Early Results from Multiple Myeloma Clinical Trial Prove Cancer Drug Combination Provides Longer Response and Potential Benefit in Disease-Free Survival

October 02, 2024

Patients with multiple myeloma, a type of cancer in their white blood cells, have a significantly longer disease-free period and likely long-term survival if they are treated with the monoclonal antibody drug daratumumab along with the standard therapy drug lenalidomide compared to the standard therapy alone. That is the finding of a new multi-center study led by University of Maryland School of Medicine investigators and presented earlier this week at the plenary session of the International Myeloma Society Meeting in Rio de Janeiro, Brazil and published online in the journal, Blood.

More than 35,000 Americans are diagnosed with multiple myeloma every year, according to the American Cancer Society, and nearly 13,000 people die from it. Treatments for multiple myeloma have significantly improved with the introduction of newer chemotherapy drugs, especially in those who are newly diagnosed. However, the disease remains incurable and maintenance therapy with lenalidomide has become the standard of care providing longer remissions and an improvement in overall survival.

The trial, called AURIGA, involved 200 patients with multiple myeloma who were randomly assigned to get daratumumab along with the standard therapy or to get the standard therapy alone for up to 36 monthly treatments. At 12 months, the minimal residual disease (MRD) negative conversion rate, which indicates deeper remission and a potential for longer survival, was 51 percent in the daratumumab group compared to nearly 19 percent in the control group. After 30 months of follow-up, the patients administered daratumumab plus standard therapy were 47 percent less likely to experience disease progression or death compared to the group on lenalidomide alone.

"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,” said Ashraf Badros, MB, ChB, principal investigator of the multi-site clinical trial and professor of medicine at UMSOM and Director of the Multiple Myeloma Service at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC), which is part of the University of Maryland Medical Center. “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.”

The daratumumab regimen was associated with slightly higher incidence of side effects including low blood cell counts (cytopenias), which occurred in 54 percent of daratumumab patients compared to 47 percent in the control group. Infections occurred in 19 percent of these patients compared to 13 percent who were given the standard therapy alone. That is likely because patients remained on the daratumumab regimen for longer periods. Overall, there were no new safety concerns for this trial.

“The results of this phase 3 study pave the way for the combination of daratumumab and lenalidomide to become a new standard maintenance therapy post-transplant in multiple myeloma patients,” said Taofeek Owonikoko, MD, PhD, the Marlene & Steward Greenebaum Distinguished Professor of Oncology at UMSOM and Executive Director of UMGCCC.

The study was funded by Janssen Biotech, Inc.