Summary of best overall response, ORR, and progression-free survival by disease subtype
| . | . | Duvelisib dose (mg, BID), n (%) . | |||||||
|---|---|---|---|---|---|---|---|---|---|
| . | Total . | 8 . | 15 . | 25 . | 35 . | 50 . | 60 . | 75 . | 100 . |
| RR CLL/SLL, n | 55 | 1 | 2 | 28 | 0 | 0 | 0 | 24 | 0 |
| ORR, n (%) | 31 (56) | 1 (100) | 1 (50) | 16 (57) | — | — | — | 13 (54) | — |
| CR | 1 (2) | 0 | 0 | 1 (4) | — | — | — | 0 | — |
| PR | 30 (55) | 1 (100) | 1 (50) | 15 (54) | — | — | — | 13 (54) | — |
| Median months of PFS (95% CI) | 15.7 (5.4-30.2) | ||||||||
| TN CLL, n | 18 | 0 | 0 | 18 | 0 | 0 | 0 | 0 | 0 |
| ORR, n (%) | 15 (83) | — | — | 15 (83) | — | — | — | — | — |
| PR | 15 (83) | — | — | 15 (83) | — | — | — | — | — |
| Median months of PFS (95% CI) | NE (12.7-NE) | ||||||||
| iNHL, n | 31 | 0 | 1 | 14 | 0 | 1 | 0 | 15 | 0 |
| ORR, n (%) | 18 (58) | — | 1 (100) | 9 (64) | — | 1 (100) | — | 7 (47) | — |
| CR | 6 (19) | — | 1 (100) | 4 (29) | — | 0 | — | 1 (7) | — |
| PR | 11 (36) | — | — | 4 (29) | — | 1 (100) | — | 6 (40) | — |
| MR | 1 (3) | — | — | 1 (7) | — | 0 | — | 0 | — |
| Median months of PFS (95% CI) | 14.7 (5.4-30.2) | ||||||||
| aNHL, n* | 26 | 0 | 1 | 1 | 1 | 0 | 0 | 22 | 1 |
| ORR, n (%) | 5 (19) | — | 0 | 0 | 0 | — | — | 5 (23) | 0 |
| CR | 2 (8) | — | 0 | 0 | 0 | — | — | 2 (9) | 0 |
| PR | 3 (12) | — | 0 | 0 | 0 | — | — | 3 (14) | 0 |
| MCL, n | 10 | 0 | 0 | 4 | 0 | 0 | 0 | 6 | 0 |
| ORR n (%) | 5 (50) | — | — | 3 (75) | — | — | — | 2 (33) | — |
| CR | 1 (10) | — | — | 1 (25) | — | — | — | 0 | — |
| PR | 4 (40) | — | — | 2 (50) | — | — | — | 2 (33) | — |
| HL, n | 3 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 |
| ORR, n (%) | 1 (33) | — | — | — | 0 | 1 (100) | — | 0 | — |
| CR | 1 (33) | — | — | — | 0 | 1 (100) | — | 0 | — |
| Cutaneous TCL, n | 19 | 0 | 0 | 1 | 0 | 1 | 2 | 14 | 1 |
| ORR, n (%) | 6 (32) | — | — | 0 | — | 0 | 1 (50) | 5 (36) | 0 |
| PR | 6 (32) | — | — | 0 | — | 0 | 1 (50) | 5 (36) | 0 |
| Median months of PFS (95% CI) | 4.5 (1.0-5.6) | ||||||||
| Peripheral TCL, n | 16 | 0 | 0 | 0 | 0 | 0 | 2 | 13 | 1 |
| ORR, n (%) | 8 (50) | — | — | — | — | — | 1 (50) | 7 (54) | 0 |
| CR | 3 (19) | — | — | — | — | — | 1 (50) | 2 (15) | 0 |
| PR | 5 (31) | — | — | — | — | — | 1 (50) | 2 (15) | 0 |
| Median months of PFS (95% CI) | 4.4 (0.7-NE) | ||||||||
| AML, n | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 0 |
| ORR, n (%) | 0 | — | — | — | — | — | — | 0 | — |
| B-cell ALL, n | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 |
| ORR, n (%) | 0 | — | — | — | — | — | — | 0 | — |
| LGL, n | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 |
| ORR, n (%) | 1 (33) | — | — | — | — | — | — | 1 (33) | — |
| PR | 1 (33) | — | — | — | — | — | — | 1 (33) | — |
| MM, n | 3 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
| ORR n (%) | 0 | — | 0 | — | 0 | — | — | — | - |
| MDS, n | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 0 |
| ORR, n (%) | 1 (17) | — | — | — | — | — | — | 1 (17) | — |
| CR | 1 (17) | — | — | — | — | — | — | 1 (17) | — |
| Myelofibrosis, n | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 |
| ORR, n (%) | 1 (20) | — | — | — | — | — | — | 1 (20) | — |
| Clinical Improvement | 1 (20) | — | — | — | — | — | — | 1 (20) | — |
| T-cell ALL, n | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 |
| ORR, n (%) | 1 (20) | — | — | — | — | — | — | 1 (20) | — |
| PR | 1 (20) | — | — | — | — | — | — | 1 (20) | — |
| . | . | Duvelisib dose (mg, BID), n (%) . | |||||||
|---|---|---|---|---|---|---|---|---|---|
| . | Total . | 8 . | 15 . | 25 . | 35 . | 50 . | 60 . | 75 . | 100 . |
