Table 2.
Treatment-related adverse events reported in ≥10% of patients (Phase 2 study; safety analysis set).
| Patients with treatment-related adverse events, n (%) | Tepotinib | Sorafenib | ||
|---|---|---|---|---|
| n = 45 | n = 44a | |||
| Any grade | Grade ≥ 3b | Any grade | Grade ≥ 3b | |
| Overall | 37 (82.2) | 13 (28.9) | 43 (97.7) | 20 (45.5) |
| Diarrhoea | 16 (35.6) | 2 (4.4) | 14 (31.8) | 3 (6.8) |
| Oedema peripheral | 11 (24.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Fatigue | 9 (20.0) | 2 (4.4) | 11 (25.0) | 0 (0.0) |
| PPES | 8 (17.8) | 1 (2.2) | 27 (61.4) | 3 (6.8) |
| Decreased appetite | 8 (17.8) | 0 (0.0) | 12 (27.3) | 0 (0.0) |
| Blood creatinine increased | 6 (13.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| AST increased | 5 (11.1) | 2 (4.4) | 10 (22.7) | 3 (6.8) |
| Hypoalbuminaemia | 5 (11.1) | 0 (0.0) | 2 (4.5) | 0 (0.0) |
| ALT increased | 4 (8.9) | 0 (0.0) | 7 (15.9) | 0 (0.0) |
| Amylase increased | 3 (6.7) | 2 (4.4) | 5 (11.4) | 1 (2.3) |
| Blood bilirubin increased | 2 (4.4) | 1 (2.2) | 8 (18.2) | 2 (4.5) |
| Alopecia | 1 (2.2) | 0 (0.0) | 10 (22.7) | 0 (0.0) |
| Lipase increased | 1 (2.2) | 0 (0.0) | 5 (11.4) | 4 (9.1) |
| Hypertension | 0 (0.0) | 0 (0.0) | 11 (25.0) | 6 (13.6) |
| Dermatitis acneiform | 0 (0.0) | 0 (0.0) | 5 (11.4) | 0 (0.0) |
ALT alanine aminotransferase, AST aspartate aminotransferase, PPES palmar–plantar erythrodysesthesia syndrome.
aOne patient did not receive treatment.
bGrade ≥ 3 treatment-related adverse events (in ≥ 2 patients) also included ascites (4.4%) and hyperglycaemia (4.4%) for tepotinib, and increased gamma-glutamyl transferase (4.5%) for sorafenib.