Blenrep Combination Therapy Gains Regulatory Traction for Multiple Myeloma
Key Insights
The NMPA of China has accepted for review GSK's NDA for Blenrep (belantamab mafodotin) combined with bortezomib and dexamethasone (BVd) for relapsed or refractory multiple myeloma (search).
This regulatory filing is supported by the DREAMM-7 phase III trial, demonstrating statistically significant improvements in overall survival compared to daratumumab plus bortezomib and dexamethasone (DVd).
The FDA has also accepted for review Blenrep combinations with bortezomib plus dexamethasone (BVd) and pomalidomide plus dexamethasone (BPd), with a decision expected by July 23, 2025.
GSK's Blenrep (belantamab mafodotin) is making strides in regulatory approvals for its combination therapies aimed at treating relapsed or refractory multiple myeloma (search). The National Medical Products Administration (NMPA) of China has accepted for review a new drug application (NDA) for Blenrep in combination with bortezomib plus dexamethasone (BVd). This follows the NMPA granting priority review and Breakthrough Therapy Designation for the BVd combination earlier this year, potentially expediting the availability of this treatment option in China.
In the United States, the Food and Drug Administration (FDA) has also accepted for review a Biologics License Application (BLA) for Blenrep in combinations with bortezomib plus dexamethasone (BVd) and pomalidomide plus dexamethasone (BPd) for patients with multiple myeloma (search) who have received at least one prior line of therapy. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of July 23, 2025.
Supporting Clinical Data
These regulatory submissions are primarily supported by data from the Phase III DREAMM-7 and DREAMM-8 trials. The DREAMM-7 trial, a head-to-head study, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for BVd compared to daratumumab plus bortezomib and dexamethasone (DVd) in relapsed or refractory multiple myeloma (search). Furthermore, a subsequent planned interim analysis of DREAMM-7 revealed a statistically significant and clinically meaningful overall survival (OS) benefit favoring the Blenrep combination.
The DREAMM-8 trial also met its primary endpoint, showing statistically significant and clinically meaningful improvements in PFS for the belantamab mafodotin combinations compared to standard of care triplet combinations in relapsed or refractory multiple myeloma (search). While a positive trend in OS was observed in DREAMM-8, it was not statistically significant at the time of interim analysis, and follow-up is ongoing.
Multiple Myeloma Landscape
Multiple myeloma (search) is the third most common blood cancer globally, with over 180,000 new cases diagnosed each year. In China, the incidence has doubled in the past three decades, with approximately 30,000 new cases annually. The disease is generally considered treatable but not curable, and new therapies are needed as it commonly becomes refractory to available treatments.
About the DREAMM Trials
The DREAMM-7 trial is a multicenter, open-label, randomized study evaluating the efficacy and safety of belantamab mafodotin plus bortezomib and dexamethasone (BVd) versus daratumumab plus bortezomib and dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma (search) who have received at least one prior line of therapy. A total of 494 participants were randomized 1:1 to receive either BVd or DVd. Belantamab mafodotin was dosed at 2.5mg/kg intravenously every three weeks.
The DREAMM-8 trial is a similar multicenter, open-label, randomized trial evaluating belantamab mafodotin plus pomalidomide and dexamethasone (BPd) versus bortezomib plus pomalidomide and dexamethasone (PVd) in patients with relapsed/refractory multiple myeloma (search) previously treated with at least one prior line of therapy, including a lenalidomide-containing regimen. A total of 302 participants were randomized 1:1 to receive either BPd or PVd.
Blenrep Mechanism of Action
Blenrep is an antibody-drug conjugate comprising a humanized B-cell maturation antigen (search) (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. This targeted approach aims to deliver the cytotoxic agent directly to myeloma cells expressing BCMA.