Daratumumab demonstrated a clinically meaningful and significant benefit compared with active monitoring, the current standard of care, for patients with high-risk smoldering multiple myeloma (SMM), according to results from the Aquila phase 3 randomized study.
The results were presented at the 66th American Society of Hematology Annual Meeting and Exposition in San Diego, California.
Patients in the study (n=390) were randomized 1:1 to receive active monitoring subcutaneous daratumumab, a human immunoglobulin G kappa (IgGκ) monoclonal antibody targeting CD38, versus The primary endpoint was progression-free survival (PFS), defined as progression to active MM as assessed by an independent review committee and according to International Myeloma Working Group diagnostic criteria for MM (SLiM-CRAB) or death.
At a median (range) follow-up of 65.2 (0-76.6) months, PFS was significantly improved with daratumumab versus active monitoring (HR, 0.49; P<0.0001). The overall response rate was 63.4% with daratumumab versus 2.0% with active monitoring (P<0.0001). As of the clinical cutoff, 64 (33.0%) patients in the daratumumab group and 102 (52.0%) patients in the active monitoring group had started first-line MM treatment. A total of 41 deaths were observed, 15 for the daratumumab group and 26 for the active monitoring group.
In terms of safety, grade 3 or 4 treatment-emergent adverse events occurred in 40.4% and 30.1% of patients in the daratumumab and active monitoring groups, respectively.
“Daratumumab monotherapy was well tolerated and demonstrated a clinically meaningful and significant benefit in preventing or delaying progression to active MM compared with active monitoring in patients with high-risk SMM,” the authors wrote. “These results strongly support the benefit of early intervention with daratumumab monotherapy versus active monitoring, the current standard of care, in patients with high-risk SMM.”
Reference
Dimopoulos MA, Voorhees P, Schjesvold F. Phase 3 randomized study of daratumumab monotherapy versus active monitoring in patients with high-risk smoldering multiple myeloma: primary results of the aquila study. Abstract #773; 66th American Society of Hematology Annual Meeting and Exposition; December 7-10; San Diego, California.
