FDA to review combinations of Blenrep for multiple myeloma
Therapy is being considered with Velcade or Pomalyst, with dexamethasone
The U.S. Food and Drug Administration (FDA) will review GSK’s request to approve Blenrep (belantamab mafodotin) as part of a combination treatment for adults with relapsed or refractory multiple myeloma.
The therapy was pulled from the U.S. market in 2022 due to lack of evidence of its benefit when used alone, but it’s now being considered alongside Velcade (bortezomib) plus dexamethasone (BorDex) or Pomalyst (pomalidomide) plus dexamethasone (PomDex) in patients who’ve received at least one previous line of treatment.
In its biologics license application (BLA), GSK included data from the Phase 3 clinical trials DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623), where either combination of Blenrep about halved the risk of disease progression or death compared with standard-of-care treatment.
“We look forward to working with the FDA on this review,” Hesham Abdullah, MD, GSK’s senior vice president and global head of oncology research and development, said in a company press release. A decision is expected by mid-2025.
A similar application is under review in the European Union, where Blenrep had received conditional approval for adults who’d been given at least four previous lines of treatment for multiple myeloma. It was withdrawn from the European market this year for the same reason as in the U.S.
Multiple myeloma is a rare cancer that grows from plasma cells, the white blood cells in bone marrow that produce antibodies. It can be difficult to treat because it often becomes resistant to available treatment options. It also frequently relapses, meaning it comes back, despite treatment.
Results of DREAMM studies
An antibody-drug conjugate, Blenrep is composed of an antibody that’s designed to bind to BCMA, a protein on the surface of plasma cells. The antibody is linked to a toxic chemical called auristatin F, which is taken up by plasma cells, killing them.
Data from DREAMM-7 and DREAMM-8 showed statistically and clinically meaningful improvements in progression-free survival with Blenrep as administered by infusion into the bloodstream in a combination treatment, meeting their main goals.
In DREAMM-7, which included 494 adults with multiple myeloma who’d received at least one line of treatment, Blenrep plus BorDex reduced by 59% the risk of disease progression or death over Darzalex (daratumumab) plus BorDex. It also showed a significant improvement in overall survival.
The DREAMM-8 trial showed Blenrep plus PomDex was better than Velcade at prolonging progression-free survival in patients who’d been treated with at least one line of therapy, including lenalidomide, which is sold as Revlimid and generics.
“The evidence from DREAMM-7 and DREAMM-8 supporting our Blenrep combinations submission has been further strengthened by the statistically significant overall survival results from the DREAMM-7 trial,” Abdullah said.
Both clinical trials showed deeper, longer-lasting results with Blenrep combinations than with standard-of-care treatment. While many patients had side effects, the safety profile matched what’s expected from the individual medications.
If the Blenrep combinations are approved, “relapsed/refractory multiple myeloma treatment could be transformed by additional, efficacious treatment options with manageable side effects and community-based administration,” Abdullah said.
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