MAVORIC Results Support FDA Approval of Mogamulizumab in Cutaneous C-Cell Lymphoma
Posted: Thursday, October 18, 2018
The results of the open-label, phase III MAVORIC trial published in The Lancet Oncology highlight the superior progression-free survival rates achieved with mogamulizumab compared with vorinostat in patients with previously treated cutaneous T-cell lymphoma—specifically, relapsed or refractory mycosis fungoides or Sézary syndrome. These findings with the anti–C-C chemokine receptor 4 (CCR4) monoclonal antibody mogamulizumab support its recent approval by the U.S. Food and Drug Administration in this setting.
“We anticipate that in the future, additional treatment options will become available for cutaneous T-cell lymphoma, and studies that compare mogamulizumab with newer therapies, either as monotherapy or in combination, will be warranted,” concluded Youn H. Kim, MD, of the Stanford Cancer Institute at Stanford University School of Medicine, California, and colleagues.
The median progression-free survival, MAVORIC’s primary endpoint, was 7.7 months with mogamulizumab versus 3.1 months with vorinostat (P < .0001). A total of 372 adult patients from 61 sites worldwide were originally randomized between December 2012 and January 2016. At the data cutoff, 27 patients receiving mogamulizumab and 10 receiving vorinostat remained on study treatment, as did 31 patients in the vorinostat group who had crossed over to mogamulizumab.
“In general, a benefit for mogamulizumab in terms of the proportion of patients achieving an overall response was seen across disease stages,” noted Dr. Kim and his team. As for toxicity, grade 3 to 4 [adverse events] of any cause were reported in 41% of both groups.