GSK Reports Positive Headline Results From DREAMM-7 Phase III Trial

(RTTNews) - GSK plc (GSK, GSK.L), on Thursday, announced positive headline results from a planned interim analysis of the DREAMM-7 head-to-head phase III trial evaluating Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma.

The clinical trial met the key secondary endpoint of overall survival (OS), demonstrating that the combination of belantamab mafodotin with BorDex significantly diminished the risk of mortality in comparison to the standard of care involving daratumumab along with BorDex.

The DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical development program continues to investigate the efficacy of belantamab mafodotin in earlier lines of treatment and conjunction with both novel therapies and established standard care options.

In addition to the DREAMM-7 trial, this program encompasses the ongoing phase III DREAMM-8 trial, which is conducting a head-to-head evaluation of belantamab mafodotin in combination with pomalidomide and dexamethasone, versus the combination of bortezomib with pomalidomide and dexamethasone.

A phase III study in newly diagnosed transplant ineligible multiple myeloma is expected to be initiated by the end of 2024 as part of the DREAMM programme.

In 2024, belantamab mafodotin combinations have been filed in the United States, European Union, Japan, United Kingdom, Canada, and Switzerland for the treatment of relapsed or refractory multiple myeloma, based on the outcomes of the DREAMM-7 and DREAMM-8 clinical trials. Additionally, the National Medical Products Administration in China has granted Breakthrough Therapy Designation for belantamab mafodotin in combination with BorDex, along with a priority review for the regulatory application, also informed by the results of DREAMM-7.