DREAMM 8: Belantamab mafodotin offers hope for patients with RRMM

Belantamab mafodotin plus pomalidomide and dexamethasone (B-Pd) outperformed pomalidomide plus bortezomib and dexamethasone (P-Vd) for progression-free survival (PFS) in participants with relapsed or refractory multiple myeloma (RRMM). Seeing the manageable safety profile and ease of administration, the authors suggest that B-Pd can become a new standard of care for the population.

Belantamab mafodotin is an anti-B-cell maturation antigen (BCMA) antibody-drug conjugate and its efficacy and safety have previously been confirmed among participants with RRMM in the DREAMM-7 study, where B-Vd led to an improved PFS compared with daratumumab plus Vd [1].

The current phase 3 DREAMM 8 study (NCT04484623) compared the addition of belantamab mafodin versus bortezomib in regimes of B-Pd versus P-Vd in participants with RRMM (n=302) [2]. Participants were eligible if they had received at least one prior line of therapy, including lenalidomide. The primary endpoint was PFS and Prof. Meletious Dimopoulos (University of Athens, Greece) presented the late-breaking results.

After a median follow-up of 21.8 months, participants in the B-Pd arm had a significant PFS benefit over participants in the P-Vd arm (HR 0.52; 95% CI 0.37–0.73; P<0.001). The corresponding 12-month PFS rates were 71% and 51%, respectively. This result was consistent across subgroups, including lenalidomide-refractory and anti-CD38 therapy-refractory participants. The authors also noted a positive trend in overall survival, favouring B-Pd over P-Vd (HR 0.77; 95% CI 0.53–1.14). The 12-month overall survival rates were 83% and 76% (see Figure).

Figure: Survival of participants receiving B-Pd versus P-Vd [2]



B-Pd, belantamab mafodotin plus pomalidomide and dexamethasone; OS, overall survival; P-Vd, pomalidomide plus bortezomib and dexamethasone; NR, not reached.

“The exposure-adjusted safety profiles of the 2 treatment regimens were overall comparable,” explained Prof. Dimopoulos. Ocular events were seen in 83% of the participants on B-Pd. However, most of these events were manageable by dose holds and reductions in dosing frequency. In 9% of the cases, ocular events led to treatment discontinuation.

“The robust efficacy, manageable safety, and ease of administration of B-Pd support that this treatment regimen could become the new standard of care for patients with RRMM,” concluded Prof. Dimopoulos.

1. Mateos MV, et al. J Clin Oncol. 2024;42(36 suppl):439572–439572.
2. Dimopoulos MA, et al. Results from the randomized phase 3 DREAMM-8 study of belantamab mafodotin plus pomalidomide and dexamethasone vs pomalidomide plus bortezomib and dexamethasone in relapsed/refractory multiple myeloma. LB3440, EHA congress 2024, 13–16 June, Madrid, Spain.

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Posted on 12 August 202412 August 2024