GSK plc announced positive headline results from a planned interim efficacy analysis of the DREAMM-7 head-to-head phase III trial evaluating belantamab mafodotin as a second-line treatment for relapsed or refractory multiple myeloma. The trial met its primary endpoint of progression-free survival (PFS) and showed that belantamab mafodototin when combined with bortezomib plus dexamethasone (BorDex) significantly extended the time to disease progression or death versus daratumumab plus BorDex, an existing standard of care for relapsed/refractory multiple myeloma". A strong and clinically meaningful overall survival (OS) trend with nominal p value < 0.0005 was also observed at the time of this analysis, and the trial continues to follow up for OS.

The safety and tolerability of the belantamab mafodoti regimen was consistent with the known safety profile of the individual agents. Results from the interim analysis will be presented at an upcoming scientific meeting and shared with health authorities. The DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical development programme continues to evaluate the potential of belantamab mafod78 in early lines of treatment and in combination with novel therapies and standard of care treatments.

This includes the ongoing head-to-head phase II DREAMM-8 trial evaluating belantamab mAFodotin in combination with pomalidomide and dexamethasone versus bortezomib in combination with pomalidOMide and dexamethas one. DREAMM-8 data are expected in the second half of 2024. The DREAMM-7 phase III clinical trial is a multic entre, open-label, ran domised trial evaluating the efficacy and safety of belantamab mafODotin in combination with bortezomib and dexamethasone (BorDex) compared to a combination of daratumumab and BorDex in patients with relapsed/refractory Multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy.

A total of 494 participants were randomised at a 1:1 ratio to receive either belantamab mafodots in combination with BorDex or a combination of daratumUMab and BorDex. Participants had been previously treated with at least one prior lines of multiple myeloma therapy with documented disease progression during or After their most recent therapy. Belantamab mafodotin was dosed at 2.5mg/kg intravenously every three weeks.

The primary endpoint is progression-free survival as per an independent review committee. The key secondary endpoints include overall survival, duration of response, and minimal residual disease negativity rate as assessed by next-generation sequencing. Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.

There are approximately 176,000 new cases of multiple myeloma diagnosed globally each year. Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.