| RR CLL/SLL, n | 55 | 1 | 2 | 28 | 0 | 0 | 0 | 24 | 0 |
| ORR, n (%) | 31 (56) | 1 (100) | 1 (50) | 16 (57) | — | — | — | 13 (54) | — |
| CR | 1 (2) | 0 | 0 | 1 (4) | — | — | — | 0 | — |
| PR | 30 (55) | 1 (100) | 1 (50) | 15 (54) | — | — | — | 13 (54) | — |
| Median months of PFS (95% CI) | 15.7 (5.4-30.2) | ||||||||
| TN CLL, n | 18 | 0 | 0 | 18 | 0 | 0 | 0 | 0 | 0 |
| ORR, n (%) | 15 (83) | — | — | 15 (83) | — | — | — | — | — |
| PR | 15 (83) | — | — | 15 (83) | — | — | — | — | — |
| Median months of PFS (95% CI) | NE (12.7-NE) | ||||||||
| iNHL, n | 31 | 0 | 1 | 14 | 0 | 1 | 0 | 15 | 0 |
| ORR, n (%) | 18 (58) | — | 1 (100) | 9 (64) | — | 1 (100) | — | 7 (47) | — |
| CR | 6 (19) | — | 1 (100) | 4 (29) | — | 0 | — | 1 (7) | — |
| PR | 11 (36) | — | — | 4 (29) | — | 1 (100) | — | 6 (40) | — |
| MR | 1 (3) | — | — | 1 (7) | — | 0 | — | 0 | — |
| Median months of PFS (95% CI) | 14.7 (5.4-30.2) | ||||||||
| aNHL, n* | 26 | 0 | 1 | 1 | 1 | 0 | 0 | 22 | 1 |
| ORR, n (%) | 5 (19) | — | 0 | 0 | 0 | — | — | 5 (23) | 0 |
| CR | 2 (8) | — | 0 | 0 | 0 | — | — | 2 (9) | 0 |
| PR | 3 (12) | — | 0 | 0 | 0 | — | — | 3 (14) | 0 |
| MCL, n | 10 | 0 | 0 | 4 | 0 | 0 | 0 | 6 | 0 |
| ORR n (%) | 5 (50) | — | — | 3 (75) | — | — | — | 2 (33) | — |
| CR | 1 (10) | — | — | 1 (25) | — | — | — | 0 | — |
| PR | 4 (40) | — | — | 2 (50) | — | — | — | 2 (33) | — |
| HL, n | 3 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 |
| ORR, n (%) | 1 (33) | — | — | — | 0 | 1 (100) | — | 0 | — |
| CR | 1 (33) | — | — | — | 0 | 1 (100) | — | 0 | — |
| Cutaneous TCL, n | 19 | 0 | 0 | 1 | 0 | 1 | 2 | 14 | 1 |
| ORR, n (%) | 6 (32) | — | — | 0 | — | 0 | 1 (50) | 5 (36) | 0 |
| PR | 6 (32) | — | — | 0 | — | 0 | 1 (50) | 5 (36) | 0 |
| Median months of PFS (95% CI) | 4.5 (1.0-5.6) | ||||||||
| Peripheral TCL, n | 16 | 0 | 0 | 0 | 0 | 0 | 2 | 13 | 1 |
| ORR, n (%) | 8 (50) | — | — | — | — | — | 1 (50) | 7 (54) | 0 |
| CR | 3 (19) | — | — | — | — | — | 1 (50) | 2 (15) | 0 |
| PR | 5 (31) | — | — | — | — | — | 1 (50) | 2 (15) | 0 |
| Median months of PFS (95% CI) | 4.4 (0.7-NE) | ||||||||
| AML, n | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 0 |
| ORR, n (%) | 0 | — | — | — | — | — | — | 0 | — |
| B-cell ALL, n | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 |
| ORR, n (%) | 0 | — | — | — | — | — | — | 0 | — |
| LGL, n | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 |
| ORR, n (%) | 1 (33) | — | — | — | — | — | — | 1 (33) | — |
| PR | 1 (33) | — | — | — | — | — | — | 1 (33) | — |
| MM, n | 3 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
| ORR n (%) | 0 | — | 0 | — | 0 | — | — | — | - |
| MDS, n | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 0 |
| ORR, n (%) | 1 (17) | — | — | — | — | — | — | 1 (17) | — |
| CR | 1 (17) | — | — | — | — | — | — | 1 (17) | — |
| Myelofibrosis, n | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 |
| ORR, n (%) | 1 (20) | — | — | — | — | — | — | 1 (20) | — |
| Clinical Improvement | 1 (20) | — | — | — | — | — | — | 1 (20) | — |
| T-cell ALL, n | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 |
| ORR, n (%) | 1 (20) | — | — | — | — | — | — | 1 (20) | — |
| PR | 1 (20) | — | — | — | — | — | — | 1 (20) | — |
Percentages are based on the number of patients in each dose group.
DLBCL, diffuse large B-cell lymphoma; FL = follicular lymphoma; HL = Hodgkin lymphoma; MR = minor response; NE, not estimable; PFS = progression-free survival; PR = partial response.
aNHL includes the subtypes of Richter transformation (n = 9), DLBCL (n = 14), transformed FL (n = 2), and DLBCL transformation (n = 1).