|The following article features coverage from the 2021 Annual Meeting of the Society of Hematologic Oncology (SOHO). Click here to read more of Hematology Advisor‘s conference coverage.|
In a nearly 5-year follow-up of a phase 3 study, patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM) reportedly experienced a significant overall survival (OS) benefit with daratumumab added to lenalidomide and dexamethasone (D-Rd). Study results were presented at the Annual Meeting of the Society of Hematologic Oncology (SOHO) by Robert Z. Orlowski, MD, PhD, of The University of Texas MD Anderson Cancer Center in Houston, TX, and colleagues.
The phase 3 MAIA study (ClinicalTrials.gov Identifier: NCT02252172) evaluated the combination of D-Rd in comparison with lenalidomide and dexamethasone (Rd) only for treatment of transplant-ineligible NDMM. Patients were randomized 1:1 between the 2 treatment arms, with both arms receiving treatment until progressive disease. The primary study endpoint was progression-free survival (PFS). In their poster, Dr Orlowski and colleagues presented updated efficacy and safety results after a median of 56.2 months in this study, with an emphasis on OS.
For efficacy analyses, the D-Rd arm contained 368 patients, and the Rd arm had 369 patients. Patients had a median baseline age of 73.0 years in the D-Rd arm and 74.0 years in the Rd arm. Of patients in the D-Rd arm, 43% were 75 or more years of age at baseline, and 44% were in this age group in the Rd arm.
At this follow-up, 42% of patients in the D-Rd population remained on study treatment, compared with 18% in the Rd arm. The 60-month OS rate was 66.3% for the D-Rd arm, and it was 53.1% for the Rd arm, with median OS not reached in either group. D-Rd was associated with a 32% reduction in the risk of death, compared with Rd in this population (hazard ratio [HR], 0.68; 95% CI, 0.53-0.86; P =.0013). OS benefits with D-Rd were reportedly consistent throughout patient subgroups.
The 60-month PFS rates were 52.5% with D-Rd and 28.7% with Rd, suggesting a 47% reduction in risk of disease progression or death with D-Rd (HR, 0.53; 95% CI, 0.43-0.66; P <.0001). The median PFS was not reached for D-Rd group, and it was 34.4 months for the Rd group. The 56.2-month overall response rates were 93% with D-Rd and 82% with Rd, including stringent complete response rates of 35% with D-Rd and 15% with Rd.
Safety analyses included 364 patients in the D-Rd arm and 365 patients in the Rd arm. Reportedly, no new safety concerns were found with extended follow-up. For both treatment arms, grade 3 to 4 and serious treatment-emergent adverse events were reported to occur at lower rates after 24 months, compared with the first 24 months of the study.
The study investigators concluded that the results of this study provide strong support for the use of D-Rd as initial therapy as a new standard-of-care in treatment of transplant-ineligible NDMM.
Disclosures: Some authors have declared affiliations with or received grant support from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.
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Orlowski RZ, Facon T, Kumar SK, et al. Phase 3 MAIA study: overall survival results with daratumumab, lenalidomide, and dexamethasone vs lenalidomide and dexamethasone in patients with transplant-ineligible newly diagnosed multiple myeloma. Paper presented at: Annual Meeting of the Society of Hematologic Oncology (SOHO); September 8-11, 2021. Abstract MM-155.