Danish biotechnology firm Genmab has announced that Janssen Biotech will conduct a Phase III clinical trial of daratumumab as maintenance therapy for multiple myeloma, a form of blood cancer.
The randomised, open-label, multi-centre trial, called MMY3021, will assess daratumumab administered subcutaneously in conjunction with lenalidomide, compared to lenalidomide alone.
It will enrol up to 214 newly diagnosed patients who are minimal residual disease (MRD) positive following frontline autologous stem cell transplant (ASCT) and have no previous anti-CD38 exposure.
Daratumumab is a human IgG1k monoclonal antibody (mAb) designed to bind to the CD38 molecule and induce the patient’s immune system to attack the cancer.
Janssen Biotech is developing the drug under an exclusive worldwide licence from Genmab.
The US Food and Drug Administration (FDA) granted breakthrough therapy designations for the drug as a monotherapy, as well as a combination to treat multiple myeloma.
Genmab CEO Jan van de Winkel said: “We are hopeful that the study will provide evidence of daratumumab’s potential to provide a benefit to patients with multiple myeloma beyond current standard of care treatments in the maintenance phase of treatment.”
During the Phase III trial, subjects will be initially given 1,800mg subcutaneous daratumumab weekly, followed by two weeks cycles and every four weeks thereafter.
Participants will receive 10mg oral lenalidomide on days one to 28. The dose will be increased to 15mg daily if it is well-tolerated post three cycles. Both treatments will be continued until disease progression or for 36 cycles.
The primary endpoint of the study is MRD conversion rate, from positive to negative, at 12 months.
Set to begin in the first half of this year, the trial is expected to be completed in May 2023.