Table 1 Outcomes of clinical trials of novel agents in relapsed or refractory PTCL from 2023 ASH Annual Meeting

Valemetostat

EZH1/2

II

133

AITL (31.6%), PTCL-NOS (30.8%), ALK-negative ALCL (5.3%), ALK-positive ALCL (1.5%), PTCL-TFH (6.0%), other (14.3%)

2

ORR 43.7%, CR 14.3%, PR 29.4%, mDOR 11.9 m

mPFS 5.5 m, mOS 17.0 m

Thrombocytopenia (23.3%), Anemia (18.8%), Neutropenia (17.3%)

302

[3]

HH2853

EZH1/2

Ib

34

AITL (41.2%), PTCL-NOS (32.4%), ALK-negative ALCL (11.8%), NKTCL (5.9%), PTCL-TFH (5.9%), SKIN-PTCL (2.9%)

2

ORR 60.7%, CR 21.4%, PR 39.3%, SD 14.3%, mDOR not reached

mPFS not reached, 3-m PFS rate 74.44%, mOS not reached, 6-m OS rate 91.97%

Thrombocytopenia (14.7%), Neutrophil count decreased (11.8%)

304

[4]

Golidocitinib

JAK1

II

104

PTCL-NOS (57%), AITL (18%), ALCL (11%), NKTCL (3%)

2

ORR 44.3%, CR 24%, PR 20%, SD 19%, mDOR 20.7 m

mPFS 5.6 m, mOS 19.4 m

Neutrophil count decreased (29%), White blood cell count decreased (26%), Lymphocyte count decreased (21%), Thrombocytopenia (20%)

305

[5]

Linperlisib

PI3Kδ

II

98

AITL (49%), PTCL-NOS (24%), NKTCL (8%), ALCL (2%)

2

ORR 48%, CR 30%, PR 18%, SD 20%, mDOR not reached

mPFS 5.5 m, mOS 14.2 m

Neutropenia (32%), Pneumonia (14%), Leukopenia (10%), Anemia (6%), Thrombocytopenia (5%), Upper respiratory tract infection (5%), Lymphocytopenia (5%)

306

[6]

BR101801

PI3K γ/δ and DNA-PK

Ib

26

PTCL-NOS (42%), AITL (42%)

2

ORR 31.6%, CR 21.1%, PR 10.5%, mDOR not reached

mPFS 7.5 m, mOS not reached

AST increased (19.2%), ALT increased (15.4%), Neutropenia (15.4%)

1701

[7]

Lacutamab

KIR3DL2

Ib

10

N/A

3

N/A

N/A

Serum sickness (10%), AST increased (10%)

3072

[8]