Maintenance combination extends PFS in newly diagnosed multiple myeloma
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Key takeaways:
- Patients had a reduced risk for disease progression or death when treated with daratumumab-lenalidomide vs. lenalidomide alone.
- The combination appeared associated with higher incidence of cytopenias.
The addition of daratumumab to maintenance lenalidomide extended PFS for patients who underwent stem cell transplant for newly diagnosed multiple myeloma, according to study results.
The combination reduced risk for disease progression or death by 47% compared with lenalidomide alone, results of the randomized phase 3 AURIGA trial showed.
“This is a practice-informing trial that supports the addition of daratumumab not only in induction/consolidation, but also in maintenance,” Ashraf Z. Badros, MBCHB, director of the multiple myeloma service at University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, told Healio. “The trial also supports the use of minimal residual disease as a surrogate endpoint in multiple myeloma trials.”
No randomized trial had assessed the addition of daratumumab (Darzalex, Janssen) to standard maintenance therapy with lenalidomide for patients with newly diagnosed multiple myeloma who underwent transplant.
In the AURIGA trial, researchers evaluated daratumumab-lenalidomide maintenance vs. lenalidomide alone.
Eligible participants achieved at least a very good partial response and had to be minimal residual disease (MRD)-positive and anti-CD38 naive after transplant.
Researchers randomly assigned 200 patients to daratumumab-lenalidomide maintenance (n = 99) lenalidomide alone (n = 101).
MRD-negative conversion rate by 12 months from start of maintenance served as the primary endpoint.
Patients assigned the combination had a higher MRD-negative conversion rate by 12 months than those treated with lenalidomide alone (50.5% vs. 18.8%; OR = 4.51; 95% CI, 2.37-8.57).
After median follow-up of 32.3 months, the MRD-negative conversion rate (60.6% vs. 27.7%; OR = 4.12; 95% CI, 2.26-7.52), as well as the rate of complete response or better (75.8% vs. 61.4%; OR = 2; 95% CI, 1.08-3.69) was higher in the combination group.
Thirty-month PFS also favored the combination (82.7% vs 66.4%; HR = 0.53; 95% CI, 0.29-0.97).
Grade 3/grade 4 cytopenias (54.2% vs. 46.9%) and infections (18.8% vs. 13.3%) occurred more frequently in the combination group.
"The significant improvement in MRD-negative conversion rates and the promising progression-free survival data suggest that this maintenance regimen has the potential to improve longer-term outcomes for patients with newly diagnosed multiple myeloma who are transplant eligible,” Badros said in a press release. “Combining daratumumab with lenalidomide in the maintenance setting offers an advantage over lenalidomide alone for several clinically relevant subgroups that include elderly patients, those with high-risk disease and high tumor burden who are newly diagnosed with multiple myeloma.”
References:
- Badros AZ, et al. Blood. 2024;doi:10.1182/blood.2024025746.
- Early results from multiple myeloma clinical trial prove cancer drug combination provides longer response and potential benefit in disease-free survival (press release). Available at: https://www.medschool.umaryland.edu/news/2024/early-results-from-multiple-myeloma-clinical-trial-prove-cancer-drug-combination-provides-longer-response-and-potential-benefit-in-disease-free-survival-.html. Published Oct. 2, 2024. Accessed Oct. 9, 2024.
For more information:
Ashraf Badros, MBCHB, can be reached at abadros@umm.edu.
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