FIRST LINE DARATUMAB FOR MM

On August 24, positive topline results were announced from the phase III ALCYONE study of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) vs VMP alone as front-line treatment for newly diagnosed patients who are not considered candidates for autologous stem cell transplantation. The study met the primary endpoint of improving progression-free survival at a preplanned interim analysis (hazard ratio = 0.50, 95% confidence interval = 0.38–0.65; P < .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 progression-free survival for patients treated with daratumumab in combination with VMP has not been reached, compared to an estimated median progression-free survival 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 preplanned interim analysis conducted by an independent data monitoring committee, 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. 

“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. We are very pleased with the outcome of the preplanned 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,” said Jan van de Winkel, PhD, Chief Executive Officer of Genmab.

About the Study

The phase III ALCYONE study is a randomized, open-label, multicenter study that includes 706 newly diagnosed patients with multiple myeloma who are ineligible for autologous stem cell transplantation. Patients were randomized to receive 9 cycles of either daratumumab combined with VMP and prednisone or VMP alone. In the daratumumab treatment arm, patients received 16 mg/kg of daratumumab once weekly for 6 weeks (cycle 1), followed by once every 3 weeks (cycles 2–9). Following the 9 cycles, patients in the daratumumab treatment arm continued to receive 16 mg/kg of daratumumab once every 4 weeks until disease progression. The primary endpoint of the study is progression-free survival.