- Overall response rate (ORR) of 31% with 2.5 mg/kg regimen and no new safety signals in heavily pre-treated patient population who were refractory to an immunomodulatory drug and a proteasome inhibitor, and were refractory or intolerant to an anti-CD38 antibody
- Data published in The Lancet Oncology highlight the potential of belantamab mafodotin for patients with multiple myeloma whose disease has progressed
- GSK confirms submission of a Biologics License Application to the US Food and Drug Administration
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced treatment with the investigational single-agent belantamab mafodotin resulted in a clinically meaningful 31% overall response rate (ORR) with the 2.5 mg/kg regimen in patients with heavily pre-treated multiple myeloma. Patients in the trial received a median of seven prior lines of treatment, were refractory to an immunomodulatory drug and a proteasome inhibitor and were refractory and/or intolerant to an anti-CD38 antibody. The median duration of response has not been reached at six months of follow-up.
Full results from the DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study of belantamab mafodotin were published today in The Lancet Oncology. GSK also confirmed submission of a Biologics License Application to the US Food and Drug Administration (FDA) seeking approval of belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Belantamab mafodotin is not currently approved for use anywhere in the world.
Dr Hal Barron, Chief Scientific Officer and President R&D, GSK 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.”
DREAMM-2 is an open label study of belantamab mafodotin, a humanised, immunoconjugate against B-cell maturation antigen (BCMA).i Patients in the trial had actively progressing multiple myeloma that had worsened despite current standard of care and were randomised to two arms to receive either 2.5 mg/kg or 3.4 mg/kg belantamab mafodotin every three weeks. Overall, patients in DREAMM-2 had more advanced disease, poorer prognosis and performance status and also had a greater number of prior lines of therapy in comparison with patients in DREAMM-1, the first time in human study of belantamab mafodotin.
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