GSK's Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BorDex) has demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit in the DREAMM-7 phase III trial for patients with relapsed or refractory multiple myeloma. The trial compared the Blenrep combination to daratumumab plus BorDex, a standard of care, showing a significant reduction in the risk of death.
The DREAMM-7 trial is a multicenter, open-label, randomized study involving 494 participants with relapsed/refractory multiple myeloma who had received at least one prior line of therapy. Patients were randomized 1:1 to receive either belantamab mafodotin (2.5mg/kg intravenously every three weeks) plus 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.
"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," said Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK. "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."
Implications for Multiple Myeloma Treatment
Multiple myeloma, the third most common blood cancer globally, affects over 180,000 individuals each year. While treatable, it is not typically curable, and patients often become refractory to available treatments. The results of the DREAMM-7 trial offer a potential new treatment option for patients with relapsed/refractory disease.
The DREAMM clinical development program continues to evaluate belantamab mafodotin in earlier lines of treatment and in combination with other therapies. This includes the ongoing DREAMM-8 trial, which is evaluating belantamab mafodotin in combination with pomalidomide and dexamethasone versus bortezomib in combination with pomalidomide and dexamethasone.
Regulatory Plans and Further Data
GSK plans to share the DREAMM-7 data with health authorities to support regulatory filings. Full results, including safety data, will be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition on December 9, 2024. Belantamab mafodotin combinations have already been filed in the US, European Union, Japan, United Kingdom, Canada, and Switzerland based on DREAMM-7 and DREAMM-8 trial results. The National Medical Products Administration in China has granted Breakthrough Therapy Designation and priority review for belantamab mafodotin in combination with BorDex, based on DREAMM-7 results.
