GSK Announces Positive Phase III DREAMM-7 Results for BCMA-Targeted ADC Blenrep in Relapsed/Refractory Multiple Myeloma
GSK
Pharmaceutical R&D Manufacturer
On November 27, GSK announced the interim efficacy analysis results of the DREAMM-7 head-to-head Phase III trial, which evaluated the efficacy of belantamab mafodotin (Blenrep) as a second-line treatment for relapsed or refractory multiple myeloma.The results showed that the trial met its primary endpoint of progression-free survival (PFS)., and indicate that compared with the existing standard treatment for relapsed/refractory multiple myeloma, daratumumab + BorDex, the combination of belantamab mafodotin with bortezomib + dexamethasone (BorDex) can significantly prolong the time to disease progression or death. A clinically significant trend in overall survival (OS) with a p-value < 0.0005 was also observed at the time of this analysis, and the trial will continue to follow up on OS.
Hesham Abdullah, Senior Vice President of GSK and Head of Global Oncology R&D, said"Patients with multiple myeloma need treatment options that are effective, easily accessible, and based on novel mechanisms of action after their first relapse. Considering the head-to-head comparison with the daratumumab-based standard of care, we are particularly encouraged by the potential of belantamab mafodotin in combination with BorDex for the treatment of relapsed/refractory multiple myeloma."
DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical development program will continue to evaluate the potential of belantamab mafodotin in earlier treatment and in combination with novel and standard therapies.This includes the ongoing head-to-head Phase III DREAMM-8 trial evaluating belantamab mafodotin in combination with pomalidomide and dexamethasone versus bortezomib in combination with pomalidomide and dexamethasone.Data from the DREAMM-8 trial is expected to be released in the second half of 2024.
Blenrep is an antibody-drug conjugate protein that seeks out and binds to BC.MA protein, BCMA protein is crucial for the survival of plasma cells, and myeloma cells also express this protein. This targeting mechanism enables Blenrep to specifically deliver the cytotoxic auristatin F payload to cancer cells.
November 7, 2022，In the DREAMM-3 trial, which was designed to evaluate the efficacy of single-agent Belantamab versus Pomalidomide in combination with low-dose Dexamethasone (Pom-Dex) in patients with relapsed/refractory multiple myeloma (RRMM),Blenrep did not meet the primary endpoint of survival.Compared with pomalidomide plus dexamethasone, Blenrep monotherapy failed to significantly improve progression-free survivalA few weeks later, at the request of the U.S. Food and Drug Administration, GSK withdrew Blenrep from the U.S. market.
In contrast, todayBlenrep inThe success achieved in the DREAMM-8 trial can be described as a remarkable turnaround.
Reference: Company's official website
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