Novel Monoclonal Antibody in Relapsed or Refractory Multiple Myeloma
Posted: Wednesday, January 15, 2020
According to preliminary results presented at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando (Abstract 140), the novel anti-CD38 monoclonal antibody TAK-079 appeared to show activity in patients with relapsed or refractory multiple myeloma, with few adverse events. Amrita Y. Krishnan, MD, of the City of Hope Medical Center, California, and colleagues reported that pharmacodynamic analyses showed dose-dependent saturation of CD38 and depletion of bone marrow myeloma cells.
“[Subcutaneous] TAK-079 has a low treatment burden with the low volume (2 mL) subcutaneous injections performed in ≤ 1-minute, signifying the potential for home-based self-administration,” the authors commented. “The high potency of TAK-079 may result from selective binding to myeloma cells (ie, less binding to red blood cells and platelets).”
In this phase Ib study, a total of 31 patients with a median age of 65 and relapsed or refractory multiple myeloma were enrolled across 4 dose cohorts. Prior to the study, they were refractory or intolerant to at least one proteasome inhibitor and one immunomodulatory drug. The TAK-079 dose was given as a subcutaneously administered injection weekly for 8 doses, every other week for 8 doses, then monthly until disease progression or unacceptable toxicity. They received doses of either 45 mg, 135 mg, 300 mg, and 600 mg.
Early in the study, clinical activity occurred in patients treated with different doses. The objective response rate in the 14 patients receiving at least 4 cycles of therapy was 43%. In one case, the response deepened over time to a very good partial remission.
Disclosure: The study authors’ disclosure information can be found at ash.confex.com.