GSK plc (NYSE:GSK) announced interim results from the DREAMM-7 Phase 3 trial evaluating Blenrep (belantamab mafodotin) combined with bortezomib and dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma. The trial demonstrated a significant reduction in the risk of death for the Blenrep-BorDex combination compared to the standard of care, daratumumab with BorDex, meeting the key secondary endpoint of overall survival (OS). Detailed findings, including safety data, will be presented at the upcoming American Society of Hematology Annual Meeting.
A Phase 3 study targeting newly diagnosed, transplant-ineligible multiple myeloma patients is expected to start by late 2024 under the DREAMM program. Regulatory filings for Blenrep combinations in relapsed or refractory multiple myeloma, supported by results from DREAMM-7 and DREAMM-8 trials, are underway in the U.S., EU, Japan, UK, Canada, and Switzerland.
In 2022, GSK withdrew Blenrep's U.S. marketing authorization after the DREAMM-3 Phase 3 trial failed to meet FDA Accelerated Approval requirements. However, interim DREAMM-8 results released in June showed Blenrep with pomalidomide and dexamethasone significantly improved progression-free survival compared to bortezomib with pomalidomide and dexamethasone, further bolstering the drug's clinical profile.