Avelumab (anti–PD-L1) as first-line switch-maintenance or second-line therapy in patients with advanced gastric or gastroesophageal junction cancer: phase 1b results from the JAVELIN Solid Tumor trial

Table 2 Any-grade TRAEs occurring in ≥10% of patients or grade ≥3 in any patient and infusion-related reactions in the first-line switch-maintenance or second-line subgroup

Patients, n (%)	1 L-mn subgroup (n = 90)				2 L subgroup (n = 60)
Patients, n (%)	Any grade	Grade 3	Grade 4	Grade 5	Any grade	Grade 3	Grade 4	Grade 5
Any TRAE^a	57 (63.3)	7 (7.8)	0	1 (1.1)	28 (46.7)	3 (5.0)	2 (3.3)	0
Fatigue	10 (11.1)	2 (2.2)	0	0	5 (8.3)	0	0	0
Decreased appetite	3 (3.3)	0	0	0	2 (3.3)	1 (1.7)	0	0
Asthenia	1 (1.1)	0	0	0	3 (5.0)	2 (3.3)	0	0
Colitis	2 (2.2)	1 (1.1)	0	0	0	0	0	0
Elevated amylase	2 (2.2)	0	0	0	1 (1.7)	1 (1.7)	0	0
Elevated lipase	2 (2.2)	1 (1.1)	0	0	1 (1.7)	0	1 (1.7)	0
Elevated γ-glutamyltransferase	2 (2.2)	1 (1.1)	0	0	0	0	0	0
Anemia	1 (1.1)	1 (1.1)	0	0	1 (1.7)	1 (1.7)	0	0
Decreased platelet count	1 (1.1)	1 (1.1)	0	0	1 (1.7)	0	1 (1.7)	0
Abdominal pain	1 (1.1)	1 (1.1)	0	0	0	0	0	0
Adrenal insufficiency	1 (1.1)	0	0	0	1 (1.7)	1 (1.7)	0	0
Autoimmune hepatitis^b	1 (1.1)	0	0	1 (1.1)	0	0	0	0
Decreased hemoglobin	1 (1.1)	1 (1.1)	0	0	0	0	0	0
Hepatic failure^b	1 (1.1)	0	0	1 (1.1)	0	0	0	0
Hyperglycemia	1 (1.1)	1 (1.1)	0	0	0	0	0	0
Hypokalemia	1 (1.1)	1 (1.1)	0	0	0	0	0	0
Peripheral motor neuropathy	1 (1.1)	1 (1.1)	0	0	0	0	0	0
Infusion-related reaction^c	20 (22.2)	1 (1.0)	0	0	11 (18.3)	0	0	0

^aThe incidence of treatment-related infusion-related reaction based on the single MedDRA preferred term is not listed
^bOccurred in the same patient
^cIncludes adverse events categorized as infusion-related reaction, drug hypersensitivity, or hypersensitivity reaction that occurred on the day of infusion or day after infusion, in addition to signs and symptoms of infusion-related reaction that occurred on the same day of infusion and resolved within 2 days (including adverse events classified by investigators as related or unrelated to treatment)
1 L-mn first-line switch-maintenance, 2 L second line, TRAE treatment-related adverse event