GSK plc has announced positive headline results from the DREAMM-7 head-to-head 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 (r/r) multiple myeloma. The trial compared this combination to the standard of care, daratumumab plus BorDex, in patients who had received at least one prior line of therapy.
The DREAMM-7 trial met its key secondary endpoint of OS, demonstrating that the Blenrep combination significantly reduced the risk of death compared to the daratumumab-based regimen. These findings mark a clinically meaningful advancement for patients with r/r multiple myeloma, a population with limited treatment options and high unmet needs.
Clinical Significance
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, emphasized the potential of the Blenrep combination to extend the lives of patients. "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," he stated.
The full results, including detailed safety data, are scheduled for presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition on December 9, 2024.
Trial Design and Results
The DREAMM-7 trial is a multicenter, open-label, randomized study involving 494 participants with relapsed/refractory multiple myeloma. Patients were randomized 1:1 to receive either belantamab mafodotin (2.5mg/kg intravenously every three weeks) in combination with BorDex or daratumumab plus BorDex. The primary endpoint was progression-free survival (PFS), while key secondary endpoints included OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate.
Previous presentations of DREAMM-7 data at the American Society of Clinical Oncology (ASCO) Plenary Series in February 2024 and the ASCO Annual Meeting highlighted the initial findings, which were also published in the New England Journal of Medicine.
Regulatory Implications and Future Directions
Based on the DREAMM-7 and DREAMM-8 trial results, GSK has filed belantamab mafodotin combinations for regulatory approval in the US, European Union, Japan, United Kingdom, Canada, and Switzerland. In China, the National Medical Products Administration has granted Breakthrough Therapy Designation and priority review for belantamab mafodotin in combination with BorDex.
GSK is also planning to initiate a phase III study in newly diagnosed transplant-ineligible multiple myeloma patients by the end of 2024 as part of the DREAMM program. The ongoing DREAMM-8 trial continues to evaluate belantamab mafodotin in combination with pomalidomide and dexamethasone versus bortezomib in combination with pomalidomide and dexamethasone.
About Multiple Myeloma and Blenrep
Multiple myeloma is the third most common blood cancer globally, with over 180,000 new cases diagnosed each year. It is generally treatable but not curable, and new therapies are needed to address treatment resistance.
Blenrep is an antibody-drug conjugate comprising a humanized B-cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F. It is currently approved as monotherapy in several regions, including Hong Kong, Israel, and Singapore.
