Benzinga - by Vandana Singh, Benzinga Editor.
GSK plc (NYSE:GSK) released headline results from an interim analysis of the DREAMM-8 phase III head-to-head trial evaluating Blenrep (belantamab mafodotin) combination for relapsed or refractory multiple myeloma.
The 302-participant trial evaluated Blenrep, combined with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex, as a second line and later treatment.
The trial met its primary endpoint of progression-free survival (PFS) at a pre-specified interim analysis and was unblinded early based on the recommendation by an Independent Data Monitoring Committee.
The belantamab mafodotin combination significantly extended the time to disease progression or death versus the standard of care combination.
A positive overall survival (OS) trend favoring the Blenrep combination was also observed at the time of this analysis.
The trial continues to follow up for OS. The safety and tolerability of the belantamab mafodotin regimen were broadly consistent with the known safety profile of the individual agents.
DREAMM-8 is the second phase 3 head-to-head belantamab mafodotin combination trial in the second line and later treatment for multiple myeloma to report positive results.
Findings from the DREAMM-7 Phase 3 head-to-head trial evaluating belantamab mafodotin in combination with bortezomib and dexamethasone (BorDex) versus daratumumab plus BorDex in the same treatment setting were presented at the American Society of Clinical Oncology Plenary Series in February 2024.
Detailed findings from DREAMM-8 will be presented at a future medical congress and shared with regulatory authorities.
In November 2022, GSK initiated the withdrawal process of the U.S. marketing authorization for Blenrep after a failed DREAMM-3 Phase 3 confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations.
The European Medicines Agency’s human medicines committee recommended not renewing the conditional marketing authorization for Blenrep (belantamab mafodotin) for multiple myeloma.
The company said data from the DREAMM-7 and DREAMM-8 phase 3 trials are event-driven.
Price Action: GSK shares are up 2.65% at $43.75 on the last check Thursday.
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