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 ≥3	13 (54.2)	12 (60.0)
Patients with any TEAE of grade 5	2 (8.3)	2 (10.0)
Patients with any serious TEAE	11 (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 ≥3	4 (16.7)	4 (20.0)
Patients with any serious treatment-related TEAE	3 (12.5)	3 (15.0)
Patients with any TEAE leading to definitive study drug discontinuation	4 (16.7)	3 (15.0)
Patients with any TEAE leading to premature discontinuation of isatuximab	0	0
Patients with any TEAE leading to premature discontinuation of cemiplimab	0	0
Patients with any AESI†	10 (41.7)	10 (50.0)
Patients with any AESI of grade ≥3	3 (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.