During the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 569), Salomon Manier, MD, PhD, of Lille University Hospital, France, and colleagues presented efficacy and safety data from the phase III IFM2017-03 trial of the monoclonal antibody daratumumab plus lenalidomide in frail patients with multiple myeloma. According to the investigators, this dexamethasone-sparing regimen demonstrated rapid and deep responses, with a favorable safety profile.

This study enrolled 295 patients (with a median age of 81) who had newly diagnosed multiple myeloma. Participants were randomly assigned to receive 28-day cycles of lenalidomide and dexamethasone (n = 95) or daratumumab (n = 200), lenalidomide, and two cycles of dexamethasone. Treatment was continued until unacceptable toxicity or disease progression.

The baseline demographics and disease characteristics were reported to be well balanced between the groups. The overall response rate among patients given daratumumab (89%) was significantly higher than that of those given dexamethasone (77%; P = .025). In comparison, the 12-month rate of a very good partial response or better was 58% in the daratumumab arm and 42% in the dexamethasone arm; the depth of response improved during treatment. The median time to achievement of a very good partial response or better was 11 months in the dexamethasone group and 5 months in the daratumumab group.

At least one adverse event of grade 3 or higher was reported during the first treatment year in 76% and 64% of patients in the daratumumab and no-daratumumab groups, respectively. Of note, individuals receiving daratumumab experienced more grade 3 or higher hematologic events such as anemia and neutropenia, although similar rates of infections were reported between both groups. Rates of treatment discontinuation were also similar in both treatment arms (16% vs. 13%).

Source: ASH