Daratumumab, in combination with lenalidomide and dexamethasone, may have more benefits compared with lenalidomide and dexamethasone alone for the treatment of newly diagnosed multiple myeloma (MM) patients who are not candidates for high-dose chemotherapy and autologous stem cell transplant (ASCT), according to interim results from a phase 3 study.1
The study met the primary end point of improving progression-free survival (PFS) at a preplanned interim analysis (hazard ratio [HR], 0.55) resulting in a 45% reduction in the risk of progression or death in patients treated with daratumumab in combination with lenalidomide and dexamethasone. The median PFS for patients treated with the combination therapy had not been reached at the time of analysis, compared with an estimated median PFS of 31.9 months for patients who received lenalidomide and dexamethasone alone.
The researchers reported that no unexpected side effects were seen in this study. Overall, the safety profile of the daratumumab-based combination was consistent with the known safety profiles associated with each drug alone. This is 1 of several studies that has shown that the addition of daratumumab to standard of care in MM may be beneficial.
The phase 3 MAIA study (ClinicalTrials.gov Identifier: NCT02252172) is a randomized, open-label, multicenter study that includes 737 newly diagnosed patients with MM who are not candidates for high-dose chemotherapy and ASCT. Genmab A/S from Copenhagen, Denmark announced the study (MMY3008) results and said it plans to pursue talks with federal regulators to prepare for regulatory filings.
- Genmab announces positive topline results in phase 3 MAIA study of daratumumab in front line multiple myeloma [press release]. https://ir.genmab.com/news-releases/news-release-details/genmab-announces-positive-topline-results-phase-iii-maia-study. Published October 29, 2018. Accessed November 7, 2018.