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.
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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.
“Single agent belamaf compared to pomalidomide and dexamethasone demonstrated longer median PFS with 11.2 vs 7.2 months, though the PFS hazard ratio did not reach statistical significance. [We saw] deeper and more durable responses with belamaf treatment,” 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.
