Table 1.
Adverse events to tilsotolimod + ipilimumab (N = 62)
| Characteristic | Patients, n (%) |
|---|---|
| Patients with at least one TEAE | 61 (98.4) |
| Patients with at least one grade 3/4 TEAE | 30 (48.4) |
| Patients with at least one SAE | 20 (32.3) |
| Patients with at least one immune-related TEAE | 16 (25.8) |
| Patients discontinuing tilsotolimod due to TEAEs | 3 (4.8) |
| Patients discontinuing ipilimumab due to TEAEs | 6 (9.7) |
| Patients discontinuing tilsotolimod due to immune-related TEAEs | 4 (6.5) |
| Patients discontinuing ipilimumab due to immune-related TEAEs | 3 (4.8) |
| Most common TEAEsa | |
| Fatigue | 32 (51.6) |
| Nausea | 25 (40.3) |
| Anemia | 24 (38.7) |
| Diarrhea | 23 (37.1) |
| Pyrexia | 22 (35.5) |
| ALT increased | 20 (32.3) |
| Vomiting | 19 (30.6) |
| Headache | 18 (29.0) |
| Rash | 17 (27.4) |
| AST increased | 16 (25.8) |
| Chills | 16 (25.8) |
| Most common grade 3/4 TEAEsb | |
| Diarrhea | 4 (6.5) |
| ALT increased | 4 (6.5) |
| AST increased | 4 (6.5) |
| Colitisc | 4 (6.5) |
| Fatigue | 3 (4.8) |
| Most common immune-related TEAEsd | |
| Hypophysitis | 5 (8.1) |
| Rash | 5 (8.1) |
| Colitisc | 4 (6.5) |
| ALT increased | 4 (6.5) |
| AST increased | 4 (6.5) |
| Diarrhea | 4 (6.5) |
| Hepatitise | 3 (4.8) |
| Most common grade 3/4 immune-related TEAEsd | |
| Colitisc | 3 (4.8) |
| ALT increased | 3 (4.8) |
| AST increased | 3 (4.8) |
| Hepatitise | 2 (3.2) |
| Hypophysitis | 2 (3.2) |
| Diarrhea | 2 (3.2) |
Abbreviation: SAE, severe adverse effect.
a
TEAEs that occurred in ≥25% of patients are shown and are listed in order of decreasing frequency.
b
Grade 3 or 4 TEAEs that occurred in ≥3 patients are shown and are listed in order of decreasing frequency.
c
Includes preferred terms of colitis, autoimmune colitis, and enterocolitis.
d
Includes events that occurred in ≥3. Immune-related AEs were identified during a sponsor review following database lock that was confirmed with the investigators.
e
Includes patients with immune-related hepatitis or autoimmune hepatitis.