FX.co ★ GSK Reports Positive Headline Results From DREAMM-7 Phase III Trial

GSK plc (GSK, GSK.L) recently disclosed promising top-line results from the interim evaluation of its ongoing DREAMM-7 Phase III clinical trial. This study is examining the effectiveness of Blenrep (belantamab mafodotin) when used in conjunction with bortezomib and dexamethasone (collectively known as BorDex) for treating relapsed or refractory multiple myeloma, particularly as a second-line or subsequent therapeutic approach.

The trial successfully achieved the crucial secondary endpoint related to overall survival (OS). Findings indicated that the combination therapy of belantamab mafodotin and BorDex substantially lowered the mortality risk compared to the traditional treatment regimen involving daratumumab coupled with BorDex.

As part of the ongoing DREAMM (Driving Excellence in Approaches to Multiple Myeloma) clinical development initiative, the program continues to assess the potential of belantamab mafodotin for earlier treatment stages, and in synergy with both innovative therapies and established standard care treatments.

Beyond the DREAMM-7 trial, the initiative also includes the ongoing Phase III DREAMM-8 study. This study is directly comparing the efficacy of belantamab mafodotin paired with pomalidomide and dexamethasone against the combination of bortezomib, pomalidomide, and dexamethasone.

A new Phase III trial targeting newly diagnosed multiple myeloma patients who are ineligible for transplants is slated to begin by the end of 2024 as part of the DREAMM agenda.

By 2024, combinations including belantamab mafodotin have been submitted for approval in the United States, European Union, Japan, United Kingdom, Canada, and Switzerland for the treatment of relapsed or refractory multiple myeloma, with evidence drawn from the DREAMM-7 and DREAMM-8 studies. In addition, China's National Medical Products Administration has designated this combination therapy as a Breakthrough Therapy and has expedited its regulatory review, motivated by findings from the DREAMM-7 trial.