Biotechnology company Genmab recently announced that an interim analysis of its Phase 3 clinical trial of daratumumab (Darzalex), in combination with lenalidomide and dexamethasone for multiple myeloma, met its primary endpoint for improving progression-free survival.
Daratumumab is an antibody binding CD38 — a factor expressed in high numbers on myeloma cells. Binding of the antibody triggers cell death and induces immune reactions by way of increased cytotoxic T-cells and lower numbers of regulatory cells.
An Independent Data Monitoring Committee (IDMC) performing the analysis recommended unblinding the data. Patients who were previously in the control group could now be offered daratumumab monotherapy if experiencing a disease progression. All patients will continue to be monitored for safety and survival.
Jenson Biotech, which acquired the exclusive worldwide license to develop, produce, and market daratumumab from Genmab, is still awaiting a final analysis of the safety and efficacy data but will initiate discussions with health authorities concerning a future regulatory submission to explore the antibody in other combination drug treatment for multiple myeloma.
Daratumumab was the first antibody to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma.
The recent study, called POLLUX, included 569 patients in which the cancer had either relapsed or was refractory to treatment. The interim analysis revealed a 63 percent reduction in risk of disease progression in patients receiving the three-drug combo, compared to patients on lenalidomide and dexamethasone alone.
Patients receiving lenalidomide and dexamethasone had a median progression-free survival time of 18.4 months. In contrast, the progression-free survival of the group with add-on daratumumab has not been reached yet.
The POLLUX trial results will be presented at the 21st Congress of the European Hematology Association (EHA) June 9 – 12 in Copenhagen. Results will also be submitted for publication.
Jan van de Winkel, chief executive officer of Genmab, said in a press release: “The POLLUX study is the second key Phase III study of daratumumab to meet the primary endpoint at a pre-planned interim analysis and demonstrates a favorable benefit-risk ratio. We have now seen that daratumumab can potentially be used to effectively treat relapsed or refractory multiple myeloma in combination with either lenalidomide or bortezomib, two standard of care multiple myeloma treatments.”