medwireNews: MAVORIC trial results support the use of the C-C chemokine receptor 4 (CCR4)-targeted antibody mogamulizumab over the standard of care vorinostat in previously treated patients with mycosis fungoides or Sézary syndrome.
Among 372 patients with these cutaneous T-cell lymphomas, the primary endpoint of investigator-assessed progression-free survival (PFS) was significantly longer for the participants who were randomly allocated to receive mogamulizumab than for those treated with the histone deacetylase inhibitor, at a median of 7.7 and 3.1 months, respectively.
This equated to a significant 47% reduction in the risk for progression or death in favor of the first-in-class anti-CCR4 agent, report lead author Youn Kim, from Stanford University in California, USA, and colleagues.
The phase III trial included patients with stage IB–IVB mycosis fungoides (56%) or Sézary syndrome (44%) who had failed at least one prior systemic treatment (median=3). Participants received either intravenous mogamulizumab 1 mg/kg – weekly for the first 28-day cycle, after which it was given every 2 weeks – or oral vorinostat 400 mg/day.
Mogamulizumab-treated patients were also significantly more likely to achieve an overall response than their counterparts who received vorinostat, with rates of 28% versus 5%.
And patient-reported quality of life outcomes also improved to a greater degree at the 6-month timepoint in the mogamulizumab than vorinostat group.
An exploratory analysis of overall survival showed no significant difference between the mogamulizumab and vorinostat treatment arms, with the median unreached and 43.9 months, respectively, but Kim et al point out that the analysis was “confounded by the one-way crossover design,” allowing the use of mogamulizumab if vorinostat was discontinued for any reason.
They also note that the safety profile of mogamulizumab was “manageable and consistent with previous reports.”
The incidence of any-cause adverse events (AEs) of grade 3 or 4 was identical in both arms, at 41%, whereas serious AEs occurred in 38% of the mogamulizumab-treated patients and 25% of those given vorinostat.
Nineteen percent of patients in the mogamulizumab group discontinued treatment due to AEs, as did 23% of those in the vorinostat group, most commonly due to drug rash (7%) and fatigue (4%), respectively.
Two deaths in the mogamulizumab arm and three in the vorinostat arm were attributed to treatment-related AEs, according to the article published in The Lancet Oncology.
The study authors believe that mogamulizumab “could provide a new, effective treatment for patients with mycosis fungoides and, importantly, for Sézary syndrome, a subtype that represents a major therapeutic challenge in cutaneous T-cell lymphoma.”
And indeed, mogamulizumab was recently approved by the US FDA for the treatment of these cutaneous T-cell lymphoma subtypes.
The author of an accompanying commentary describes the results as “good news,” but notes that “most responses to mogamulizumab were partial rather than complete and disease relapse had occurred in many patients by 14 months.”
Robert Gniadecki (University of Alberta, Edmonton, Canada) continues: “Therefore, the responses seem to be relatively short-lived in many patients, suggesting that mogamulizumab might not be the long-awaited cure for cutaneous T-cell lymphoma.”
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