Table 4.
Phase II Study Results From United States Supporting Prescribing Information for Agents Approved for Relapsed or Refractory PTCL
| Result | Belinostat | Pralatrexate | Romidepsin | Brentuximab Vedotin* |
|---|---|---|---|---|
| No. of patients (response evaluable of those enrolled) | 120 of 129 | 109 of 111 | 130 of 131 | 58 of 58* |
| Central review of response | Yes | Yes | Yes | Yes |
| ORR | 26% (CR + PR) | 27% (CR + CRu + PR) | 26% (CR + CRu + PR) | 86% (CR + PR)* |
| Nonhematologic AEs† | Nausea (42%) | Mucositis (70%) | Nausea (59%) | Peripheral sensory neuropathy (53%) |
| Fatigue (37%) | Nausea (40%) | Asthenia/fatigue (55%) | Fatigue (41%) | |
| Pyrexia (35%) | Fatigue (36%) | Vomiting (39%) | Nausea (38%) | |
| Vomiting (29%) | Constipation (33%) | Diarrhea (36%) | Pyrexia (38%) | |
| Constipation (23%) | Pyrexia (32%) | Pyrexia (35%) | Rash (31%) | |
| Diarrhea (23%) | Edema (30%) | Constipation (30%) | Pain (28%) | |
| Dyspnea (22%) | Cough (28%) | Anorexia (28%) | Diarrhea (29%) | |
| Rash (20%) | Epistaxis (26%) | Dysgeusia (21%) | ||
| Peripheral edema (20%) | Vomiting (25%) | |||
| Diarrhea (21%) | ||||
| Hematologic AEs‡ | Anemia (32%) | Thrombocytopenia (41%) | Thrombocytopenia (41%) | Neutropenia (55%) |
| Thrombocytopenia (16%) | Anemia (34%) | Neutropenia (30%) | Anemia (52%) | |
| Neutropenia (24%) | Anemia (25%) | Thrombocytopenia (16%) | ||
| Leukopenia (11%) | Leukopenia (12%) | |||
| Warning or precaution | ||||
| Myelosuppression | X | X | X | X |
| Infection | X | X | X | |
| Hepatotoxicity | X | X | ||
| Tumor lysis syndrome | X | X | X | |
| GI toxicity | X | |||
| Mucositis | X | |||
| Folic acid or vitamin B12 required | X | |||
| Renal toxicity | X | |||
| ECG changes | X | |||
| Peripheral neuropathy | X | |||
| Infusion reactions | X | |||
| Stevens-Johnson syndrome | X | |||
| PML | X (boxed warning)§ |
Abbreviations: AE, adverse event; CR, complete response; CRu, complete response unconfirmed; ORR, overall response rate; PML, progressive multifocal leukoencephalopathy; PR, partial response; PTCL, peripheral T-cell lymphoma.
*
Patients with anaplastic large-cell lymphoma only.
†
All grades; occurring in ≥ 20% of patients.
‡
Occurring in ≥ 10% of patients.
§
Complete boxed warning states John Cunningham virus infection resulting in PML and death can occur in patients.