Long-Term Follow-Up Data Support Adding Daratumumab to Lenalidomide/Dexamethasone in Transplant-Ineligible MM

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.

Reference

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