GlaxoSmithKline announced Friday that a pivotal study of the experimental drug belantamab mafodotin in patients with relapsed/refractory multiple myeloma met its primary objective, demonstrating a clinically meaningful overall response rate (ORR). The company said that results from the DREAMM-2 trial will form the basis of regulatory filings starting later this year.
Belantamab mafodotin, also known as GSK2857916, is an immuno-conjugate comprising a humanised anti-BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seattle Genetics, while the monoclonal antibody is produced using technology licensed from BioWa.
Earlier this year, GlaxoSmithKline reported  updated results from the DREAMM-1 study confirming that belantamab mafodotin was associated with an ORR of 60% in patients with relapsed or refractory multiple myeloma. Further data showed that in heavily pre-treated patients who were not previously treated with Johnson & Johnson's Darzalex (daratumumab), the ORR was 71%.
The DREAMM-2 study included 196 patients with relapsed multiple myeloma, who were refractory to an immunomodulatory drug, a proteasome inhibitor, and to treatment with an anti-CD38 antibody, and investigated two doses of belantamab mafodotin. GlaxoSmithKline noted that further results from the trial will be presented at an upcoming medical meeting.
Hal Barron, president of R&D at GlaxoSmithKline, said "I am pleased with the results of the DREAMM-2 study and excited about what these data could mean for patients with multiple myeloma who have exhausted other lines of treatment." The company also plans to investigate belantamab mafodotin in a number of Phase III studies, including a trial comparing the therapy to pomalidomide plus low-dose dexamethasone and another versus Darzalex.