Table 1:
Most frequent Treatment-related adverse events (TRAE; shown for both any grade and grades≥3) observed in FIH Phase 1 study of tebentafusp split by study arm and also shown as total number
| Treatment-related AEs, | Total (N=84) | |||||
|---|---|---|---|---|---|---|
| All grades n (%) | Grade ≥3 n (%) | |||||
| Arm 1 | Arm 2 | Total | Arm 1 | Arm 2 | Total | |
| Any treatment-related AE | 65 (98) | 18 (100) | 83 (99) | 27 (41) | 9 (50) | 36 (43) |
| CRSa | 50 (60)b | 0 (0) | ||||
| Other CRS-related AEc | 8 (10) | 8 (10) | ||||
| Rashd | 47 (71) | 10 (56) | 57 (68) | 13 (20) | 7 (39) | 22 (26) |
| Pruritus | 43 (65) | 16 (89) | 59 (70) | 0 (0) | 1 (6) | 1 (1) |
| Pyrexia | 35 (53) | 13 (72) | 48 (57) | 3 (4) | 1 (6) | 4 (5) |
| Periorbital edema | 30 (45) | 11 (61) | 41 (49) | 0 (0) | 0 (0) | 0 (0) |
| Fatigue | 35 (53) | 10 (56) | 45 (54) | 0 (0) | 0 (0) | 0 (0) |
| Nausea | 34 (51) | 10 (56) | 44 (52) | 0 (0) | 0 (0) | 0 (0) |
| Hypotension | 21 (32) | 7 (39) | 28 (33) | 6 (9) | 1 (6) | 7 (8) |
| Vomiting | 24 (36) | 10 (56) | 34 (40) | 0 (0) | 0 (0) | 0 (0) |
| Chills | 17 (26) | 9 (50) | 26 (31) | 0 (0) | 0 (0) | 0 (0) |
| Skin exfoliation | 19 (29) | 5 (28) | 24 (29) | 0 (0) | 0 (0) | 0 (0) |
| Dry skin | 18 (27) | 5 (28) | 23 (27) | 0 (0) | 0 (0) | 0 (0) |
| Headache | 16 (24) | 6 (33) | 22 (26) | 0 (0) | 0 (0) | 0 (0) |
| Erythema | 17 (26) | 2 (11) | 19 (23) | 0 (0) | 0 (0) | 0 (0) |
| Lymphopenia | 13 (20) | 4 (22) | 17 (20) | 9 (14) | 2 (11) | 11 (13) |
| Hypophosphatemia | 5 (8) | 3 (17) | 8 (10) | 3 (4) | 2 (11) | 5 (6) |