Phase III ALCYONE study (MMY3007) of daratumumab in combination with bortezomib, melphalan and prednisone (VMP) versus VMP alone as front line treatment for newly diagnosed patients in front line multiple myeloma.-Janssen Biotech

Genmab A/S announced topline results from the Phase III ALCYONE study (MMY3007) of daratumumab in combination with bortezomib, melphalan and prednisone (VMP) versus VMP alone as front line treatment for newly diagnosed patients in front line multiple myeloma , who are not considered candidates for autologous stem cell transplantation (ASCT). The study met the primary endpoint of improving progression free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 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 is 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 this indication. The data are expected to be submitted for presentation at an upcoming medical conference and for publication in a peer-reviewed journal.