Immune-related AEs
| Immune-related AE, n (%) | All patients (n=133) | PD-1–naïve patients (n=46) | ||||
| All grades | Grade 1/2 | Grade ≥3 | All grades | Grade 1/2 | Grade ≥3 | |
| Rash | 15 (11.3) | 13 (9.8) | 2 (1.5) | 7 (15.2) | 6 (13.0) | 1 (2.2) |
| Thyroid | 10 (7.5) | 10 (7.5) | 0 | 5 (10.9) | 5 (10.9) | 0 |
| Arthralgia | 9 (6.8) | 9 (6.8) | 0 | 3 (6.5) | 3 (6.5) | 0 |
| Diarrhea | 8 (6.0) | 7 (5.3) | 1 (0.8) | 4 (8.7) | 4 (8.7) | 0 |
| Hepatic | 8 (6.0) | 8 (6.0) | 0 | 0 | 0 | 0 |
| Pneumonitis | 8 (6.0) | 5 (3.8) | 3 (2.3) | 3 (6.5) | 2 (4.3) | 1 (2.2) |
| Anemia | 7 (5.3) | 6 (4.5) | 1 (0.8) | 0 | 0 | 0 |
| Lymphopenia | 7 (5.3) | 1 (0.8) | 6 (4.5) | 3 (6.5) | 1 (2.2) | 2 (4.3) |
| Colitis | 3 (2.3) | 3 (2.3) | 0 | 1 (2.2) | 1 (2.2) | 0 |
| Adrenal insufficiency | 2 (1.5) | 1 (0.8) | 1 (0.8) | 2 (4.3) | 1 (2.2) | 1 (2.2) |
| Myalgia | 2 (1.5) | 2 (1.5) | 0 | 1 (2.2) | 1 (2.2) | 0 |
| Myocarditis | 2 (1.5) | 1 (0.8) | 1 (0.8) | 0 | 0 | 0 |
| Pancreatitis | 1 (0.8) | 1 (0.8) | 0 | 0 | 0 | 0 |
| Thrombocytopenia | 1 (0.8) | 1 (0.8) | 0 | 0 | 0 | 0 |
| Total | 83 (62.4) | 68 (51.1) | 15 (11.3) | 29 (63.0) | 24 (52.2) | 5 (10.9) |
Immune-related AEs were defined as AEs determined by the investigator to be treatment related and that have been traditionally classified as immune-related AEs in the context of immuno-oncology agents.
No MTD was defined; thus, the MAD of 15 mg/kg of enoblituzumab was administered weekly during cohort expansion.
AE, adverse event; MAD, maximum administered dose; MTD, maximum tolerated dose; PD-1, programmed cell death-1; TRAE, treatment-related adverse event.