H. Miles Prince, MD, MBBS, Professor at the University of Melbourne, Australia, and Director, Peter MacCallum Cancer Center, and Director of Molecular Oncology and Cancer Immunology, Epworth HealthCare, describes the objectives and results of a new investigation which studied the previous results from the MAVORIC trial in patients with cutaneous T-cell lymphoma with those of patients in an Australian cancer registry.
The mogamulizumab versus vorinostat therapy in previously treated cutaneous T-cell lymphoma (MAVORIC) trial sought to compare the efficacy of the monoclonal antibody mogamulizumab against the standard of care (vorinostat) in patients with mycosis fungoides or Sézary syndrome, which together comprise cutaneous T-cell lymphoma (CTCL).
Patients were eligible if they had failed at least one previous systemic therapy. They were randomized to one of two treatment arms: mogamulizumab or vorinostat. Researchers found that the study was superior in terms of the main clinical endpoint of the study—progression-free survival (PFS) (7.7 mo vs. 3.1 mo; hazard ratio = 0.53; P < .0001).
The study also included a crossover arm for patients who could not tolerate vorinostat or whose disease progressed. Total overall survival (OS) for the intent-to-treat population taking mogamulizumab was just less than 5 years, but the difference from the comparator group was not statistically significant, possibly due to the crossover arm, according to Dr. Prince. Yet, the regulatory authorities of several countries, including those in northern Europe and Australia, require OS as primary clinical endpoint when seeking market authorization.
To determine whether mogamulizumab exhibited a true OS benefit, his team of researchers evaluated an Australian cancer registry, seeking patients who took vorinostat and who fulfilled MAVORIC study inclusion criteria. Matched to those in the study arm of MAVORIC, they were able to confirm a distinct improvement in OS in those taking mogamulizumab.
The results of this research help fulfill the OS data requirements for regulatory approval of mogamulizumab, but it also raises questions as to whether it should be used first line, especially in patients with aggressive forms of CTCL. Furthermore, it might be interesting to consider mogamulizumab as a foundation for drug combinations in managing this difficult-to-treat cancer.
To learn more about CTCL, visit https://checkrare.com/cutaneous-t-cell-lymphoma-2/
