|The following article features coverage from the European Hematology Association (EHA) 2021 Virtual Congress. Click here to read more of Hematology Advisor‘s conference coverage.|
Among patients with newly diagnosed, transplant-ineligible multiple myeloma (MM), adding daratumumab (D) to a lenalidomide/dexamethasone (Rd) combination regimen reduces the risk of death by up to 32%, according to long-term follow-up data presented at the European Hematology Association (EHA) 2021 Virtual Congress.
Previous phase 3 research found the addition of D to standard regimens received by patients with newly diagnosed MM led to superior clinical outcomes. Primary analysis of the randomized phase 3 MAIA trial (ClinicalTrials.gov Identifier: NCT02252172) suggested that a D-Rd combination may be superior for reducing the risk of death compared with Rd alone.
In this presentation, the authors presented long-term follow-up data from MAIA in a cohort of transplant-ineligible patients.
All patients enrolled in the MAIA trial were ineligible for high-dose chemotherapy and stem cell transplantation; patients were randomly assigned 1:1 to receive D-Rd or Rd alone. The study’s primary endpoint was progression-free survival; secondary endpoints included overall response rate, overall survival (OS), and safety.
In total, 737 patients were randomly assigned to D-Rd (383 patients) or Rd (369 patients). The median patient age was 73 years (range, 45-90).
After a median follow-up of 56.2 months, analysis suggested that D-Rd reduces the risk of death by 32% compared with Rd. Median OS was not reached in either arm (hazard ratio [HR], 0.68; P = .0013), and the estimated 5-year OS rates were 66.3% and 53.1% in the D-Rd and Rd groups, respectively.
The median progression-free survival was not reached in the D-Rd group vs 34.4 months in the Rd group (HR, 0.53; P < .0001); the overall response rates were 92.9% vs 81.6%, respectively (P < .0001).
The most common grade 3 to 4 adverse events occurring in more than 15% of patients in the D-Rd vs Rd groups were neutropenia (54.1% vs 37%, respectively), pneumonia (19.2% vs 10.7%), anemia (16.8% vs 21.6%), and lymphopenia (16.5% vs 11.2%).
Disclosure: The presenter declared affiliations with Janssen, Bristol Myers Squibb, Takeda, Sanofi, Roche, Karyopharm, Oncopeptides, and Amgen.
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Facon T, Kumar SK, Plesner T, et al. Overall survival results with daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: phase 3 MAIA study. Paper presented at: European Hematology Association 2021 Virtual Congress; June 2021; Abstract LB1901.
This article originally appeared on Cancer Therapy Advisor