Table 2

Overview of TEAEs—all-treated population

n (%)mCRPC
(n=24)
NSCLC
(n=20)
Patients with any TEAE (any grade)24 (100)20 (100)
Patients with any TEAE of grade ≥313 (54.2)12 (60.0)
Patients with any TEAE of grade 52 (8.3)2 (10.0)
Patients with any serious TEAE11 (45.8)13 (65.0)
Patients with any treatment-related TEAE* (any grade)19 (79.2)14 (70.0)
Patients with any treatment-related TEAE of grade ≥34 (16.7)4 (20.0)
Patients with any serious treatment-related TEAE3 (12.5)3 (15.0)
Patients with any TEAE leading to definitive study drug discontinuation4 (16.7)3 (15.0)
Patients with any TEAE leading to premature discontinuation of isatuximab00
Patients with any TEAE leading to premature discontinuation of cemiplimab00
Patients with any AESI†10 (41.7)10 (50.0)
Patients with any AESI of grade ≥33 (12.5)3 (15.0)
  • *Treatment-related TEAEs are TEAEs related to at least one drug of the combination.

  • †AESIs include grade ≥2 IARs, grade ≥3 immune-related TEAEs, immune-related AEs of any grade in a patient previously treated with a PI3K inhibitor (only applicable for patients who receive cemiplimab), pregnancy, symptomatic overdose with IMP/NIMP.

  • AE, adverse event; AESI, adverse event of special interest; IAR, infusion-associated reaction; IMP, investigational medicinal product; mCRPC, metastatic castration-resistant prostate cancer; NIMP, non-investigational medicinal product; NSCLC, non-small cell lung cancer; TEAE, treatment-emergent adverse event.