Long-term outcomes from MAIA support the use of daratumumab plus lenalidomide and dexamethasone for ≥18 months in newly diagnosed, transplant ineligible MM patients.
Data from the phase 3 MAIA study, which assessed daratumumab plus lenalidomide and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) alone in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplant, demonstrated improved progression-free survival (PFS) and overall survival (OS) with D-Rd treatment until progression. Given the high cost of D-Rd treatment, long-term safety and efficacy/clinical benefit are important considerations for physicians and payers. A post hoc analysis of OS and PFS data from MAIA was conducted to determine the impact of treatment duration on long-term clinical outcomes.
A post hoc OS analysis was conducted in patients who received D-Rd for ≥18 months. To determine the impact of discontinuing individual regimen components, an analysis was also performed in D-Rd patients who discontinued D or R+/-d but continued remaining treatment. An additional post hoc analysis was performed in patients who received D-Rd or Rd for ≥9 or ≥18 months to assess the impact of treatment duration on PFS and OS.
After a median follow-up of 56.2 months, there was an OS benefit in patients receiving D-Rd for ≥18 months versus patients who received D-Rd <18 months (hazard ratio [HR], 0.16; 95% confidence interval [CI], 0.1-0.25; P <.0001). There were 48 D-Rd patients who discontinued R+/-d but continued D+/-d; the 60-month PFS and OS rates among this population were 97.9% and 100%, respectively, compared with 52.5% and 66.3% in the overall study population. In patients receiving treatment for ≥18 months, there was a PFS (HR, 0.57; 95% CI, 0.43-0.76; P <.0001) and OS benefit (HR, 0.68; 95% CI, 0.47- 0.98; P = .0379) of D-Rd versus Rd. In this group of patients, responses deepened over time; the rate of complete response or better was 9.2% by 6 months, 19.1% by 9 months, and 49.8% by 18 months. There was also a PFS and OS benefit with D-Rd versus Rd in patients receiving treatment for ≥9 months (PFS HR, 0.49; 95% CI, 0.38-0.62; P <.0001; OS HR, 0.63; 95% CI, 0.47-0.85; P = .0025). There were no new safety signals, and grade 3/4 hematologic treatment-emergent adverse events with D-Rd decreased over time.
Findings from this analysis support D-Rd treatment for at least 18 months to achieve deep clinical responses, with demonstrated improvement in clinical outcomes with D-Rd treatment versus Rd alone in patients receiving ≥18 months of treatment.
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