Targeted antibody demonstrates significant improvement in PFS in patients with previously treated CTCL

A randomised Phase III trial, MAVORIC, reveals that patients with previously treated cutaneous T-cell lymphoma (CTCL) who received mogamulizumab had significantly improved progression-free survival, response rate and QoL than patients who were administered vorinostat. Furthermore, the adverse events recorded for mogamulizumab, an investigational targeted drug, were mild to moderate in severity.

Of the 372 patients included in the trial, the median progression-free survival was 7.7 months for patients treated with mogamulizumab, versus 3.1 months for those treated with vorinostat.

 

 

We found that mogamulizumab has convincing clinical activity, not just in skin, but also in clearing malignant T-cells in the blood and lymph nodes. Progression-free survival and overall global response outcomes are clearly superior, the side effects are tolerable, and we see measurable improvements in quality of life with mogamulizumab compared with vorinostat. Taken together, these findings represent a durable and clinically meaningful benefit for patients with CTCL.

Lead study author Youn H. Kim, MD, professor of dermatology and director of the Multidisciplinary Cutaneous Lymphoma Program at the Stanford University School of Medicine.

Further detail from the official press release of ASH 2017:

CTCL is a rare cancer of the white blood cells, specifically T lymphocytes, that primarily occurs in the skin. It is caused when T cells (cells in the immune system that help the body fight infection) begin to grow uncontrollably and build up in the skin. CTCL can also involve the blood, lymph nodes, and internal organs.

Mogamulizumab targets a protein (CCR4) that is frequently found on the surface of cancer cells in patients with CTCL. As a CCR4 antibody, the drug exploits the patient’s immune cells to attack the cancer, Dr. Kim explained. Vorinostat, one of several drugs approved by the FDA to treat CTCL, works by blocking the action of an enzyme that helps cancerous T-cells survive and multiply.

Adverse effects such as diarrhea, nausea, altered taste, decreased appetite, increased blood creatinine levels, and decreased platelet counts occurred more than twice as frequently in patients treated with vorinostat than in those treated with mogamulizumab, said Kim. By contrast, the adverse effects seen most frequently in patients treated with mogamulizumab were drug rash and infusion-related reactions, such as chills and flushing. Mogamulizumab was administered as a once-weekly intravenous infusion for the first 28-day cycle and every two weeks during subsequent cycles. Vorinostat was taken as a once-daily pill.