Table 2.
Summary of TRAEs occurring in ≥20% of patients in Cohort 1B-BCR, Cohort 5B-BCR, and all patients with mCRPC
| N (%) | BCR | mCRPC (N=56) | |||||||||||||
| Cohort 1B-BCR (N=20) | Cohort 5B-BCR (N=15) | ||||||||||||||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | |
| Any TRAEs | 7 (35.0) | 6 (30.0) | 5 (25.0) | 1 (5.0) | 19 (95.0) | 3 (20.0) | 2 (13.3) | 6 (40.0) | 3 (20.0) | 15 (100.0) | 15 (26.8) | 13 (23.2) | 17 (30.4) | 5 (8.9) | 51 (91.1) |
| Endocrine disorders | |||||||||||||||
| Hyperthyroidism | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (20.0) | 1 (6.7) | 0 (0.0) | 0 (0.0) | 4 (26.7) | 5 (8.9) | 1 (1.8) | 0 (0.0) | 0 (0.0) | 6 (10.7) |
| Hypothyroidism | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (6.7) | 2 (13.3) | 1 (6.7) | 0 (0.0) | 4 (26.7) | 3 (5.4) | 4 (7.1) | 0 (0.0) | 0 (0.0) | 7 (12.5) |
| Gastrointestinal disorders | |||||||||||||||
| Diarrhea | 2 (10.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 3 (15.0) | 3 (20.0) | 1 (6.7) | 2 (13.3) | 0 (0.0) | 6 (40.0) | 6 (10.7) | 2 (3.6) | 4 (7.1) | 0 (0.0) | 12 (21.4) |
| Nausea | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.0) | 1 (6.7) | 3 (20.0) | 0 (0.0) | 0 (0.0) | 4 (26.7) | 9 (16.1) | 3 (5.4) | 0 (0.0) | 0 (0.0) | 12 (21.4) |
| General disorder and administration site conditions | |||||||||||||||
| Fatigue | 7 (35.0) | 2 (10.0) | 0 (0.0) | 0 (0.0) | 9 (45.0) | 4 (26.7) | 1 (6.7) | 3 (20.0) | 0 (0.0) | 8 (53.3) | 11 (19.6) | 7 (12.5) | 2 (3.6) | 0 (0.0) | 20 (35.7) |
| Influenza-like illness | 9 (45.0) | 3 (15.0) | 0 (0.0) | 0 (0.0) | 12 (60.0) | 3 (20.0) | 1 (6.7) | 1 (6.7) | 0 (0.0) | 5 (33.3) | 9 (16.1) | 2 (3.6) | 0 (0.0) | 0 (0.0) | 11 (19.6) |
| Injection site pain | 6 (30.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 6 (30.0) | 1 (6.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (6.7) | 0 (0.0) | 2 (3.6) | 0 (0.0) | 0 (0.0) | 2 (3.6) |
| Fever | 4 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 7 (12.5) | 1 (1.8) | 0 (0.0) | 0 (0.0) | 8 (14.3) |
| Laboratory investigations | |||||||||||||||
| ALT increased | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.0) | 3 (20.0) | 0 (0.0) | 2 (13.3) | 0 (0.0) | 5 (33.3) | 6 (10.7) | 2 (3.6) | 1 (1.8) | 0 (0.0) | 9 (16.1) |
| Amylase increased | 2 (10.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 3 (15.0) | 5 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 5 (33.3) | 6 (10.7) | 2 (3.6) | 1 (1.8) | 1 (1.8) | 10 (17.9) |
| AST increased | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.0) | 4 (26.7) | 1 (6.7) | 0 (0.0) | 1 (6.7) | 6 (40.0) | 5 (8.9) | 2 (3.6) | 2 (3.6) | 0 (0.0) | 9 (16.1) |
| Lipase increased | 1 (5.0) | 2 (10.0) | 2 (10.0) | 0 (0.0) | 5 (25.0) | 3 (20.0) | 1 (6.7) | 1 (6.7) | 0 (0.0) | 5 (33.3) | 3 (5.4) | 0 (0.0) | 5 (8.9) | 2 (3.6) | 10 (17.9) |
| Metabolism and nutrition disorders | |||||||||||||||
| Hyponatremia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (13.3) | 0 (0.0) | 1 (6.7) | 1 (6.7) | 4 (26.7) | 7 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 7 (12.5) |
| Hypophosphatemia | 0 (0.0) | 0 (0.0) | 4 (20.0) | 0 (0.0) | 4 (20.0) | 0 (0.0) | 0 (0.0) | 1 (6.7) | 0 (0.0) | 1 (6.7) | 0 (0.0) | 3 (5.4) | 0 (0.0) | 0 (0.0) | 3 (5.4) |
| Musculoskeletal and connective tissue disorders | |||||||||||||||
| Arthralgia | 3 (15.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (15.0) | 3 (20.0) | 1 (6.7) | 0 (0.0) | 0 (0.0) | 4 (26.7) | 4 (7.1) | 2 (3.6) | 1 (1.8) | 0 (0.0) | 7 (12.5) |
| Myalgia | 3 (15.0) | 2 (10.0) | 0 (0.0) | 0 (0.0) | 5 (25.0) | 2 (13.3) | 1 (6.7) | 0 (0.0) | 0 (0.0) | 3 (20.0) | 4 (7.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (7.1) |
| Nervous system disorders | |||||||||||||||
| Headache | 3 (15.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (15.0) | 2 (13.3) | 3 (20.0) | 0 (0.0) | 0 (0.0) | 5 (33.3) | 5 (8.9) | 1 (1.8) | 0 (0.0) | 0 (0.0) | 6 (10.7) |
| Skin and subcutaneous tissue disorders | |||||||||||||||
| Pruritus | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.0) | 3 (20.0) | 2 (13.3) | 0 (0.0) | 0 (0.0) | 5 (33.3) | 9 (16.1) | 1 (1.8) | 0 (0.0) | 0 (0.0) | 10 (17.9) |
Safety population. Treatment was received for each cohort. Patients with mCRPC were in Cohorts 1A-mCRPC through 9A-mCRPC and 3B-mCRPC. Treatment included AdC68 vector 4×1011 VP (Cohort 1A-mCRPC only) or 6×1011 VP (all other cohorts), plasmid DNA boosts 5 mg (all cohorts), tremelimumab 40 mg (Cohort 9A-mCRPC only) or 80 mg (all other cohorts), and sasanlimab 130 mg (Cohorts 6A-mCRPC and 9A-mCRPC) or 300 mg (Cohorts 7A-mCRPC and 3B-mCRPC). Patients with BCR in Cohort 1B-BCR were treated with AdC68 vector 6×1011 VP, plasmid DNA boosts 5 mg, and tremelimumab 80 mg. Patients with BCR in Cohort 5B-BCR were treated with AdC68 vector 6×1011 VP, plasmid DNA boosts 5 mg, tremelimumab 80 mg, and sasanlimab 130 mg.
Grade 5 treatment-related AEs occurred in two patients: pulmonary embolism in a patient with mCRPC, and immune-mediated myocarditis in a patient from Cohort 5B-BCR.
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BCR, biochemical recurrence; mCRPC, metastatic castration-resistant prostate cancer; TRAE, treatment-related adverse event; VP, viral particle.