GSK plc announced positive headline results from the DREAMM-7 phase III trial, revealing that Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) significantly improved overall survival (OS) in patients with relapsed or refractory multiple myeloma. The trial compared the Blenrep combination to daratumumab plus BorDex, a standard of care, demonstrating a statistically significant and clinically meaningful reduction in the risk of death.
The findings, set to be presented at the upcoming American Society of Hematology (ASH) Annual Meeting in December, mark a potential advancement in the treatment landscape for multiple myeloma. The data will be shared with health authorities to support regulatory filings, potentially offering a new treatment option for patients who have relapsed or become refractory to previous therapies.
Clinical Significance of DREAMM-7 Results
The DREAMM-7 trial is a multicenter, open-label, randomized study involving 494 participants with relapsed/refractory multiple myeloma who had previously undergone at least one prior line of therapy. Patients were randomized 1:1 to receive either belantamab mafodotin (2.5mg/kg intravenously every three weeks) in combination with BorDex or daratumumab in combination with BorDex.
The primary endpoint of the trial was progression-free survival (PFS), while key secondary endpoints included overall survival (OS), duration of response (DOR), and minimal residual disease (MRD) negativity rate. The statistically significant improvement in OS underscores the potential of the Blenrep combination to extend the lives of patients with this challenging disease.
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, stated, “The overall survival results from the DREAMM-7 trial underscore the potential for this Blenrep combination to extend the lives of patients with relapsed/refractory multiple myeloma. This is a statistically significant and clinically meaningful advancement for patients and potentially transformative for treatment. We look forward to sharing these data with health authorities and presenting the full results at next month’s American Society of Hematology Annual Meeting.”
Multiple Myeloma: An Unmet Need
Multiple myeloma, the third most common blood cancer globally, affects over 180,000 individuals each year. While generally treatable, it remains incurable, and patients often become refractory to available treatments. This highlights the urgent need for innovative therapies that can improve outcomes and extend survival.
Blenrep: A Targeted Approach
Blenrep is an antibody-drug conjugate that targets B-cell maturation antigen (BCMA), a protein highly expressed on multiple myeloma cells. By delivering a cytotoxic agent directly to these cells, Blenrep offers a targeted approach to treatment. The DREAMM clinical development program continues to evaluate Blenrep in earlier lines of treatment and in combination with novel therapies.
Regulatory Landscape
Based on the results of the DREAMM-7 and DREAMM-8 trials, belantamab mafodotin combinations have been filed in the US, European Union, Japan, United Kingdom, Canada, and Switzerland for the treatment of relapsed or refractory multiple myeloma. In China, belantamab mafodotin in combination with BorDex has received Breakthrough Therapy Designation and priority review.
