Photo courtesy of Janssen
Daratumumab (Darzalex)
Interim results of a phase 3 study suggest adding daratumumab to a 3-drug regimen can improve progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (MM).
In the phase 3 ALCYONE study, researchers are comparing daratumumab in combination with bortezomib, melphalan, and prednisone (VMP) to VMP alone in patients with newly diagnosed MM who are not considered candidates for autologous stem cell transplant.
Genmab A/S recently announced interim results from this trial and said additional data are expected to be submitted for presentation at an upcoming medical conference and for publication in a peer-reviewed journal.
The ALCYONE trial enrolled 706 patients who were randomized to receive 9 cycles of daratumumab plus VMP or VMP alone.
In the daratumumab arm, patients received 16 mg/kg of daratumumab once weekly for 6 weeks (cycle 1; 1 cycle = 42 days), followed by once every 3 weeks (cycles 2-9). After that, patients continued to receive 16 mg/kg of daratumumab once every 4 weeks until disease progression.
At the pre-planned interim analysis, the study’s primary endpoint was met. Treatment with daratumumab reduced the risk of disease progression or death by 50% when compared to VMP alone (hazard ratio=0.50; 95% CI 0.38-0.65; P<0.0001).
The median PFS has not been reached in the daratumumab arm but was an estimated 18.1 months for patients who received VMP alone.
Genmab said that, 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 these results, an independent data monitoring committee recommended the data be unblinded. All patients will continue to be monitored for safety and overall survival.
Janssen Biotech, Inc., which licensed daratumumab from Genmab in 2012, said it will discuss with health authorities the potential for a regulatory submission for daratumumab in combination with VMP as a treatment for newly diagnosed MM.
Daratumumab is already approved in the US (as DARZALEX®) for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, to treat MM patients who have received at least 1 prior therapy.
Daratumumab is also approved for use in combination with pomalidomide and dexamethasone to treat MM patients who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor (PI).
And daratumumab is approved as monotherapy for MM patients who have received at least 3 prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.
