TABLE 5.
Summary of TEAEs occurring in at least 15% of patients (All‐treated/safety population).
| Isa (n = 33) | Isa + CemiQ2W (n = 37) | Isa + CemiQ4W (n = 35) | ||||
|---|---|---|---|---|---|---|
| All grades | Grade ≥3 | All grades | Grade ≥3 | All grades | Grade ≥3 | |
| Infections and infestations | 19 (57.6) | 8 (24.2) | 20 (54.1) | 9 (24.3) | 23 (65.7) | 9 (25.7) |
| Upper respiratory tract infection | 4 (12.1) | 1 (3.0) | 4 (10.8) | 0 | 9 (25.7) | 2 (5.7) |
| Gastrointestinal disorders | 11 (33.3) | 3 (9.1) | 16 (43.2) | 2 (5.4) | 13 (37.1) | 4 (11.4) |
| Diarrhea | 6 (18.2) | 1 (3.0) | 7 (18.9) | 0 | 7 (20.0) | 2 (5.7) |
| Nausea | 5 (15.2) | 0 | 6 (16.2) | 1 (2.7) | 5 (14.3) | 0 |
| Musculoskeletal and connective tissue disorders | 17 (51.5) | 2 (6.1) | 15 (40.5) | 1 (2.7) | 10 (28.6) | 5 (14.3) |
| Back pain | 4 (12.1) | 1 (3.0) | 6 (16.2) | 0 | 4 (11.4) | 2 (5.7) |
| General disorders and administration site conditions | 15 (45.5) | 2 (6.1) | 18 (48.6) | 4 (10.8) | 10 (28.6) | 3 (8.6) |
| Fatigue | 3 (9.1) | 0 | 8 (21.6) | 0 | 5 (14.3) | 1 (2.9) |
| Pyrexia | 4 (12.1) | 0 | 8 (21.6) | 1 (2.7) | 2 (5.7) | 1 (2.9) |
| Injury, poisoning, and procedural complications | 20 (60.6) | 0 | 15 (40.5) | 0 | 17 (48.6) | 0 |
| Infusion‐related reaction | 18 (54.5) | 0 | 15 (40.5) | 0 | 16 (45.7) | 0 a |
Abbreviations: Cemi, cemiplimab; Isa, isatuximab; Q2W, every 2 weeks; Q4W, every 4 weeks.
a
One patient in the Isa + CemiQ4W arm experienced a Grade 3 infusion reaction leading to hospitalization and investigational medicine product discontinuation, which was mistakenly reported as a Grade 2 infusion reaction.