Table 4.
Summary of safety and grade ≥3 TEAEs regardless of causality reported by at least 5% of patients with PDAC (safety population).
| Nadunolimab dose | 1.0 mg/kg (N = 20) n (%) | 2.5 mg/kg (N = 20) n (%) | 5.0 mg/kg (N = 28) n (%) | 7.5 mg/kg (N = 8) n (%) | Total (N = 76) n (%) |
|---|---|---|---|---|---|
| TEAE | |||||
| Any TEAE | 20 (100) | 20 (100) | 28 (100) | 8 (100) | 76 (100) |
| Grade 3/4 | 17 (85) | 19 (95) | 24 (86) | 8 (100) | 68 (89) |
| Grade 5 | — | 1 (5) | 1 (4) | 1 (13) | 3 (4) |
| Grade 3/4 TEAEs related to nadunolimab | 13 (65) | 17 (85) | 19 (68) | 8 (100) | 57 (75) |
| Any TESAE | 9 (45) | 11 (55) | 22 (79) | 2 (25) | 44 (58) |
| DLT | — | — | — | 1 (13) | 1 (1) |
| TEAEs leading to study discontinuations | 2 (10) | 2 (10) | 1 (4) | — | 5 (7) |
| Preferred term | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades |
|---|---|---|---|---|---|---|---|---|---|---|
| Neutropenia | 11 (55) | 14 (70) | 14 (70) | 16 (80) | 18 (64) | 21 (75) | 7 (88) | 7 (88) | 50 (66) | 58 (76) |
| Leukopenia | 4 (20) | 6 (30) | 2 (10) | 3 (15) | 10 (36) | 11 (39) | 2 (25) | 2 (25) | 18 (24) | 22 (29) |
| γ-GT increased | 3 (15) | 4 (20) | 7 (35) | 8 (40) | 3 (11) | 4 (14) | — | — | 13 (17) | 16 (21) |
| Anemia | 1 (5) | 13 (65) | 4 (20) | 11 (55) | 6 (21) | 13 (46) | — | 2 (25) | 11 (15) | 39 (51) |
| Thrombocytopenia | 2 (10) | 8 (40) | 2 (10) | 8 (40) | 4 (14) | 9 (32) | 2 (25) | 5 (63) | 10 (13) | 30 (39) |
| Febrile neutropenia | 3 (15) | 3 (15) | 1 (5) | 1 (5) | 5 (18) | 5 (18) | 1 (13) | 1 (13) | 10 (13) | 10 (13) |
| Hypertension | 2 (10) | 3 (15) | 2 (10) | 2 (10) | 2 (7) | 3 (11) | 1 (13) | 2 (25) | 7 (9) | 10 (13) |
| Fatigue | 1 (5) | 9 (45) | 3 (15) | 11 (55) | 2 (7) | 16 (57) | — | 5 (63) | 6 (8) | 41 (54) |
| Alanine aminotransferase increased | 3 (15) | 6 (30) | 1 (5) | 5 (25) | — | 2 (7) | 1 (13) | 1 (13) | 5 (7) | 14 (18) |
| Vomiting | 1 (5) | 8 (40) | 1 (5) | 6 (30) | 2 (7) | 11 (39) | — | 3 (38) | 4 (5) | 28 (37) |
| Dyspnea | 1 (5) | 6 (30) | 1 (5) | 6 (30) | 2 (7) | 7 (25) | — | 1 (13) | 4 (5) | 20 (26) |
| AST increased | 3 (15) | 4 (20) | 1 (5) | 4 (20) | — | 3 (11) | — | 1 (13) | 4 (5) | 12 (16) |
| Aspartate aminotransferase increased | 3 (15) | 4 (20) | 1 (5) | 4 (20) | — | 3 (10) | — | 1 (13) | 4 (5) | 12 (16) |
| Lymphopenia | 1 (5) | 2 (10) | 1 (5) | 2 (10) | 2 (7) | 2 (7) | — | — | 4 (5) | 6 (8) |
| Cholangitis, infective | 1 (5) | 1 (5) | 1 (5) | 1 (5) | 2 (7) | 2 (7) | — | 1 (13) | 4 (5) | 5 (7) |
NOTE: Percentages are based on the number (N) of included subjects. When a subject experienced more than one event in different preferred terms or within the same preferred term, all incidences are counted.
Abbreviations: AST, aspartate aminotransferase; DLT, dose- or treatment-limiting toxicity; GT, glutamyltransferase; n, number of subjects with an event.