What are the roles of daratumumab (Darzalex), ixazomib (Ninlaro), and elotuzumab (Empliciti) in the treatment of multiple myeloma (MM)?

Updated: May 11, 2021
  • Author: Dhaval Shah, MD; Chief Editor: Emmanuel C Besa, MD  more...
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Answer

Daratumumab (Darzalex) gained approval from the FDA in 2015 for patients with MM who had received at least three prior treatments, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or whose disease is refractory to both a PI and an IMiD. The approval was based on the phase II MMY2002 (SIRIUS) study that showed treatment with single-agent daratumumab resulted in an ORR of 29.2% in patients who received a median of five prior lines of therapy, including a PI and an IMiD. [91]

Stringent complete response (sCR) was reported in 2.8%, very good partial response (VGPR) was reported in 9.4%, and partial response (PR) was reported in 17% of patients. For responders, the median duration of response was 7.4 months. At baseline, 97% of patients were refractory to their last line of therapy, 95% were refractory to both a PI and an IMiD, and 77% were refractory to alkylating agents. [91] These data are supported by similar results from a phase I/II trial. [92]


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