Table 2.
Overview of AEs
| Safety run-in | Extension | Total | |||
|---|---|---|---|---|---|
| MedDRA preferred term, n (%) | Q3W | QW/Q3W | Q3W | QW/Q3W | |
| n = 8 | n = 8 | n = 45 | n = 22 | n = 83 | |
| Patients with at least 1 | |||||
| AE | 8 (100) | 8 (100) | 45 (100) | 22 (100) | 83 (100) |
| AE leading to FAP-IL2v dose modification/interruption | 0 | 1 (12.5) | 7 (15.6) | 7 (31.8) | 15 (18.1) |
| AE leading to treatment discontinuation | 0 | 0 | 1 (2.2) | 0 | 1 (1.2) |
| Serious AE | 4 (50.0) | 3 (37.5) | 24 (53.3) | 10 (45.5) | 41 (49.4) |
| Serious AE related to FAP-IL2v | 2 (25.0) | 1 (12.5) | 14 (31.1) | 8 (36.4) | 25 (30.1) |
| Grade 3 AE | 7 (87.5) | 4 (50.0) | 20 (44.4) | 14 (63.6) | 45 (54.2) |
| Grade 4 AE | 2 (25.0) | 0 | 8 (17.8) | 4 (18.2) | 14 (16.9) |
| AE with fatal outcome | 0 | 0 | 3 ( 6.7) | 1 ( 4.5) | 4 ( 4.8) |
| AE related to FAP-IL2v with fatal outcome | 0 | 0 | 0 | 0 | 0 |
| Most common (in ≥20% total patients) AEs related to FAP-IL2v | Grade | Grade | Grade | Grade | Grade | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | |
| Patients with at least 1 FAP-IL2v-related AE | 1 (12.5) | 7 (87.5) | 4 (50.0) | 3 (37.5) | 45 (100) | 17 (37.8) | 10 (45.5) | 12 (54.5) | 44 (53.0) | 39 (47.0) |
| Pyrexia | 6 (75.0) | 0 | 6 (75.0) | 0 | 19 (42.2) | 1 (2.2) | 12 (54.5) | 0 | 43 (51.2) | 1 (1.2) |
| IRR | 3 (37.5) | 0 | 2 (25.0) | 1 (12.5) | 19 (42.2) | 3 (6.7) | 9 (40.9) | 1 (4.5) | 33 (39.8) | 5 (6.0) |
| Chills | 5 (62.5) | 0 | 4 (50.0) | 0 | 16 (35.6) | 0 | 8 (36.4) | 0 | 33 (39.8) | 0 |
| Nausea | 5 (62.5) | 1 (12.5) | 3 (37.5) | 0 | 13 (28.9) | 1 (2.2) | 7 (31.8) | 0 | 28 (33.3) | 2 (2.4) |
| Aspartate aminotransferase increased | 5 (62.5) | 1 (12.5) | 4 (50.0) | 0 | 12 (26.7) | 2 (4.4) | 4 (18.2) | 1 (4.5) | 25 (29.8) | 4 (4.8) |
| Asthenia | 2 (25.0) | 0 | 4 (50.0) | 0 | 13 (28.9) | 0 | 6 (27.3) | 1 (2.2) | 25 (29.8) | 1 (1.2) |
| Alanine aminotransferase increased | 5 (62.5) | 1 (12.5) | 3 (37.5) | 0 | 11 (24.4) | 2 (4.4) | 1 (4.5) | 2 (9.1) | 20 (23.8) | 5 (6.0) |
| Lymphopenia | 0 | 5 (62.5) | 0 | 2 (25.0) | 0 | 8 (17.8) | 0 | 4 (18.2) | 0 | 19 (22.9) |
| γ-Glutamyltransferase increased | 12 (12.5) | 5 (62.5) | 1 (12.5) | 1 (12.5) | 5 (11.1) | 1 (2.2) | 3 (13.6) | 0 | 10 (11.9) | 7 (8.4) |