GSK has reported positive interim headline data from the Phase III DREAMM-8 clinical trial of Blenrep (belantamab mafodotin) for the treatment of relapsed or refractory multiple myeloma (R/R MM).

The multicentre, open-label, randomised trial enrolled 302 participants who had previously received a minimum of one line of therapy, including a lenalidomide-containing regimen, and had documented disease progression.

Subjects were randomised into a 1:1 ratio to receive either Blenrep in combination with pomalidomide plus dexamethasone (PomDex) or a standard of care regimen of bortezomib plus PomDex.

Progression-free survival (PFS) was the trial’s primary endpoint while the trial is assessing overall survival (OS), overall response rate, duration of response, and safety, among other secondary endpoints.

According to the findings, the trial met its primary endpoint with the Blenrep combination regimen demonstrating a significant extension in the time patients lived without disease progression versus the standard of care.

In the trial, a positive OS trend favouring the Blenrep regimen was also reported.

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The DREAMM-8 trial is part of a series of studies evaluating the antibody-drug conjugate Blenrep, which targets the B-cell maturation antigen and is linked to the cytotoxic agent auristatin F.

This is the second Phase III head-to-head trial for Blenrep that has shown positive outcomes in the second-line treatment setting for multiple myeloma, following the earlier success of the DREAMM-7 trial.

The Blenrep regimen’s safety and tolerability profile was in line with already reported data of the individual drugs involved.

GSK R&D Global Head Oncology senior vice-president Hesham Abdullah said: “The results seen in both DREAMM-7 and DREAMM-8 provide strong clinical evidence of the robust efficacy shown with belantamab mafodotin in use with standard of care combinations.

“If approved, we believe these combinations have the potential to redefine the treatment of relapsed or refractory multiple myeloma and advance the standard of care. This is exciting news for patients given the high unmet medical need for both efficacious and easily administered therapies with differing mechanisms of action.”

GSK recently announced positive headline data from the EAGLE-1 Phase III clinical trial of gepotidacin, an oral bactericidal antibiotic designed to treat uncomplicated urogenital gonorrhoea.