Blenrep regimen extends PFS in advanced multiple myeloma
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The combination of belantamab mafodotin, pomalidomide and dexamethasone extended PFS compared with standard care for patients with relapsed or refractory multiple myeloma, according to a topline data announcement.
Belantamab mafodotin (Blenrep, GSK) is an antibody-drug conjugate comprised of a humanized B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F via a noncleavable linker.
The randomized phase 3 DREAMM-8 included 302 participants who had received at least one prior line of multiple myeloma therapy — including a lenalidomide-containing regimen — and who had documented disease progression during or after their most recent therapy.
Researchers assigned half of the participants to belantamab mafodotin plus pomalidomide (Pomalyst, Bristol Myers Squibb) and dexamethasone. The other half of study participants received bortezomib plus pomalidomide and dexamethasone.
PFS served as the primary endpoint. Secondary endpoints included OS, overall response rate, duration of response, minimal residual disease negativity, safety, and patient-reported and quality of life outcomes.
An interim analysis showed the belantamab mafodotin regimen conferred a statistically significant PFS improvement, according to a GSK-issued press release. An independent data monitoring committee recommended unblinding the trial early.
Results showed a trend toward improved OS in the belantamab mafodotin group, and the trial will continue to follow survival outcomes.
The belantamab mafodotin regimen exhibited a safety profile consistent with the known profiles of the individual agents.
Complete data from DREAMM-8 will be presented at a medical meeting and shared with regulatory authorities, according to the release.