Daratumumab Triplet Approved for Relapsed or Refractory Myeloma
On June 19, 2017, the U.S. Food and Drug Administration (FDA) has approved daratumumab in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have been treated with at least two prior therapies, including lenalidomide and a proteasome inhibitor.
The approval was based on data from the phase I EQUULEUS (MMY1001) trial of patients with relapsed or refractory myeloma, in which 103 patients received the daratumumab triplet (16 mg/kg of daratumumab in combination with pomalidomide and dexamethasone). The overall response rate was 59%, with a very good partial response achieved in 28% of patients, a complete response achieved in 6% of patients, and a stringent complete response achieved in 8% of patients. The median time to response was 1 month, and the median duration of response was 13.6 months.
Serious adverse reactions were observed in 49% of patients. However, the only grade 3/4 serious adverse reaction reported in more than 5% of patients was pneumonia (7%).
The FDA previously approved daratumumab in combination with lenalidomide and dexamethasone, or in combination with bortezomib and dexamethasone, for patients with relapsed multiple myeloma following at least one prior therapy.