Emerging treatments
Lacutamab
Lacutamab, a first-in-class anti-KIR3DL2 cytotoxicity-inducing antibody, has been granted breakthrough therapy designation (intended to accelerate development and regulatory review) by the Food and Drug Administration (FDA) for the treatment of adults with relapsed or refractory Sezary syndrome after at least two prior systemic therapies, including mogamulizumab. This was based on the results of a phase 1 trial, and the initial reporting of the ongoing phase 2 open-label, multi-cohort TELLOMAK trial, which demonstrate benefit in this population.[113]
KT-333
KT-333, a first-in-class degrader of the transcriptional regulator STAT3, has been granted orphan drug designation for the treatment of CTCL by the FDA. A phase Ib trial is ongoing.[114]
Topical therapies
A number of topical treatments have been reported as effective treatment for mycosis fungoides in case reports or small series (off-label use) including fluorouracil and tacrolimus. Randomised trials have not been done. However, these therapies may be considered for localised or refractory disease when skin-directed therapy is still considered appropriate.
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