TABLE 4.
Overview of TEAEs (All‐treated/safety population).
| Isa (n = 33) | Isa + CemiQ2W (n = 37) | Isa + CemiQ4W (n = 35) | |
|---|---|---|---|
| Patients with any TEAE | 33 (100) | 36 (97.3) | 33 (94.3) |
| Patients with any Grade ≥3 TEAE | 17 (51.5) | 20 (54.1) | 23 (65.7) |
| Patients with any Grade 3–4 TEAE | 17 (51.5) | 18 (48.6) | 21 (60.0) |
| Patients with any Grade 5 TEAE a | 1 (3.0) | 2 (5.4) | 6 (17.1) |
| Patients with any treatment‐emergent SAE | 17 (51.5) | 17 (45.9) | 21 (60.0) |
| Patients with any TEAE leading to definitive treatment discontinuation b | 0 | 1 (2.7) | 7 (20.0) |
| Patients with any IR of Grade ≥2 | 16 (48.5) | 15 (40.5) | 14 (40.0) |
| Patients with any treatment‐related TEAE c (any grade) | 24 (72.7) | 24 (64.9) | 25 (71.4) |
| Patients with any Grade ≥3 treatment‐related TEAE | 2 (6.1) | 6 (16.2) | 10 (28.6) |
| Patients with any serious treatment‐related TEAE | 2 (6.1) | 4 (10.8) | 9 (25.7) |
Abbreviations: Cemi, cemiplimab; IR, infusion reaction; Isa, isatuximab; Q2W, every 2 weeks; Q4W, every 4 weeks; SAE, serious adverse event; TEAE, treatment‐emergent adverse event.
Grade 5 TEAEs during the on‐treatment period included: Isa−disease progression (n = 1); Isa + CemiQ2W–disease progression (n = 1), multiple organ dysfunction syndrome (n = 1); Isa + CemiQ4W–pulmonary sepsis (n = 1; related to treatment); upper respiratory tract infection (n = 1); euthanasia (n = 1); acute kidney injury/disease progression (n = 1); disease progression (n = 1); septic shock (n = 1).
TEAEs leading to discontinuation included: Isa + CemiQ2W–myalgia (n = 1); Isa + CemiQ4W–encephalomyelitis (n = 1); pulmonary sepsis (n = 1); colon neoplasm (n = 1); upper respiratory tract infection (n = 1); infusion‐related reaction (n = 1); lower respiratory tract infection/septic shock (n = 1); peripheral sensory neuropathy (n = 1).
Treatment‐related TEAEs are TEAEs related to at least one drug of the combination.