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 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. As a result, the Danish regulatory authorities approved mogamulizumab for use only after a trial of one prior line of systemic chemotherapy. In comparison, the US FDA approved mogamulizumab for use as first-line treatment of CTCL.
Dr. Specht’s group of researchers attempted to compare the randomized phase 3 trial comparing mogamulizumab and the Danish standard of care by utilizing the MAVORIC study data along with 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 myocosis 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 first line 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 first-line access to mogamulizumab in patients with Sézary syndrome.
To learn more about CTCL, visit https://checkrare.com/cutaneous-t-cell-lymphoma-2/
