Adding daratumumab to lenalidomide and dexamethasone significantly prolonged progression-free survival compared with lenalidomide plus dexamethasone alone in patients with relapsed or refractory multiple myeloma, a study published in The New England Journal of Medicine has shown.1
Because this daratumumab in combination with lenalidomide and dexamethasone demonstrated promising activity in a phase 1/2 trial, researchers sought to evaluate the efficacy and safety of the combination in a phase 3 trial.
For the open-label, POLLUX study (A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma; ClinicalTrials.gov Identifier: NCT02076009), investigators enrolled 569 patients with multiple myeloma who had received at least 1 prior line of therapy. Participants were randomly assigned to receive lenalidomide and dexamethasone with or without daratumumab.
At a median follow-up of 13.5 months, results showed that treatment with daratumumab was associated with 63% reduction in the risk of progression or death compared with lenalidomide plus dexamethasone alone (hazard ratio [HR], 0.37; 95% CI, 0.27-0.52; P <.001). The 12-month progression-free survival rates were 83.2% (95% CI, 78.3-87.2) in the daratumumab group vs 60.1% (95% CI, 54.0-65.7) in the control arm.
Researchers also found that significantly more daratumumab-treated patients achieved an overall response and a complete response or better (P <.001).
The most common grade 3 to 4 treatment-related adverse events in the daratumumab arm were neutropenia, thrombocytopenia, anemia. Daratumumab was associated with a higher rate of neutropenia vs the control arm.
Of note, nearly half of patients who received daratumumab experienced infusion-related reactions, which were mostly of grade 1 to 2 severity.
1. Dimopoulos MA, Oriol A, Nahi H, et al. Daratumumab, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375:1319-1331.