GSK has reported positive headline data from the Phase III DREAMM-7 head-to-head clinical trial of Blenrep (belantamab mafodotin) as a second-line therapy to treat relapsed or refractory (R/R) multiple myeloma. 

The randomised, open-label, multicentre trial is designed to analyse the safety and efficacy of belantamab mafodotin plus bortezomib and dexamethasone (BorDex) versus daratumumab and BorDex combination.

It enrolled 494 R/R multiple myeloma patients who received a minimum of one line of therapy earlier and have progressed on or following the most recent therapy.

According to the interim efficacy assessment data, the trial met the primary endpoint of progression-free survival (PFS).

Treatment with belantamab mafodotin and BorDex was shown to prolong the time to progression of disease or mortality compared to daratumumab plus BorDex. 

A trend of clinically meaningful overall survival (OS) was also reported in the trial.

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The belantamab mafodotin combination treatment’s safety and tolerability were in line with the already reported profile of the individual products.

GSK R&D oncology global head and senior vice-president Hesham Abdullah said: “Patients with multiple myeloma need treatment options after first relapse that are efficacious, readily accessible and have novel mechanisms of action. 

“We are particularly encouraged by the potential for belantamab mafodotin when combined with BorDex to address high unmet need in relapsed/refractory multiple myeloma, given the head-to-head comparison with the daratumumab-based standard of care regimen.”

The latest development comes after the company received Health Canada approval for Jemperli (dostarlimab for injection) plus carboplatin and paclitaxel for the treatment of adult endometrial cancer patients.