Table 3.
Efficacy by Disease Subtype.
| Histology | Arm A | Arm B | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Romidepsin + Duvelisib | Bortezomib + Duvelisib | |||||||||||||||
| All Patients | at MTD only | All Patients | at MTD only | |||||||||||||
| Evaluable | ORR | CRR | PRR | Evaluable | ORR | CRR | PRR | Evaluable | ORR | CRR | PRR | Evaluable | ORR | CRR | PRR | |
| n | % (n) | % (n) | % (n) | n | % (n) | % (n) | % (n) | n | % (n) | % (n) | % (n) | n | % (n) | % (n) | % (n) | |
| Peripheral T-cell Lymphoma | 53 | 58 (31) | 42 (22) | 17 (9) | 48 | 56 (27) | 44 (21) | 13 (6) | 16 | 44 (7) | 25 (4) | 19 (3) | 12 | 42 (5) | 17 (2) | 25 (3) |
| PTCL-NOS | 18 | 50 (9) | 28 (5) | 22 (4) | 17 | 47 (8) | 29 (5) | 18 (3) | 7 | 57 (4) | 29 (2) | 29 (2) | 6 | 50 (3) | 17 (1) | 33 (2) |
| AITL/PTCL-TFH | 20 | 70 (14) | 60 (12) | 10 (2) | 17 | 71 (12) | 65 (11) | 6 (1) | 4 | 75 (3) | 50 (2) | 25 (1) | 2 | 100 (2) | 50 (1) | 50 (1) |
| ALCL | 3 | 100 (3) | 67 (2) | 33 (1) | 3 | 100 (3) | 67 (2) | 33 (1) | 2 | 0 | - | - | 1 | 0 | - | - |
| pcGDTCL | 3 | 33 (1) | 33 (1) | - | 3 | 33 (1) | 33 (1) | - | - | - | - | - | - | - | - | |
| HSTCL | 2 | 50 (1) | - | 50 (1) | 1 | 0 | - | - | - | - | - | - | - | - | - | |
| MEITL | 1 | 0 | - | - | 1 | 0 | - | - | - | - | - | - | - | - | - | |
| Aggressive Epidermotropic CD8+ TCL | 2 | 50 (1) | 50 (1) | - | 2 | 50 (1) | 50 (1) | - | - | - | - | - | - | - | - | |
| Other | 4 | 50 (2) | 25 (1) | 25 (1) | 4 | 50 (2) | 25 (1) | 25 (1) | 3 | 0 | - | - | 3 | 0 | - | - |
| T-PLL | 1 | 0 | - | - | 1 | 0 | - | - | 1 | 0 | - | - | 1 | 0 | - | - |
| ATLL | 1 | 0 | - | - | 1 | 0 | - | - | 1 | 0 | - | - | 1 | 0 | - | - |
| pcPTCL | 1 | 100 (1) | - | 100 (1) | 1 | 100 (1) | - | 100 (1) | - | - | - | - | - | - | - | - |
| PTLD | 1 | 100 (1) | 100 (1) | - | 1 | 100 (1) | 100 (1) | - | - | - | - | - | - | - | - | - |
| ENNK/TCL | 0 | - | - | - | 0 | - | - | - | 1 | 0 | - | - | 1 | 0 | - | - |
| Cutaneous T-cell Lymphoma | 11 | 36 (4) | 0 | 36 (4) | 9 | 44 (4) | 0 | 44 (4) | 16 | 25 (4) | 0 | 25 (4) | 11 | 18 (2) | 0 | 18 (2) |
| MF | 7 | 29 (2) | - | 29 (2) | 5 | 40 (2) | - | 40 (2) | 9 | 11 (1) | - | 11 (1) | 7 | 14 (1) | - | 14 (1) |
| - Transformed | 3 | 0 | - | - | 1 | 0 | - | - | 4 | 0 | - | 2 | 0 | - | - | |
| SS | 4 | 50 (2) | - | 50 (2) | 4 | 50 (2) | - | 50 (2) | 7 | 43 (3) | - | 43 (3) | 4 | 25 (1) | - | 25 (1) |
| - Transformed | 1 | 0 | - | 1 | 0 | - | - | 2 | 0 | - | 2 | 0 | - | - | ||
| TOTAL | 64 | 55 (35) | 34 (22) | 20 (13) | 57 | 54 (31) | 37 (21) | 18 (10) | 32 | 34 (11) | 13 (4) | 22 (7) | 23 | 30 (7) | 9 (2) | 22 (5) |
PTCL-NOS, peripheral T-cell lymphoma not otherwise specified; AITL, angioimmunoblastic T-cell lymphoma, Tfh, T-follicular helper; ALCL, anaplastic large cell lymphoma; pcGDTCL, primary cutaneous gamma-delta T-cell lymphoma; HSTCL, hepatosplenic T-cell lymphoma; MEITL, monomorphic epitheliotrophic intestinal T-cell lymphoma; T-PLL, T-prolymphocytic leukemia; ATLL, acute T-cell leukemia/lymphoma; PTLD, peripheral T-cell lymphoproliferative disorder; EN-NK/TCL, extranodal natural killer/T-cell lymphoma; MF, mycosis fungoides; SS, Sezary syndrome.