Blenrep in Combination Announces Breakthrough Therapy Designation for Relapsed/Refractory Multiple Myeloma Treatment
GSK has announced that National Medical Products Administration (NMPA) Center for Drug Evaluation has granted Breakthrough Therapy Designation (BTD) for Blenrep (belantamab mafodotin), in combination with bortezomib and dexamethasone (BorDex), for treating relapsed or refractory multiple myeloma.
The BTD aims to speed up the development of treatments for serious diseases where no current therapies exist or where there is evidence of improved patient outcomes compared to existing options.
The designation is based on interim findings from the phase III DREAMM-7 trial, which showed notable improvements in progression-free survival (PFS) for patients with relapsed or refractory multiple myeloma treated with Blenrep and BorDex, compared to those receiving a combination of daratumumab and BorDex.
While a positive trend in overall survival (OS) was noted, it did not reach statistical significance during the interim analysis. Furthermore, the trial demonstrated improved response rates regarding the depth and duration of response compared to the existing standard treatment. The safety profile of Blenrep observed in the trial was in line with previously reported data for the individual components.
About DREAMM-7
DREAMM-7 is a phase III clinical trial that evaluates the safety and efficacy of Blenrep in combination with BorDex, compared to daratumumab with BorDex, in patients who have previously undergone at least one line of therapy for relapsed or refractory multiple myeloma.
The trial's primary endpoint is progression-free survival, while key secondary endpoints include overall survival, duration of response, and minimal residual disease negativity. Additional secondary measures assess overall response rate, safety, and patient-reported outcomes on quality of life.
