Abstract
Mogamulizumab-kpkc provides a novel mechanism of action for the treatment of mycosis fungoides and Sézary syndrome. The efficacy and safety of mogamulizumab-kpkc for the treatment of relapsed or refractory mycosis fungoides and Sézary syndrome were demonstrated in a multicenter, open-label, randomized phase III trial comparing mogamulizumab-kpkc with vorinostat. Patients treated with mogamulizumab-kpkc showed a statistically significant increased progression-free survival (PFS; 7.7 months) compared with vorinostat (3.1 months). Overall response rates were higher with mogamulizumab-kpkc compared with vorinostat (28% vs. 5%; p < .0001). The most common adverse events (> 20%) associated with mogamulizumab-kpkc include rash, infusion-related reaction, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection. The use of mogamulizumab-kpkc up to 50 days prior to allogeneic hematopoietic stem cell transplantation has been associated with an increased risk of severe acute graft-vs.-host disease, steroid-refractory graft-vs.-host disease, and mortality. Additional labeled warnings include dermatologic toxicity, infection, and autoimmune complications. The overall benefit to risk assessment of mogamulizumab-kpkc is acceptable, but its use is constrained by the high cost of treatment and the short-term benefit.
