GSK reports positive data from DREAMM-2 multiple myeloma trial

17th December 2019 (Last Updated December 17th, 2019 11:52)

GlaxoSmithKline (GSK) has reported positive results from the open-label DREAMM-2 clinical trial of belantamab mafodotin in patients with multiple myeloma.

GSK reports positive data from DREAMM-2 multiple myeloma trial
GSK submitted an application to the US Food and Drug Administration (FDA) seeking approval for belantamab mafodotin. Credit: GSK.

GlaxoSmithKline (GSK) has reported positive results from the open-label DREAMM-2 clinical trial of belantamab mafodotin in patients with multiple myeloma.

Belantamab mafodotin is a humanised immunoconjugate that targets B-cell maturation antigen (BCMA).

DREAMM-2 evaluated 2.5mg/kg and 3.4mg/kg every three weeks in heavily pre-treated patients with actively progressing multiple myeloma even after treatment with the current standard of care.

The trial enrolled patients who had a median of seven previous lines of therapy, were refractory to an immunomodulatory medicine and a proteasome inhibitor, and were refractory and/or intolerant to an anti-CD38 antibody.

Participants experienced a 31% overall response rate (ORR) with the 2.5mg/kg regimen. The company also reported that overall survival in subjects with a response was not reached in the six month follow-up period.

The safety and tolerability profile of the drug was consistent with previous findings. The most common Grade 3 or 4 adverse events relating to the 2.5mg/kg dose were keratopathy, thrombocytopenia and anaemia.

GSK chief scientific officer and R&D president Dr Hal Barron said: “Patients with multiple myeloma whose disease has progressed despite currently available therapy have limited options and poor outcomes.

“Data from the DREAMM-2 study show that, if approved, belantamab mafodotin could offer an important new treatment option for these patients.”

The company submitted a biologics license application to the US Food and Drug Administration (FDA) for the approval of 2.5mg/kg belantamab mafodotin to treat relapsed or refractory multiple myeloma patients who previously received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

If approved, the drug is expected to be the anti-BCMA agent accessible in the US.

GSK is also studying the drug as third-line monotherapy in relapsed/refractory multiple myeloma, as well as in combination with standard and new therapies in the first and second line setting.