Phase III Trial Supports Efficacy of Subcutaneous Daratumumab in Relapsed/Refractory Myeloma

This article was originally published on Ash Clinical News

Patients with relapsed/refractory multiple myeloma (MM) who were treated with a combination of subcutaneous daratumumab plus pomalidomide-dexamethasone (Pd) had a 37% lower risk of disease progression or death, compared with those who received Pd alone, according to results from the phase III APOLLO trial. Meletios Dimopoulos, MD, from the National and Kapodistrian University of Athens in Greece, presented these results during the 2020 ASH Annual Meeting.

“This is the first prospective randomized trial where the anti-CD38 monoclonal antibody daratumumab was administered subcutaneously in combination with a standard anti-myeloma regimen such as pomalidomide and low-dose dexamathesone,” explained Dr. Dimopoulos. (Previous randomized studies used the intravenous formulation of daratumumab.) “This trial is likely to lead to the approval [of subcutaneous daratumumab plus Pd] by regulatory authorities in Europe for patients whose disease is progressing after treatment with lenalidomide and bortezomib.”

In the U.S., the combination of Pd and intravenous daratumumab is approved as a second-line therapy for patients with MM who have received two or more prior lines of therapy, including lenalidomide and a proteasome inhibitor. However, intravenous administration typically requires patients to spend a full day at the clinic for each infusion.

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