Table 5.
Experimental Combinations of Approved Agents in R/R PTCLs
| Agent | Trial | N of PTCLs | ORR (%) | Median DOR (Months) | PFS (Months) 95% CI | OS (Months) 95% CI | Grade ≥3 AEs |
|---|---|---|---|---|---|---|---|
| CR (%) | |||||||
| Romidepsin + pralatrexate61 | I/II | 14 | 71 | 4.29 | 4.4 (1.2-NR) | 12.4 (8.1-NR) | Anemia (29%), Thrombocytopenia (28%), Febrile neutropenia (14%), Mucositis oral (14%), Sepsis (7%) |
| 40 | |||||||
| Romidepsin + oral Azacitidine63 | I | 11 | 73 | Not reached | Not reached | Not reported | Neutropenia (42%), lymphopenia (42%), thrombocytopenia (27%), hypotension (12%), hyponatremia (8%) |
| 55 | |||||||
| Romidepsin + duvelisib64 | I/II | 35 | 51 | 9.1 | 8.8 (NA) | Not reported | Neutropenia (18%), increased ALT/AST (15%), hyponatremia (12%) |
| 17 | |||||||
| Duvelisib + bortezomib64 | I/II | 28 | 32 | 9.3 | 3.5 (NA) | Not reported | Neutropenia (18%), 1 pt with grade 5 Stevens-Johnson syndrome |
| 11 | |||||||
| Romidepsin + lenalidomide79 (NCT02232516) | I/II | 21 | 53 | Not reported | 15.3 weeks | Not reached | Neutropenia (48%), thrombocytopenia (38%), anemia (33%) |
| 10.5 | |||||||
| Romidepsin + carfilzomib + lenalidomide79 | I/II | 17 | 50 | 9.6 weeks | 9.7 weeks | Not reported | Neutropenia and thrombocytopenia in more than 10% of pts |
| 31 | |||||||
| Bortezomib + panobinostat65 | II | 25 | 43 | 5.6 | 2.6 | 9.9 | Thrombocytopenia (68%), neutropenia (40%), diarrhea (20%), asthenia (8%) |
| 22 |
Abbreviations: ORR, objective response rate; CR, complete response; DOR, duration of response; PFS, progression-free survival; OS, overall survival; AE, adverse events.