Newly-diagnosed multiple myeloma patients who are not eligible for a stem cell transplant reduce the risk of disease progression or death by half when Darzalex (daratumumab) is added to the combination of Velcade (bortezomib), melphalan, and prednisone, an interim analysis of a Phase 3 trial has revealed.
The study, called ALCYONE (NCT02195479), met its primary goal of improving progression-free survival, showing that the Darzalex combo is better at preventing disease progression than the Velcade, melphalan, and prednisole (VMP) combo. The trial is still recruiting participants.
“The interim results of the ALCYONE study yet again illustrate the potential of daratumumab in multiple myeloma in combination with existing treatment regimens; this time with VMP in the front line setting,” Jan van de Winkel, PhD, CEO of Genmab, said in a press release. “We are very pleased with the outcome of the pre-planned interim analysis in this study, which adds further to our hope that daratumumab could potentially become the critical driver redefining combination treatment in multiple myeloma.”
Darzalex intravenous infusion was originally approved by the U.S. Food and Drug Administration in 2015 for the treatment of multiple myeloma patients who have received at least three prior lines of therapy.
The randomized, open-label, multicenter Phase 3 study was designed to include 706 newly-diagnosed myeloma patients who could not be considered for stem cell transplant.
Participants were randomized to receive VMP, with or without Darzalex, for nine cycles. VMP includes the proteasome inhibitor Velcade, the chemotherapy melphalan, and the corticosteroid prednisone. Following the ninth cycle, patients on the Darzalex arm continued to receive Darzalex as a maintenance therapy once every 28 days until disease progression.
The study’s primary measure was progression-free survival. Secondary measures included time to disease progression, proportion of patients who responded to treatment, progression-free survival on second-line treatments, and overall survival.
An interim analysis conducted by an Independent Data Monitoring Committee (IDMC) revealed that patients on the control arm had a median progression-free survival of 18.1 months, but that it had not been reached in the Darzalex arm. This translated into a 50 percent reduction in the risk of disease progression or death in the Darzalex group.
All patients were monitored for safety, and results showed that the safety profile of the Darzalex combo was consistent with the known safety profile of Darzalex and VMP regimen.
Based on the findings, the IDMC recommended that the data be unblinded.
The trial’s final data collection date for primary outcome measure is scheduled for November 2017.
In 2012, Janssen Biotech and Genmab entered into a worldwide agreement which granted Janssen an exclusive license to develop, manufacture and commercialize Darzalex. Darzalex will be commercialized in the U.S. by Janssen Biotech.