Belantamab mafodotin-blmf fails to extend PFS in advanced multiple myeloma
Belantamab mafodotin-blmf failed to extend PFS compared with pomalidomide and dexamethasone for adults with relapsed or refractory multiple myeloma, according to topline data from a confirmatory trial released by the agent’s manufacturer.
Belantamab mafodotin-blmf (Blenrep, GSK) is an antibody-drug conjugate comprising a humanized B-cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker.
The FDA granted accelerated approval to the agent in 2020 for adults with multiple myeloma who received at least four prior therapies, including an immunomodulatory agent, proteasome inhibitor and anti-CD38 antibody.
The FDA made the approval contingent on confirmed clinical benefit from the randomized phase 3 DREAMM-3 trial.
The open-label trial included 325 participants randomly assigned 2:1 to single-agent belantamab mafodotin-blmf dosed at 2.5 mg/kg every 3 weeks, or pomalidomide (Pomalyst, Bristol Myers Squibb) administered daily on days 1 to 21 of each 28-day cycle with once-weekly dexamethasone.
Researchers reported no significant improvement in PFS — the study’s primary endpoint — with belantamab mafodotin-blmf (median, 11.2 months vs. 7 months; HR = 1.03; 95% CI, 0.72-1.47).
Secondary endpoints included overall response rate, duration of response and OS.
Researchers reported ORRs of 41% with belantamab mafodotin-blmf vs. 36% for pomalidomide-dexamethasone, with longer median duration of response (not reached vs. 8.5 months) and a higher rate of 12-month responses (76.8% vs. 48.4%) in the belantamab mafodotin-blmf group.
OS data — which had reached only 37.5% maturity — showed no significant difference between the belantamab mafodotin-blmf and pomalidomide-dexamethasone groups (HR = 1.14; 95% CI, 0.77-1.68).
The safety and tolerability profile of belantamab mafodotin-blmf appeared consistent with prior reports. Researchers identified no new safety signals.
Data from the DREAMM-3 trial is being shared with health authorities, according to a GSK press release.
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