The addition of daratumumab (Darzalex; Johnson & Johnson) to lenalidomide and dexamethasone (D-Rd) resulted in a significant benefit to overall survival (OS) in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for autologous stem cell transplant (ASCT) and were treated to progression when compared to lenalidomide and dexamethasone (Rd) alone, according to the results of the phase 3 MAIA study.
“The treatment of multiple myeloma becomes more complex with each relapse,” said Thierry Facon, MD, professor of hematology at Lille University Hospital in France, in a press release. “Therefore, it is critical to achieve deep treatment responses and improved survival with frontline therapy. These results strongly support the use of daratumumab, lenalidomide and dexamethasone as a new standard of care to extend survival and improve clinical outcomes in transplant ineligible patients with newly diagnosed multiple myeloma.”
A total of 737 patients were enrolled in the MAIA study, all of whom were diagnosed with NDMM and were ineligible for high-dose chemotherapy and ASCT. The patients were split into 2 treatment arms: 1 receiving a 28-day cycle of D-Rd (n=368), and the other receiving a 28-day cycle of Rd (n=369). Patient age ranged from 45 to 90 years, with a median age of 73 years.
After a median follow-up of over 56 months, the risk of death was observed to be 32% lower in the D-Rd treatment arm when compared to the Rd arm. Progression-free survival (PFS) also improved for the patients in the D-Rd arm, with a 47% decrease in the risk of disease progression or death. Neither median OS nor median PFS were reached in either arm.
“These latest findings from the MAIA study demonstrate the impact of this [daratumumab] combination regimen on long-term survival in the frontline setting, further establishing the importance of [daratumumab] as a backbone therapy in the treatment of multiple myeloma,” said Craig Tendler, MD, in the press release. “These results provide hope and confidence for newly diagnosed patients with multiple myeloma seeking effective treatment regimens that improve long-term outcomes and reflect our commitment to continuing to explore the full potential of [daratumumab] in multiple myeloma.”
The study did not identify any new safety concerns for the D-Rd arm. The most common grade 3 or 4 treatment-emergent adverse events were neutropenia, pneumonia, anemia, and lymphopenia.
Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible [news release]. Johnson & Johnson; June 12, 2021. Accessed June 15, 2021. https://www.jnj.com/janssen-announces-results-from-phase-3-maia-study-showing-significant-overall-survival-benefits-for-treatment-with-darzalex-daratumumab-in-patients-with-newly-diagnosed-multiple-myeloma-who-are-transplant-ineligible