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Table 1 Licensed agents in PTCL

From: Biomarker-driven management strategies for peripheral T cell lymphoma

Agent Target Trial/phase Subtype N ORR (%), CR (%) Median DOR (months) Median PFS(months) Median OS (months) AEs
Frontline Brentuximab vedotin + CHP, “BV-CHP” Anti-CD30 Ab-drug conjugate ECHELON-2 multinational phase III [70]
BV-CHP vs. CHOP
CD30+ PTCL, ALCL 72% (ALK+22%, ALK− 50%), PTCL-NOS 13%, AITL 13% 226 83, 68 Not reported 48.2 Not reached after 3 years follow-up, 34% risk of death reduction Increased diarrhea, any grade (38% vs 20%) in BV-CHP vs CHOP, other AEs comparable between two cohorts
Relapsed/refractory Brentuximab vedotin Anti-CD30 Ab-drug conjugate Multinational phase II [15] ALCL, ALK+ 28%, ALK− 72% 58 86, 57 12.6 20, 57% at 5 years Not reached,79% at 5 years Grade ≥ 3 AEs: neutropenia (21%), thrombocytopenia (14%), peripheral sensory neuropathy (12%)
Multinational phase II [16] CD30+ PTCL, PTCL-NOS 63%, AITL 37% 35 41, 24 7.6 2.6 Not reported Grade ≥ 3 AEs: neutropenia (14%), peripheral sensory neuropathy (9%), and hyperkalemia (9%)
Romidepsin HDAC-1 inhibitor Multinational phase II [30] PTCL, PTCL-NOS 53%, AITL 21%, ALCL, ALK− 16% 130 25, 15 28 4 11.3 Grade ≥ 3 AEs: thrombocytopenia (24%), neutropenia (20%), infections (all types, 19%)
Belinostat Pan-HDAC inhibitor BELIEF multinational phase II [35] PTCL, PTCL-NOS 64%, ATIL 18%, ALCL 14% (ALK+ 2%, ALK− 12%), EATL 2%, ENKTL 2%, HSTCL 2% 129 25.8,10.8 13.6 1.6 7.9 Grade ≥ 3 AEs: anemia (10.8%), thrombocytopenia (7%), dyspnea (6.2%), neutropenia (6.2%)
Chidamide* HDAC class I/II inhibitor Chinese phase II [36] PTCL, PTCL-NOS 35%, ALCL 22% (ALK− 14% ALK+ 4%, ALK unk. 4%), NKTCL 20%, AITL 13% 79 28, 14 9.9 2.1 21.4 Grade ≥ 3 AEs: thrombocytopenia (22%), leukopenia (13%), neutropenia (11%)
Pralaxtrexate Antifolate PROPEL North American phase II [66] PTCL 109 29, 11 10.5 3.5 14.5 Grade ≥ 3 AEs: thrombocytopenia (32%), mucositis (22%), neutropenia (22%), anemia (18%)
Mogamulizumab¥ Anti-CCR4 mAb Japanese phase II [27] CCR4+ R/R ATLL, acute 54%, lymphomatous 23%, chronic 23% 26 50, 31 Not reported 5.2 14.4, 23% at 3 years All grades: infusion reactions (89%) skin rash (63%, 1 Stevens-Johnson syndrome)
Skin rash appears to correlated with response
  Japanese phase II [86] CCR4+ (≥ 10% by IHC), relapsed PTCL (no refractory pts), PTCL-NOS 55%, AITL 41%, ALCL, ALK− 3% 29 34, 13.5 Not reported 2 14.2 Grade ≥ 3 AEs: lymphopenia (81%), neutropenia (38%), leukopenia (43%)
Skin rash (all grades), 51%; grade ≥ 3, 11%
  1. Licensed by FDA unless otherwise noted
  2. *Approved in China
  3. ¥Approved in Japan