Safety summary
| Group 3 cemiplimab 350 mg intravenously Q3W (n=56) | Group 1 cemiplimab 3 mg/kg intravenously Q2W (n=59) | Total (Groups 1+3) (n=115) | ||||
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| Any TEAE, regardless of attribution | 54 (96.4) | 22 (39.3) | 59 (100.0) | 30 (50.8) | 113 (98.3) | 52 (45.2) |
| TEAEs, regardless of attribution, that led to discontinuation | 3 (5.4) | 2 (3.6) | 6 (10.2) | 4 (6.8) | 9 (7.8) | 6 (5.2) |
| Most common TEAEs*, regardless of attribution | ||||||
| Fatigue | 16 (28.6) | 3 (5.4) | 15 (25.4) | 1 (1.7) | 31 (27.0) | 4 (3.5) |
| Diarrhea | 10 (17.9) | 0 (0.0) | 17 (28.8) | 1 (1.7) | 27 (23.5) | 1 (0.9) |
| Nausea | 10 (17.9) | 0 (0.0) | 14 (23.7) | 0 (0.0) | 24 (20.9) | 0 (0.0) |
| Rash | 9 (16.1) | 0 (0.0) | 10 (16.9) | 0 (0.0) | 19 (16.5) | 0 (0.0) |
| Constipation | 7 (12.5) | 0 (0.0) | 10 (16.9) | 1 (1.7) | 17 (14.8) | 1 (0.9) |
| Pruritus | 6 (10.7) | 0 (0.0) | 10 (16.9) | 0 (0.0) | 16 (13.9) | 0 (0.0) |
| Maculopapular rash | 7 (12.5) | 1 (1.8) | 8 (13.6) | 0 (0.0) | 15 (13.0) | 1 (0.9) |
| Anemia | 7 (12.5) | 5 (8.9) | 7 (11.9) | 2 (3.4) | 14 (12.2) | 7 (6.1) |
| Arthralgia | 5 (8.9) | 0 (0.0) | 9 (15.3) | 0 (0.0) | 14 (12.2) | 0 (0.0) |
| Cough | 4 (7.1) | 0 (0.0) | 9 (15.3) | 0 (0.0) | 13 (11.3) | 0 (0.0) |
| Headache | 2 (3.6) | 0 (0.0) | 11 (18.6) | 0 (0.0) | 13 (11.3) | 0 (0.0) |
| Decreased appetite | 4 (7.1) | 0 (0.0) | 8 (13.6) | 0 (0.0) | 12 (10.4) | 0 (0.0) |
| Hypothyroidism | 6 (10.7) | 0 (0.0) | 6 (10.2) | 0 (0.0) | 12 (10.4) | 0 (0.0) |
| Vomiting | 6 (10.7) | 0 (0.0) | 6 (10.2) | 0 (0.0) | 12 (10.4) | 0 (0.0) |
| Peripheral edema | 6 (10.7) | 0 (0.0) | 4 (6.8) | 0 (0.0) | 10 (8.7) | 0 (0.0) |
| Upper respiratory tract infection | 3 (5.4) | 0 (0.0) | 6 (10.2) | 0 (0.0) | 9 (7.8) | 0 (0.0) |
| Dizziness | 1 (1.8) | 0 (0.0) | 7 (11.9) | 0 (0.0) | 8 (7.0) | 0 (0.0) |
| Dry skin | 2 (3.6) | 0 (0.0) | 6 (10.2) | 0 (0.0) | 8 (7.0) | 0 (0.0) |
| Pneumonitis | 2 (3.6) | 0 (0.0) | 6 (10.2) | 3 (5.1) | 8 (7.0) | 3 (2.6) |
| Dyspnea | 1 (1.8) | 0 (0.0) | 6 (10.2) | 2 (3.4) | 7 (6.1) | 2 (1.7) |
| Oropharyngeal pain | 0 (0.0) | 0 (0.0) | 6 (10.2) | 0 (0.0) | 6 (5.2) | 0 (0.0) |
| Treatment-related† | 36 (64.3) | 7 (12.5) | 46 (78.0) | 9 (15.3) | 82 (71.3) | 16 (13.9) |
Data are number of patients (%).
*Adverse events reported in ≥10% of patients in either treatment group are presented, ordered by frequency in both groups combined.
†See online supplement for additional details on treatment-related adverse events.
Q2W, every 2 weeks; Q3W, every 3 weeks; TEAEs, treatment-emergent adverse events.