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.
To sign up for our newsletter or print publications, please enter your contact information below.
Subscribe to recieve the free, monthly TON print publication and TON weekly e‑newsletter.