On the 8th of August 2018, the FDA approved mogamulizumab-kpkc (Poteligeo®, Kyowa Kirin), a CC chemokine receptor type 4 (CCR4) directed monoclonal antibody, for use in adult patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL).

Study 0761-010

In a randomised, open-label, multicentre trial (Study 0761-010; NCT01728805), 372 relapsed or refractory cutaneous mycosis fungoides (MF [55%]) or Sézary syndrome (SS [45%]) patients were randomised to either mogamulizumab or vorinostat. The participants had received a median of 3 prior therapies.

The median PFS was 7.6 months (95% CI, 5.6-10.2) vs 3.1 months (95% CI, 2.8-4.0) for mogamulizumab-kpkc vs vorinostat arm (HR=0.53; 95% CI, 0.41-0.69; p<0.001), respectively. The confirmed overall response rate was 28% and 5%, respectively (p<0.001).

Safety

Common, all-grade, adverse reactions in ≥20% of patients included rash, infusion-related reactions, fatigue, diarrhoea, musculoskeletal pain, and upper respiratory tract infection. Serious adverse reactions occurred in 36% of patients, most often (16% of patients) from infection. Prescribing physicians should be alert for dermatologic toxicities, infusion reactions, infections, autoimmune complications, and complications of allogeneic haematopoietic stem cell transplantation, including severe and refractory graft-versus-host disease.

Prescribing information for Poteligeo.

More information.