Safety profile for POTELIGEO1
Median treatment exposure was 5.6 months for patients treated with POTELIGEO and 2.8 months for patients treated with vorinostat
- POTELIGEO patients were treated twice as long with nearly half of patients staying on therapy for at least 6 months
Serious adverse reactions reported in >2% of patients randomized to POTELIGEO were1:
- Pneumonia (5%), sepsis (4%), pyrexia (4%), skin infection (3%)
Adverse reactions in ≥10% of patients with a ≥2% higher incidence within the POTELIGEO treatment arm1,2,a,b
Of the 136 patients who crossed over to POTELIGEO, 20% were due to adverse reactions.3
No specific laboratory test is required to prescribe POTELIGEO.
- aAdverse reactions include groupings of individual preferred terms.
- bIncludes adverse reactions reported up to 90 days after randomized treatment.
- cPer study protocol, no prophylactic premedication with corticosteroids was permitted; however, patients taking low-/intermediate-potency topical steroids or low-dose (≤20 mg) systemic steroids for at least 4 weeks could continue.
No new safety issues with exposure up to 5 years1,4
Laboratory abnormalities in ≥10% of patients with a ≥2% higher incidence within the POTELIGEO treatment arm1
- dIncludes lab abnormalities reported up to 90 days after treatment that were new or worsening in grade or with worsening from baseline unknown.
- eOut of 99 evaluated recipients of POTELIGEO and 36 evaluable recipients of vorinostat.
- No specific laboratory test is required to prescribe POTELIGEO
Discontinuation1,3
-
POTELIGEO was discontinued due to adverse reactions in 18% of patients1
- Most frequent was rash (drug eruption) (7%) -
Vorinostat was discontinued due to adverse reactions in 23% of patients3
- 20% of patients crossed over to POTELIGEO due to adverse reactions
Being able to distinguish between treatment-related rash and disease progression is an
important step in managing patients
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References:
- POTELIGEO [package insert]. 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
- 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.
- Bagot M, Dalle S, Sokol L, et al. Long-term disease control and safety with the anti-CCR4 antibody mogamulizumab: post-hoc analyses from the MAVORIC trial of patients with previously treated cutaneous T-cell lymphoma. Dermatol Ther. 2022;35(8):e15634.