On January 22, GSK registered aBelantamab mafodotin(Maberalimab)In combination with lenalidomide and dexamethasone（BRd）Head-to-Head Daratumumab in Combination with Lenalidomide and Dexamethasone（DRd）First-line treatment for multiple myelomaThe Phase III DREAMM-10 Study.
Source:Official Website of Drug Clinical Trial Registration and Information Disclosure PlatformDREAMM-10 is a randomized, parallel-group, open-label international multicenter Phase III clinical trial designed to evaluate BRd versus DRd inNewly Diagnosed Multiple Myeloma Unsuitable for Autologous Stem Cell Transplant（ TI-NDMM ）Efficacy and safety in subjects. A total of 165 institutions globally are participating, with plans to enroll 80 subjects in China and 520 subjects internationally. The primary endpoint is progression-free survival.（PFS）、MRD-negative status.Belantamab mafodotin is aAntibody-Drug Conjugates (ADC) Targeting BCMAIn August 2020, based on the results of the pivotal Phase II clinical DREAMM-2 study, the drug received accelerated approval from the FDA and conditional approval from the EMA for marketing. It was approved as a monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma, becoming the world's first approved BCMA ADC.However, due to the Phase III DREAMM-3 study not meeting its primary endpoint of PFS, GSK voluntarily withdrew the U.S. marketing application for Belantamab mafodotin in November 2022. In April 2024, the EU also withdrew the marketing authorization for Belantamab mafodotin.Although the initial market launch was not smooth, studies show that Belantamab mafodotin can still benefit some patients with multiple myeloma. In November 2024, GSK announcedBelantamab Mafodotin in Combination with Bortezomib and Dexamethasone（BorDex）Interim Analysis of Phase III DREAMM-7 Study Shows Positive Results for Head-to-Head Comparison of Daratumumab Combined with BorDex as Second-Line Treatment for Relapsed or Refractory Multiple Myeloma, reaching the overall survival period（OS）The key secondary endpoint.GSK has successively submitted the marketing application for Belantamab mafodotin as a second-line treatment for multiple myeloma to regulatory authorities such as NMPA, FDA, and EMA.Cover Source:Corporate Logo
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