Table 1.

Select advances and upcoming approaches in systemic therapies in MF/SS

DrugMechanismApprovalaORRbCompartmental effect (ORR)2 Notable adverse reaction(s)
Brentuximab vedotin7  Anti-CD30 ADC R/R CD30+ MF after 1 prior systemic therapy 65.6% ≤IIA: 53%
IIB: 68%
IIA-IIIB: 75%
IVA: 100% (2/2)c
IVB: 57% 
Peripheral sensory and motor neuropathy 
Mogamulizumab8  Anti-CCR4 Ab R/R MF/SS after 1 prior systemic therapy MF: 21%
SS: 37% 
Skin: 42%
Node: 17%
Blood: 68%
Viscera: 0%d 
Infusion-related reaction, rash (see text for discussion) 
E777740  Recombinant IL2-diptheria toxin protein R/R MF/SS after 1 prior systemic therapy 36.2% — Infusion-related reaction, capillary leak syndrome, visual impairment 
Lacutamab14-16  Anti-KIR3DL2 Ab No SS: 37.5%e Skin: 46.4%
Node: 19.6%
Blood: 48.2%
Viscera: NR 
Peripheral edema 
Pembrolizumab17  Anti–PD-1 therapy No (NCCN) 38% IB: 0% (0/1)
IIB: 100% (2/2)
IIIA: 100% (2/2)
IIIB: 33% (1/3)
IVA: 25% (4/16) 
Rash/flare, immune-related toxicity 
Tislelizumab41
 
Anti–PD-1 therapy No 46% — Rash/flare, immune-related toxicity (observed in only 1 patient with SS in study, recovered within 4 days) 
DR-01 (NCT05475925) Anti-CD94 Ab targeting cytotoxic TCLs, including MF, PCAETCL, PCGDTCL No Ongoing study, with data to be reported 
DrugMechanismApprovalaORRbCompartmental effect (ORR)2 Notable adverse reaction(s)
Brentuximab vedotin7  Anti-CD30 ADC R/R CD30+ MF after 1 prior systemic therapy 65.6% ≤IIA: 53%
IIB: 68%
IIA-IIIB: 75%
IVA: 100% (2/2)c
IVB: 57% 
Peripheral sensory and motor neuropathy 
Mogamulizumab8  Anti-CCR4 Ab R/R MF/SS after 1 prior systemic therapy MF: 21%
SS: 37% 
Skin: 42%
Node: 17%
Blood: 68%
Viscera: 0%d 
Infusion-related reaction, rash (see text for discussion) 
E777740  Recombinant IL2-diptheria toxin protein R/R MF/SS after 1 prior systemic therapy 36.2% — Infusion-related reaction, capillary leak syndrome, visual impairment 
Lacutamab14-16  Anti-KIR3DL2 Ab No SS: 37.5%e Skin: 46.4%
Node: 19.6%
Blood: 48.2%
Viscera: NR 
Peripheral edema 
Pembrolizumab17  Anti–PD-1 therapy No (NCCN) 38% IB: 0% (0/1)
IIB: 100% (2/2)
IIIA: 100% (2/2)
IIIB: 33% (1/3)
IVA: 25% (4/16) 
Rash/flare, immune-related toxicity 
Tislelizumab41
 
Anti–PD-1 therapy No 46% — Rash/flare, immune-related toxicity (observed in only 1 patient with SS in study, recovered within 4 days) 
DR-01 (NCT05475925) Anti-CD94 Ab targeting cytotoxic TCLs, including MF, PCAETCL, PCGDTCL No Ongoing study, with data to be reported 
a

This column refers to approval status with the United Stated Food and Drug Administration (FDA).

b

Response rates in MF/SS are highly nuanced and depend on the response criteria used as well as disease stage, type of lesion (ie, patch, plaque, or tumor), and compartment (ie, skin, blood, lymph nodes, or organ). We encourage direct consultation with the referenced publication to review response rates in detail.

c

Note that B2 blood involvement was not eligible for the ALCANZA trial.7 

d

Note that only 3 patients with visceral disease received mogamulizumab.7 

e

Results in this row show data from lacutamab use in the SS cohort of the TELLOMAK train. (Not shown are results from the MF cohort.)

Ab, antibody; ADC, antibody-drug conjugate; CR, complete response; KIR3DL2, killer cell immunoglobulin-like receptor 3DL2; MF, mycosis fungoides; NCCN, National Comprehensive Cancer Network; NR, not reported; TTNT, time to next treatment.

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