reference
Weisel K, Hungria VTM, Radinoff A, et al. A phase 3, open-label, randomized study to evaluate the efficacy and safety of single-agent belantamab mafodotin (belamaf) compared to pomalidomide plus low-dose dexamethasone (Pd) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): DREAMM-3. ASCO 2023. June 2-6, 2023. Abstract8007.
This article originally appeared on Hematology Advisor
