Table 2.
Overview of TEAEs: all-treated population
| n (%) | EOC (n = 18) | GBM (n = 33) | HCC (n = 27) | SCCHN (n = 29) |
|---|---|---|---|---|
| TEAEs (any grade) | 18 (100) | 33 (100) | 26 (96.3) | 29 (100) |
| TEAEs of grade ≥3 | 5 (27.8) | 16 (48.5) | 11 (40.7) | 12 (41.4) |
| TEAEs of grade 5a | 3 (16.7) | 1 (3.0) | 4 (14.8) | 7 (24.1) |
| Serious TEAEs | 7 (38.9) | 8 (24.2) | 10 (37.0) | 16 (55.2) |
| TRAEsb (any grade) | 18 (100) | 29 (87.9) | 23 (85.2) | 18 (62.1) |
| TRAEs of grade ≥3 | 1 (5.6) | 4 (12.1) | 4 (14.8) | 1 (3.4) |
| Serious TRAEs | 2 (11.1) | 2 (6.1) | 2 (7.4) | 2 (6.9) |
| TEAEs leading to definitive study drug discontinuation | 1 (5.6) | 1 (3.0) | 2 (7.4) | 0 |
| TEAEs leading to premature discontinuation of isatuximab | 0 | 0 | 0 | 0 |
| TEAEs leading to premature discontinuation of atezolizumab | 0 | 0 | 0 | 0 |
| AESIc | 10 (55.6) | 12 (36.4) | 12 (44.4) | 9 (31.0) |
| AESI of grade ≥3 | 0 | 2 (6.1) | 2 (7.4) | 1 (3.4) |
AE, adverse event; AESI, adverse event of special interest; EOC, epithelial ovarian cancer; GBM, glioblastoma; HCC, hepatocellular carcinoma; IAR, infusion-associated reaction; IMP, investigational medicinal product; NIMP, non-investigational medicinal product; SCCHN, squamous cell carcinoma of the head and neck; TEAE, treatment-emergent adverse event; TRAE, TEAE considered by investigators to be related to experimental treatment.
Grade 5 TEAEs were due to disease progression (EOC, n = 3; HCC, n = 3; SCCHN, n = 4) and other TEAEs [GBM: euthanasia (n = 1); HCC: immune-mediated hepatitis (n = 1); SCCHN: acute respiratory failure (n = 1), arterial hemorrhage (n = 1), tumor hemorrhage (n = 1)].
Treatment-related TEAEs were TEAEs related to at least one drug of the combination.
AESI included grade ≥2 IARs, grade ≥3 immune-related TEAEs, immune-related AEs of any grade in a patient previously treated with a phosphoinositide 3-kinase (PI3K) inhibitor (only applicable for patients who received atezolizumab), pregnancy, and symptomatic overdose with IMP/NIMP.