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.
Dr Sagar Lonial, MD, Chief Medical Officer, Winship Cancer Institute of Emory University, Chair of Emory Department of Hematology and Medical Oncology and Principal Investigator for DREAMM-2, said: "Each day in my practice, I see patients who would benefit from additional therapeutic options because their disease has advanced and is no longer responding to available treatments. In recent years, BCMA has become one of the most promising targets in multiple myeloma research. The data published today from DREAMM-2 not only reinforce the significance of BCMA as a potentially viable target, but also underscore the potential of belantamab mafodotin, if approved, as a practical treatment option in this patient population."
The results demonstrated in DREAMM-2 were consistent with those observed in a similar subset of patients in the DREAMM-1 study. Based on these data, GSK is moving forward with a US FDA submission seeking approval of the 2.5 mg/kg dose. If approved, belantamab mafodotin will be the first anti-BCMA agent available in the US.
Thirty of the 97 patients (31%) in the 2.5 mg/kg cohort achieved an overall response. Of these responders, 18 patients achieved a very good partial response or better, including three patients with stringent complete or complete responses. In addition, overall survival in patients achieving a response was not reached in the six month follow-up period.
The safety and tolerability profile was consistent with previously reported data on belantamab mafodotin. The three most commonly reported Grade 3 or 4 adverse events in the 2.5 mg/kg arm were keratopathy (27%), thrombocytopenia (20%) and anaemia (20%). Keratopathy is characterized as changes in the corneal epithelium as seen on eye examination which can manifest with or without symptoms. Corneal events leading to treatment discontinuation affected 1% of patients in the 2.5 mg/kg cohort.
Additional studies are testing the effect of belantamab mafodotin as third-line monotherapy in relapsed/refractory multiple myeloma and in combination with standard and novel treatments in the first and second line setting as part of the broader DREAMM clinical development programme.
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