Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL
Summary
The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.
Timeline
- Start
- 2012-11
- Primary completion
- 2017-03
- Completion
- 2021-02-17
Outcome
Met primary endpoint
paper Mogamulizumab therapy resulted in superior investigator-assessed progression-free survival compared with vorinostat therapy (median 7·7 months PMID 30100375 ↗
paper hazard ratio 0·53, 95% CI 0·41-0·69; stratified log-rank p<0·0001). PMID 30100375 ↗
release “mogamulizumab (KW-0761) in patients with cutaneous T-cell lymphoma (CTCL) met its primary endpoint of progression free survival.” kyowakirin.com ↗
release “Mogamulizumab, Demonstrates Significant Improvement in PFS Compared to Vorinostat in Patients with Previously Treated Cutaneous T-Cell Lymphoma (CTCL): Results from the Phase III MAVORIC Study” kyowakirin.com ↗
Publications
- Ortiz Romero PL, Kim YH, Molloy K, Quaglino P, Scarisbrick J, Thornton S, Sandilands K, Dent JE, Nixon A, Williams A, Shinohara MM. Health-related quality of life in cutaneous T-cell lymphoma: A post hoc analysis of a phase 3 trial in mycosis fungoides and Sezary syndrome. J Eur Acad Dermatol Venereol. 2025 Apr;39(4):833-845. doi: 10.1111/jdv.20357. Epub 2024 Sep 24.
- Kim YH, Bagot M, Pinter-Brown L, Rook AH, Porcu P, Horwitz SM, Whittaker S, Tokura Y, Vermeer M, Zinzani PL, Sokol L, Morris S, Kim EJ, Ortiz-Romero PL, Eradat H, Scarisbrick J, Tsianakas A, Elmets C, Dalle S, Fisher DC, Halwani A, Poligone B, Greer J, Fierro MT, Khot A, Moskowitz AJ, Musiek A, Shustov A, Pro B, Geskin LJ, Dwyer K, Moriya J, Leoni M, Humphrey JS, Hudgens S, Grebennik DO, Tobinai K, Duvic M; MAVORIC Investigators. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018 Sep;19(9):1192-1204. doi: 10.1016/S1470-2045(18)30379-6. Epub 2018 Aug 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mogamulizumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Comparator | Vorinostat | Small molecule | 400 mg | Oral |