Japan-based Kyowa Hakko Kirin has reported positive results from the Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL (MAVORIC) study after meeting its primary endpoint.
MAVORIC is a Phase lll trial that examined mogamulizumab in comparison with vorinostat for the treatment of patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS), both of which are the most common subtypes of cutaneous T-cell lymphoma (CTCL).
The pivotal, open-label, randomised, multi-centre trial included 372 adult patients after at least one prior systemic therapy across 61 sites in 11 countries.
The trial’s primary endpoint was progression free survival (PFS), while its secondary endpoints comprised proportion of patients achieving an overall response (ORR), duration of response (DOR) and safety.
MAVORIC trial lead investigator Youn Kim said: “Progression-free survival captures the duration of disease control with treatment based on the composite response assessment of each disease compartment, skin, blood, lymph nodes, and viscera, and may more broadly reflect the overall impact of new therapies.
“Progression-free survival is more informative about the duration of overall clinical benefit for patients with a chronic course as in CTCL compared to using the overall response rate as a primary endpoint.”
During the MAVORIC trial, the patients were randomised in a 1:1 ratio to receive either 1.0mg/kg of mogamulizumab or 400mg of vorinostat for 28 days for each of the treatment cycle.
Patients on vorinostat who showed confirmed disease progression or experienced intolerable toxicity after two cycles could cross over to the treatment group with mogamulizumab.
Results from the MAVORIC trial revealed that mogamulizumab demonstrated significantly superior PFS at a median of 7.7 months compared to 3.1 months with vorinostat.
Furthermore, ORR, median DOR and response by disease were reportedly higher for patients assigned to mogamulizumab than for patients treated with vorinostat.
Among other data, the trial also reported that the safety profile of mogamulizumab was consistent with previous studies, with the most common adverse events of any grade including infusion-related reactions and drug rash.