Kyowa Kirin has reported safety results from the MAVORIC clinical trial of Poteligeo (mogamulizumab-kpkc) in patients with cutaneous T-cell lymphoma (CTCL).
Formulated for intravenous administration, Poteligeo is a humanised monoclonal antibody (mAb) that targets CC chemokine receptor 4 (CCR4) expressed on the leukaemic cells of some hematologic malignancies, such as CTCL.
The drug is approved in the US to treat adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) following at least one previous systemic therapy.
MAVORIC is a randomised study that compared the drug to vorinostat in CTCL subtypes. The primary endpoint of the trial was progression-free survival (PFS), while secondary endpoints included overall response rate (ORR), duration of response and safety.
The final safety analysis involved a median duration of 34.5 months follow-up, along with median treatment exposure of 170 days for mogamulizumab and 84 days for vorinostat.
Results did not show any new safety signals. The adverse events (AEs) type and frequency in both treatment groups were consistent with those observed in the primary analysis.
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The rate of treatment-emergent adverse events (TEAEs), which were reported to be constipation, peripheral oedema, headache and anaemia, was similar in the treatment groups.
Kyowa Kirin chief development officer Jeffrey Humphrey said: “We are pleased that this final safety analysis from the MAVORIC study in patients with previously treated MF and SS demonstrates the additional two years of mogamulizumab safety follow up and treatment exposure did not identify any unexpected safety findings.”
Primary data from the MAVORIC trial supported the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals of mogamulizumab to treat the most common CTCL subtypes, MF and SS.