Table 2.
Treatment-Related Adverse Events
| Incidence, n (%) | Part A Vidutolimod + Atezolizumab n = 13 |
Part B Vidutolimod + Atezolizumab + RT n = 16 |
||||
|---|---|---|---|---|---|---|
| Any Grade | Grade 3 | Grade 4 | Any Grade | Grade 3 | Grade 4 | |
| Patients with ≥1 TRAE | 13 (100.0) | 4 (30.8) | 2 (15.4) | 14 (87.5) | 7 (43.8) | 1 (6.3) |
| TRAEs with ≥15% incidence in any parta | ||||||
| Pyrexia | 6 (46.2) | 0 | 0 | 9 (56.3) | 1 (6.3) | 0 |
| Hypotension | 5 (38.5) | 1 (7.7) | 0 | 9 (56.3) | 4 (25.0) | 0 |
| Chills | 4 (30.8) | 0 | 0 | 6 (37.5) | 1 (6.3) | 0 |
| Fatigue | 3 (23.1) | 1 (7.7) | 0 | 3 (18.8) | 0 | 0 |
| Anemia | 1 (7.7) | 0 | 0 | 5 (31.3) | 2 (12.5) | 0 |
| Headache | 4 (30.8) | 0 | 0 | 1 (6.3) | 0 | 0 |
| Hypophosphatemia | 2 (15.4) | 1 (7.7) | 0 | 3 (18.8) | 0 | 0 |
| Injection site pain | 2 (15.4) | 0 | 0 | 2 (12.5) | 0 | 0 |
| Injection site reaction | 2 (15.4) | 0 | 0 | 2 (12.5) | 0 | 0 |
| Platelet count decreased | 1 (7.7) | 0 | 0 | 3 (18.8) | 0 | 0 |
| Tachycardia | 2 (15.4) | 0 | 0 | 2 (12.5) | 1 (6.3) | 0 |
| Hypokalemia | 1 (7.7) | 0 | 0 | 2 (12.5) | 1 (6.3) | 1 (6.3) |
| Back pain | 2 (15.4) | 1 (7.7) | 0 | 0 | 0 | 0 |
| Dyspnea | 2 (15.4) | 2 (15.4) | 0 | 0 | 0 | 0 |
| Injection site rash | 2 (15.4) | 0 | 0 | 0 | 0 | 0 |
| Pneumonitis | 2 (15.4) | 1 (7.7) | 0 | 0 | 0 | 0 |
Note: No treatment-related deaths were reported.
RT, radiation therapy; TRAE, treatment-related adverse event.
a
Or ≥2 patients of grade ≥3 in any part.