POTELIGEO more than doubled median PFS vs vorinostat (P<0.001)1
Primary endpoint: PFS*
*Investigator-assessed outcome.
In a post hoc analysis, POTELIGEO demonstrated greater PFS across all blood classifications vs vorinostat2
Primary endpoint: PFSa
BLOOD CLASSIFICATION
-
-
<15%
CD4+CD26- or CD4+CD7- cells by flow cytometry
-
-
≥15%
CD4+CD26- or CD4+CD7- cells by flow cytometry
-
-
≥1000/μL Sézary cells with positive clone
or 1 of the following:- CD4:CD8 ratio ≥10,
- 40% CD4+CD7- cells, or
- ≥30% CD4+CD26- cells
aPFS by blood classification was measured based on a post hoc analysis; a finding from the post hoc analysis cannot be used to demonstrate differences between treatments and may not be applicable to all patients initiating POTELIGEO.
POTELIGEO was evaluated in the largest randomized, open-label, phase 3 trial of a systemic therapy for patients with Mycosis Fungoides and Sézary Syndrome1,3,4
372 patients with Mycosis Fungoides (MF) and Sézary Syndrome (SS) were evaluated across Stage IB-IV for progression-free survival (PFS) as well as overall response rate (ORR) and duration of response (DoR) in multiple disease compartments (skin, blood, lymph nodes, viscera).
MAVORIC
Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL
The MAVORIC trial included a broad range of patients1,3
BLOOD CLASSIFICATION2,6
-
-
<15%
CD4+CD26- or CD4+CD7- cells by flow cytometry
-
-
≥15%
CD4+CD26- or CD4+CD7- cells by flow cytometry
-
-
≥1000/μL Sézary cells with
positive clone
or 1 of the following:- CD4:CD8 ratio ≥10,
- 40% CD4+CD7- cells, or
- ≥30% CD4+CD26- cells
| Patient characteristics1,5 | ||||
|---|---|---|---|---|
| Age (years) | ||||
| Age (years) | Median, 64 | Min, 25 | Max, 101 | |
| Sex | ||||
| Sex | Males, 58% | Females, 42% | ||
| Race | ||||
| Race | White, 70% | African American, 13% |
Asian, 7% | Other, 10% (Not reported) |
| Prior systemic therapies | ||||
| Prior systemic therapies | Median, 3 | Min, 0 | Max, 18 | |
Key exclusion criteria6
- Large cell transformation at study entry
- Active autoimmune diseases
- CNS metastasis
- Active infection requiring therapy
- Medical conditions requiring systemic corticosteroids or other immunosuppressive medication
CNS=central nervous system; CTCL=cutaneous T-cell lymphoma; PO=by mouth; R/R=relapsed or refractory
Overall response rate (ORR) and duration of response (DoR) were secondary endpoints in the MAVORIC trial1,6
See efficacy data- POTELIGEO [package insert]. Kyowa Kirin Inc., Princeton, NJ USA.
- Cowan R, Scarisbrick JJ, Zinzani PL, et al. Efficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial. J Eur Acad Dermatol Venereol. 2021;35(11):2225-2238.
- Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018;19(9):1192-1204.
- Kim Y, Bagot M, Zinzani PL, et al. Safety of mogamulizumab in mycosis fungoides and Sézary syndrome: final results from the phase 3 MAVORIC study. Blood. 2019;134(suppl):5300[abstract].
- Data on file. Kyowa Kirin Inc., Princeton, NJ USA.
- Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018;19(9):1192-1204. Supplementary appendix published online August 9, 2018. doi.org/10.1016/S1470-2045(18)30379-6