GSK Korea said that treatment with the investigational single-agent belantamab mafodotin resulted in a clinically meaningful 31 percent overall response rate (ORR) with the 2.5 mg/kg regimen in patients with heavily pre-treated multiple myeloma.
Patients in the trial, known as DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma), received a median of seven prior lines of treatment. They 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.
GSK also submitted a biologics license application to the U.S. 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.
The treatment is currently not approved for use anywhere in the world.
“Patients with multiple myeloma whose disease has progressed despite currently available therapy have limited options and poor outcomes,” GSK’s Chief Scientific Officer and President of R&D Hal Barron said. “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 humanized, immunoconjugate against B-cell maturation antigen (BCMA).
Patients in the trial had active, progressing multiple myeloma, which had worsened despite the current standard of care and was randomized 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.
“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,” said Professor Sagar Lonial, the principal investigator for DREAMM-2. “In recent years, BCMA has become one of the most promising targets in multiple myeloma research.”
The data published 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, Lonial added.
Full results from the DREAMM-2 study were published in The Lancet Oncology on Dec. 16.
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