Table 3

Safety summary

Group 3
cemiplimab
350 mg intravenously Q3W (n=56)
Group 1
cemiplimab
3 mg/kg intravenously Q2W (n=59)
Total
(Groups 1+3)
(n=115)
Any gradeGrade ≥3Any gradeGrade ≥3Any gradeGrade ≥3
Any TEAE, regardless of attribution54 (96.4)22 (39.3)59 (100.0)30 (50.8)113 (98.3)52 (45.2)
TEAEs, regardless of attribution, that led to discontinuation3 (5.4)2 (3.6)6 (10.2)4 (6.8)9 (7.8)6 (5.2)
Most common TEAEs*, regardless of attribution
Fatigue16 (28.6)3 (5.4)15 (25.4)1 (1.7)31 (27.0)4 (3.5)
Diarrhea10 (17.9)0 (0.0)17 (28.8)1 (1.7)27 (23.5)1 (0.9)
Nausea10 (17.9)0 (0.0)14 (23.7)0 (0.0)24 (20.9)0 (0.0)
Rash9 (16.1)0 (0.0)10 (16.9)0 (0.0)19 (16.5)0 (0.0)
Constipation7 (12.5)0 (0.0)10 (16.9)1 (1.7)17 (14.8)1 (0.9)
Pruritus6 (10.7)0 (0.0)10 (16.9)0 (0.0)16 (13.9)0 (0.0)
Maculopapular rash7 (12.5)1 (1.8)8 (13.6)0 (0.0)15 (13.0)1 (0.9)
Anemia7 (12.5)5 (8.9)7 (11.9)2 (3.4)14 (12.2)7 (6.1)
Arthralgia5 (8.9)0 (0.0)9 (15.3)0 (0.0)14 (12.2)0 (0.0)
Cough4 (7.1)0 (0.0)9 (15.3)0 (0.0)13 (11.3)0 (0.0)
Headache2 (3.6)0 (0.0)11 (18.6)0 (0.0)13 (11.3)0 (0.0)
Decreased appetite4 (7.1)0 (0.0)8 (13.6)0 (0.0)12 (10.4)0 (0.0)
Hypothyroidism6 (10.7)0 (0.0)6 (10.2)0 (0.0)12 (10.4)0 (0.0)
Vomiting6 (10.7)0 (0.0)6 (10.2)0 (0.0)12 (10.4)0 (0.0)
Peripheral edema6 (10.7)0 (0.0)4 (6.8)0 (0.0)10 (8.7)0 (0.0)
Upper respiratory tract infection3 (5.4)0 (0.0)6 (10.2)0 (0.0)9 (7.8)0 (0.0)
Dizziness1 (1.8)0 (0.0)7 (11.9)0 (0.0)8 (7.0)0 (0.0)
Dry skin2 (3.6)0 (0.0)6 (10.2)0 (0.0)8 (7.0)0 (0.0)
Pneumonitis2 (3.6)0 (0.0)6 (10.2)3 (5.1)8 (7.0)3 (2.6)
Dyspnea1 (1.8)0 (0.0)6 (10.2)2 (3.4)7 (6.1)2 (1.7)
Oropharyngeal pain0 (0.0)0 (0.0)6 (10.2)0 (0.0)6 (5.2)0 (0.0)
Treatment-related 36 (64.3)7 (12.5)46 (78.0)9 (15.3)82 (71.3)16 (13.9)
  • Data are number of patients (%).

  • *Adverse events reported in ≥10% of patients in either treatment group are presented, ordered by frequency in both groups combined.

  • †See online supplement for additional details on treatment-related adverse events.

  • Q2W, every 2 weeks; Q3W, every 3 weeks; TEAEs, treatment-emergent adverse events.