The Lancet has published data from Kyowa Hakko Kirin Co’s successful Phase III trial of immunotherapy Poteligeo underpinning its recent approval in the US to treat in patients with cutaneous T-cell lymphoma (CTCL).
MAVORIC was the open-label randomised multi-center Phase III trial that evaluated Poteligeo (mogamulizumab) versus vorinostat for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) - the most common subtypes of CTCL - after at least one prior systemic therapy.
According to the data, Poteligeo showed significantly superior PFS at a median of 7.7 months versus to 3.1 months with vorinostat, thus meeting the primary endpoint.
Also, the objective response rate was 28 percent vs 4.8 percent, median duration of response was 14.1 months vs 9.1 months and, on the safety side, findings were consistent with previous studies of Kyowa’s drug.
Grade 3–4 adverse events were reported in 41 percent of 184 patients in the Poteligeo group and 41 percent of 186 patients in the vorinostat group, while the most common serious adverse events were pyrexia in eight (4 percent) patients and cellulitis in five (3 percent) patients in the Poteligeo group and cellulitis in six (3 percent) patients, pulmonary embolism in six (3 percent) patients, and sepsis in five (3 percent) patients in the vorinostat group.
"Mycosis fungoides and Sézary syndrome can be debilitating for patients and complex to treat and manage for healthcare professionals," said Jeffrey Humphrey, chief medical officer and President of Kyowa Kirin Pharmaceutical Development.
"We are encouraged that these findings underscore the viability of mogamulizumab as a new treatment option for patients living with MF or SS."
Poteligeo is a humanised, afucosylated monoclonal antibody targeting CC chemokine receptor 4 (CCR4), and the first biologic agent targeting CCR4 to be available for patients in the US.