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. Author manuscript; available in PMC: 2023 May 15.
Published in final edited form as: Expert Rev Anticancer Ther. 2022 Sep 19;22(10):1017–1027. doi: 10.1080/14737140.2022.2124971

Table 2.

Summary of Adverse Events for Patients who received Tebentafusp on Clinical Trial

Trial Phase Any Grade
Adverse Events n
(%)		 Grade ≥3 Adverse Events n
(%)		 References
NCT01211262
N=84		 I/II Dermatologic Rash: 57 (68)
Pruritis: 59 (70)
Skin exfoliation: 24 (29)
Dry skin: 23 (27) Erythema: 19 (23)		 Rash: 22 (26)
Pruritis: 1(1)
Skin exfoliation: 0 (0)
Dry skin: 0 (0)
Erythema: 0 (0)		 [46]
Cytokine Release Syndrome CRS: 50 (60)
Other CRS-related: 8 (10)		 CRS: 0 (0)
Other CRS-related: 8 (10)
NCT02570308
N=42		 I Dermatologic Rash 13 (31)
Rash generalized: 9 (21.4)
Pruritis: 30 (71.4)
Skin exfoliation: 5 (11.9)
Dry skin: 27 (64.3)
Erythema: 17 (40.5)
Pigment Change: 18 (42.8)		 Rash 2 (4.8)
Rash generalized: 1 (2.4)
Pruritis: 2 (4.8)
Skin exfoliation: 0 (0)
Dry skin: 0 (0)
Erythema: 2 (4.8)
Pigment Change: 0 (0)		 [44]
Cytokine Release Syndrome CRS: 38 (90)
CRS requiring tocilizumab: 0 (0)
CRS requiring supplemental oxygen: 1 (2)		 CRS: 1 (2%)
Hepatic Toxicity AST increased: 8 (19)
Alkaline phosphatase increased: 8 (19)
Hepatic pain: 7 (16.7)
Hyperbilirubinemia: 6 (14.3)		 AST increased: 4 (9.5)
Alkaline phosphatase increased: 2 (4.8)
Hepatic pain: 0 (0)
Hyperbilirubinemia: 2 (4.8)
NCT02570308
N=127		 II Dermatologic Rash: 81 (64)
Pruritis: 85 (67)		 Rash: 16 (13) [51]
Cytokine Release Syndrome CRS: 109 (86) CRS: 5 (4)
Hepatic Toxicity Not reported AST increased: 6 (5)
NCT03070392
N=252		 III Dermatologic Rash: 203 (83)
Pruritis: 169 (69)
Dry skin: 72 (29)
Erythema: 56 (23)		 Rash: 45 (18)
Pruritis: 11 (4)
Dry skin: 0 (0)
Erythema: 0 (0)		 [53]
Cytokine Release Syndrome CRS: 217 (89) CRS: 2 (1)
Hepatic Toxicity AST increased: 47 (19)
ALT increased: 43 (18)
Hyperbilirubinemia: 21 (9)		 AST increased: 11 (4)
ALT increased: 7 (3)
Hyperbilirubinemia: 5 (2)