The European Commission (EC) has granted marketing authorization for mogamulizumab (Poteligeo), a humanized monoclonal antibody directed against CCR4.
This means mogamulizumab is approved for use in adults with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
This approval is valid in all countries of the European Union as well as Norway, Iceland, and Liechtenstein.
Kyowa Kirin plans to launch mogamulizumab in various European markets starting next year.
The EC’s decision to approve mogamulizumab was supported by the phase 3 MAVORIC trial. Results from this trial were published in The Lancet Oncology in August.
MAVORIC was a comparison of mogamulizumab and vorinostat in 372 adults with MF or SS who had received at least one prior systemic therapy.
Mogamulizumab provided a significant improvement in progression-free survival (PFS), the study’s primary endpoint.
According to investigators, the median PFS was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio=0.53, P<0.0001).
According to an independent review committee, the median PFS was 6.7 months and 3.8 months, respectively (hazard ratio=0.64, P<0.0007).
There was a significant improvement in overall response rate (ORR) with mogamulizumab.
According to independent review, the global ORR was 23% (43/186) in the mogamulizumab arm and 4% (7/186) in the vorinostat arm (risk ratio=19.4, P<0.0001).
According to investigators, the global ORR was 28% (52/186) and 5% (9/186), respectively (risk ratio=23.1, P<0.0001).
For patients with MF, the investigator-assessed ORR was 21% (22/105) with mogamulizumab and 7% (7/99) with vorinostat.
For SS patients, the investigator-assessed ORR was 37% (30/81) and 2% (2/87), respectively.
Grade 3 adverse events (AEs) in the mogamulizumab arm included drug eruptions (n=8), hypertension (n=8), pneumonia (n=6), fatigue (n=3), cellulitis (n=3), infusion-related reactions (n=3), sepsis (n=2), decreased appetite (n=2), AST increase (n=2), weight decrease (n=1), pyrexia (n=1), constipation (n=1), nausea (n=1), and diarrhea (n=1).
Grade 4 AEs with mogamulizumab were cellulitis (n=1) and pneumonia (n=1). Grade 5 AEs included pneumonia (n=1) and sepsis (n=1).