Daratumumab meets endpoint as first-line multiple myeloma therapy
Danish Genmab A/S’ anti-CD38 antibody daratumumab has met the endpoint of progression-free survival in an interim analysis of Genmab’s pivotal Phase III study aimed at receiving FDA approval as first-line therapy in multiple myeloma.
According to Genmab, the ALCYONE study (NCT02195479) of daratumumab in combination with bortezomib, melphalan and prednisone (VMP) in front line multiple myeloma met the primary endpoint at a pre-planned interim analysis vs VPM. The study improved progression free survival (PFS) (Hazard Ratio = 0.50 (95% CI 0.38-0.65), p < 0.0001). Treatment with daratumumab reduced the risk of disease progression or death by 50%, as compared to those who did not receive daratumumab. The median PFS for patients treated with daratumumab in combination with VMP has not been reached, compared to an estimated median PFS of 18.1 months for patients who received VMP alone.
Overall, the safety profile of daratumumab in combination with VMP was consistent with the known safety profile of the VMP regimen and the known safety profile of daratumumab.
Based on the results at the pre-planned interim analysis conducted by an Independent Data Monitoring Committee (IDMC), it was recommended that the data be unblinded. All patients will continue to be monitored for safety and overall survival. Further analysis of the safety and efficacy data is underway and Janssen Biotech, Inc., which licensed daratumumab from Genmab in 2012, will discuss with health authorities the potential for a regulatory submission for newly diagnosed multiple myeloma patients who are not considered candidates for autologous stem cell transplantation.