Michael E. Williams, MD, ScM reviewing Lonial S et al. Lancet 2016 Jan 6. Rajkumar SV. Lancet 2016 Jan 6.

The monoclonal antibody daratumumab provided an antitumor response in 29% of patients.

Whereas monoclonal antibody therapy has been a mainstay of lymphoma regimens for many years, the development of these agents has lagged for multiple myeloma.

To test the efficacy and safety of the anti-CD38 monoclonal antibody daratumumab in multiple myeloma, investigators conducted an industry-sponsored, multinational, randomized, phase II trial involving 106 patients with relapsed disease that was refractory to both proteasome inhibitors and immunomodulatory agents. Most patients (80%) had received prior high-dose therapy and autologous stem cell transplantation, and 97% were resistant to their most recent treatment. Patients received a dose of 16 mg/kg weekly for 8 weeks, then biweekly for16 weeks, and then once every 4 weeks until disease progression or treatment intolerance.

Results were as follows:

The objective response rate (the primary endpoint) was 29%.

12% of patients achieved a very good partial remission or a stringent complete remission.

The median time to initial response was 4 weeks.

The median duration of response was 7.4 months.

Treatment toxicity occurred in a minority of patients and included infusion reactions, fatigue, and cytopenias.

Citation(s):

Lonial S et al. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): An open-label, randomised, phase 2 trial. Lancet 2016 Jan 6; [e-pub].

Rajkumar SV.Daratumumab in multiple myeloma. Lancet 2016 Jan 6; [e-pub]. 

JWatch