GlaxoSmithKline, a UK-based pharmaceutical company recently announced treatment of patients with heavily pre-treated multiple myeloma with belantamab mafodotin, an investigational agent. The study resulted in a clinically meaningful 31% ORR (overall response rate) with a 2.5 mg/kg regimen in the patients.
For the record, Multiple myeloma is one of the most common blood cancers, which is usually considered treatable, but not curable. The disease commonly becomes relapsed/refractory to available treatments, prompting the need for research into new therapies for potential treatment.
The complete result from the pivotal study DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) of belantamab mafodotin (GSK2857916) was published recently in The Lancet Oncology. GlaxoSmithKline has also confirmed the submission of a Biologics License Application to the US FDA, seeking approval of the investigational for the treatment of patients with refractory/relapsed multiple myeloma, which were earlier treated with an anti-CD38 antibody, an immunomodulatory agent and a proteasome. Currently, Belantamab mafodotin is not approved for use anywhere in the world.
As observed in a set of patients in the DREAMM-1 study, the results demonstrated in DREAMM-2 were also consistent. Based on the data, GlaxoSmithKline is expected to seek approval of the 2.5 mg/kg dose. If the submission is approved, belantamab mafodotin will become the first anti-BCMA (B-cell maturation antigen) agent available in the US.
In the study, 30 of the 97 patients in the 2.5 mg/kg cohort achieved an ORR. Out of these, 18 patients attained a very good partial response, including three patients with a complete response.
Dr Hal Barron, CSO and President Research & Development, GlaxoSmithKline was reportedly quoted saying that patients with multiple myeloma whose disease has progressed negatively despite the currently available therapies, are left with limited options. The data from the recent study shows that, if approved, the investigational belantamab mafodotin is likely to offer a significant new treatment option for these patients.
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