ASH 2015: Updated Results of the Phase I/II GEN503 Study of Daratumumab in Multiple Myeloma
In a study update presented by Plesner et al at the 57th American Society of Hematology (ASH) Annual Meeting, daratumumab (Darzalex) was shown to be safe and effective in combination with lenalidomide (Revlimid) and dexamethasone in patients with relapsed/refractory multiple myeloma (Abstract 507).
Daratumumab, the first targeted antibody therapy for multiple myeloma, is an experimental agent that is part of a new class of drugs called anti-CD38 antibodies. These drugs first bind to the CD38 protein expressed on the surface of myeloma cells and then signal immune cells to kill the cell directly.
Study Details
In this phase I/II study of daratumumab in combination with standard multiple myeloma therapy, lenalidomide and dexamethasone, researchers sought to evaluate whether this treatment combination is safe and effective for patients with relapsed or treatment-resistant multiple myeloma.
Thirty-two patients received weekly doses of daratumumab in combination with standard therapy during the first two 28-day therapy cycles, and then biweekly infusions during the next four cycles followed by once monthly infusions. Patients received the treatment until their disease progressed or side effects became too severe to continue.
Study Results
As of October 2, 2015, 22 patients remained on treatment. Ten (3%) discontinued treatment due to disease progression, adverse events, or investigator decision. The overall response rate was 81%, and 63% had a very good partial response or better.
The median duration of response was not reached.
Results of the study suggest that daratumumab is a safe and effective treatment for patients with relapsed or treatment-resistant multiple myeloma.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
