Lena Specht, MD, DMSc, Professor of Clinical Oncology, and Chief Oncologist at Rigshopitalet, University of Copenhagen, Denmark, discusses her Danish study supporting the use of mogamulizumab in Danish patients with CTCL.
Mogamulizumab was approved in 2018 in Europe based on the results of the phase 3 MAVORIC trial, which was a randomized study comparing progression-free survival outcomes against vorinostat, an FDA-approved treatment, in patients with CTCL.
Vorinostat was never approved in Europe because it was associated with data issues and was not considered a valid study comparator by Danish authorities. As a result, mogamulizumab is currently not recommended for use in Denmark and therefore does not have reimbursement. The findings from this study hope to support ongoing efforts in obtaining a positive recommendation in Denmark, which would support access to treatment for appropriate patients.
Dr. Specht’s group of researchers attempted to compare data from the mogamulizumab arm of the MAVORIC study to the Danish standard of care by utilizing data from a real-world registry of Danish patients with CTCL from 1996 to 2024. They selected comparator patients from the registry according to MAVORIC inclusion criteria (including patients with either mycosis fungoides or Sézary syndrome who failed at least one line of systemic therapy). In addition, they evaluated data from the vorinostat arm in MAVORIC (i.e., those patients who did not switch over to mogamulizumab therapy).
The main outcome of interest was overall survival. They found overall survival to be longer (with a statistically significant difference) for those receiving mogamulizumab compared with the Danish patients with CTCL in the real-world registry. Although making treatment comparisons using nonrandomized patient data is problematic, Dr. Specht and her researchers were reassured that there was not any significant difference in the outcomes of those in the vorinostat treatment arm of MAVORIC and in the Danish registry population receiving standard of care.
Normally, Sézary syndrome is very difficult to treat, but mogamulizumab seems to work better in these patients than in those with mycosis fungoides, which is generally considered a less-aggressive cancer. According to Dr. Specht, this is a strong argument for access to mogamulizumab in patients with Sézary syndrome.
To learn more about CTCL, visit https://checkrare.com/cutaneous-t-cell-lymphoma-2/