Table 1.
Trial | Design | Population | Response Rates | Survival | Notes |
---|---|---|---|---|---|
mogamulizumab 75 | open-label randomized trial of mogamulizumab vs. inv.’s choice | R/R aggressive ATL with ≥ 1 prior systemic therapy |
mogamulizumab: ORR: 11% best response: 34% inv.’s choice: ORR: 0% best response: 0% |
median PFS: 0.93 (moga) vs. 0.88 m median OS*: 4.9 (moga) vs. 6.9 m |
mogamulizumab is not approved in US for use in R/R ATL but is NCCN listed |
CHOP + mogamulizumab 37 | single-arm efficacy evaluation of CHOP x 3 followed by mogamulizumab x 8 | untreated, transplant-ineligible Japanese patients with ATL | ORR: 87.5% |
12-month PFS: 26.6% 12-month OS: 52.6% |
mogamulizumab + more intensive chemotherapy is approved in Japan (not US) based on prior studies38 |
valemetostat 97 | open-label, single-arm, phase II | R/R aggressive ATL after prior moga or ≥ 1 systemic therapy if moga contraindicated |
ORR: 48.0% CR: 20.0% |
median PFS: 7.4 m median OS: 16.4 m |
valemetostat is approved in Japan for R/R ATL |
Crossover allowed.
CHOP, cyclophosphamide, doxorubicin, vincristine, prednisone; inv.’s choice, investigator’s choice; moga, mogamulizumab; NCCN, National Comprehensive Cancer Network; ORR, objective response rate; OS, overall survival; PFS, progression-free survival, US, United States.