Summary of tumor response, PFS, DOR, and OS in the efficacy analysis set
| Cohort . | AITL (n = 32) . | PTCL-NOS (n = 24) . | Other∗ (n = 2) . | Total† (N = 58) . |
|---|---|---|---|---|
| Primary: ORR (CR + PR), % (n; 95% CI; P value) | 56.3 (18; 39.3, 71.8; P < .001) | 20.8 (5; 9.2, 40.5; P = .077) | 0 (0; 0.0, 84.2; P = 1.000) | 39.7 (23; 28.1, 52.5; P < .001) |
| CR, n (%) | 9 (28.1) | 1 (4.2) | 0 | 10 (17.2) |
| PR, n (%) | 9 (28.1) | 4 (16.7) | 0 | 13 (22.4) |
| Stable disease, n (%) | 3 (9.4) | 9 (37.5) | 0 | 12 (20.7) |
| Progressive disease, n (%) | 11 (34.4) | 9 (37.5) | 2 (100) | 22 (37.9) |
| Nonevaluable‡, n (%) | 0 | 1 (4.2) | 0 | 1 (1.7) |
| Secondary: mPFS (mo) (n; 95% CI) | 3.6 (32; 1.9-8.3) | 3.5 (24; 1.8-5.3) | 1.4 (2; 1.1-1.6) | 3.5 (58; 2.1-4.4) |
| mDOR (mo) (n; 95% CI) | 7.8 (18; 2.0-16.3) | 2.0 (5; 1.0 to NA) | NA (0; NA to NA) | 3.7 (23; 2.0-15.3) |
| Exploratory: mOS (mo) (n; 95% CI) | 32.8 (32; 16.7 to NA) | 21.7 (24; 7.0 to NA) | NA (2; 4.7 to NA) | 32.8 (58; 14.4 to NA) |
| Cohort . | AITL (n = 32) . | PTCL-NOS (n = 24) . | Other∗ (n = 2) . | Total† (N = 58) . |
|---|---|---|---|---|
| Primary: ORR (CR + PR), % (n; 95% CI; P value) | 56.3 (18; 39.3, 71.8; P < .001) | 20.8 (5; 9.2, 40.5; P = .077) | 0 (0; 0.0, 84.2; P = 1.000) | 39.7 (23; 28.1, 52.5; P < .001) |
| CR, n (%) | 9 (28.1) | 1 (4.2) | 0 | 10 (17.2) |
| PR, n (%) | 9 (28.1) | 4 (16.7) | 0 | 13 (22.4) |
| Stable disease, n (%) | 3 (9.4) | 9 (37.5) | 0 | 12 (20.7) |
| Progressive disease, n (%) | 11 (34.4) | 9 (37.5) | 2 (100) | 22 (37.9) |
| Nonevaluable‡, n (%) | 0 | 1 (4.2) | 0 | 1 (1.7) |
| Secondary: mPFS (mo) (n; 95% CI) | 3.6 (32; 1.9-8.3) | 3.5 (24; 1.8-5.3) | 1.4 (2; 1.1-1.6) | 3.5 (58; 2.1-4.4) |
| mDOR (mo) (n; 95% CI) | 7.8 (18; 2.0-16.3) | 2.0 (5; 1.0 to NA) | NA (0; NA to NA) | 3.7 (23; 2.0-15.3) |
| Exploratory: mOS (mo) (n; 95% CI) | 32.8 (32; 16.7 to NA) | 21.7 (24; 7.0 to NA) | NA (2; 4.7 to NA) | 32.8 (58; 14.4 to NA) |
ALK, anaplastic lymphoma kinase; mDOR, median DOR; mo, months; mOS, median overall survival; mPFS, median PFS; NA, not applicable; PD, progressive disease; SD, stable disease.
Other includes ALCL ALK-negative and PTCL-subtype not specified per protocol.
Total = 32 AITL + 24 PTCL-NOS + 2 other. A total of 7 patients were not included in the efficacy analysis set because of lack of postbaseline data subsequent to at least 1 dose of study drug.
Nonevaluable: patient was on study for 1 cycle; postdose scan at end of treatment visit was not collected for all lesions.