Abstract
In the large international phase III MAVORIC trial, patients with previously treated cutaneous T-cell lymphoma who received the anti-CCR4 monoclonal antibody mogamulizumab experienced significantly longer progression-free survival and higher response rates, as well as better quality of life, than those who received vorinostat, a standard therapy.
In a large international trial, patients with previously treated cutaneous T-cell lymphoma (CTCL) who received the anti-CCR4 monoclonal antibody mogamulizumab (Kyowa Hakko Kirin) experienced significantly longer progression-free survival (PFS) and higher response rates, as well as better quality of life, than those who received standard therapy. Findings from the trial were presented at the 2017 American Society of Hematology Annual Meeting, held last month in Atlanta, GA.
CTCL is a rare cancer that affects T lymphocytes. The disease is characterized by itching and visible skin lesions that develop as the abnormal cells accumulate. “It's an extremely debilitating type of lymphoma,” explained Laurie Sehn, MD, of the British Columbia Cancer Agency and the University of British Columbia in Vancouver, Canada. “Most of the chemotherapies that we use for other lymphomas don't seem to work.… Doctors and patients are looking forward to more effective therapies.”
One such possibility is mogamulizumab. After it demonstrated a tolerable safety profile and promising efficacy in a phase I/II study, researchers launched the phase III MAVORIC study, which enrolled 372 patients with CTCL who had already tried at least one systemic therapy. Patients were randomly assigned to receive either mogamulizumab, given intravenously once a week, or the histone deacetylase inhibitor vorinostat (Zolinza; Merck), a pill taken once a day.
The median PFS was 7.7 months for patients treated with mogamulizumab and 3.1 months for those treated with vorinostat, reported Youn Kim, MD, director of the Multidisciplinary Cutaneous Lymphoma Program at the Stanford University School of Medicine in California. The overall response rate was 28%, with four complete responses, in the mogamulizumab arm, compared with 4.8% and no complete responses in the vorinostat arm. The difference in overall response rates between mogamulizumab and vorinostat was even greater in patients with Sézary syndrome, a common subtype of CTCL: 37% and 2.3%, respectively.
Researchers measured quality of life with the Skindex-29 questionnaire. Patients who received mogamulizumab reported greater “meaningful symptom improvement” compared with those who received vorinostat, Kim said.
The side effects of the drugs differed. Rashes and infusion-related reactions were more common among patients who received mogamulizumab, whereas diarrhea, nausea, altered taste, decreased appetite, increased blood creatinine levels, and decreased platelet counts occurred more frequently in those who took vorinostat. These adverse effects were “very manageable,” Kim said, adding that the safety profile was consistent with previous reports.
The FDA granted Priority Review to mogamulizumab, which is already approved in Japan, in November, and a decision is expected by early June. “We hope that this drug will be approved … to add to the limited options that we have” for patients with CTCL, Kim said. –Suzanne Rose
