Daratumumab plus lenalidomide and dexamethasone shows improvement in progression-free survival in patients with newly diagnosed multiple myeloma, according to interim results published in The Lancet Oncology.

MAIA is a randomized, phase 3, open-label trial with patients across 176 hospitals in 14 countries. A total of 737 patients with newly diagnosed, transplant-ineligible multiple myeloma were assigned to receive daratumumab plus lenalidomide and dexamethasone (n=368) or to a control group, which received lenalidomide and dexamethasone only (n=369).

As of the analysis cutoff date, 99% of patients in both groups had received at least 1 dose of the study treatment. A total of 209 (57%) patients in the daratumumab and 298 (81%) patients in the control group had discontinued treatment, most commonly because of adverse events and disease progression.

The daratumumab group had a median duration of study treatment of 47.5 months and the control group had a median duration of 22.6 months.

After about 56 months of follow-up, median progression-free survival (PFS) was significantly improved for the daratumumab group compared to the control group (P <.0001). The median PFS was not reached in the daratumumab group compared with 34.4 months in the control group.

At follow-up, 48 patients in the daratumumab group died and 112 had disease progression. A total of 46 patients in the control group died and 171 had disease progression. The Kaplan-Meier estimated 60-month PFS was 52.5% in the daratumumab group and 28.7% in the control group.

Neither group reached a median overall survival as of the interim analysis. The post hoc Kaplan-Meier estimated 60-month overall survival was 66.3% for the daratumumab group and 53.1% for the control group.

The study authors found no new safety events. The most common grade 3 treatment-emergent adverse events (TEAEs) were neutropenia, pneumonia, anemia, and lymphopenia. Patients in the daratumumab group more frequently reported grade 3 or higher TEAEs and infections.

The proportion of patients who had a complete response or better increased from 48% to 51% from the primary analysis to the current analysis.

Overall, daratumumab conferred an overall survival and PFS benefit for patients with newly diagnosed transplant-ineligible multiple myeloma.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

References:

https://www.hematologyadvisor.com/home/topics/myeloma/multiple-myeloma-daratumumab-lenalidomide-dex-survival-benefit-treatment/