Table 3 Summary of Safety Results
Squamous | Non-squamous | |||||
|---|---|---|---|---|---|---|
Cohort 1 (n = 17) | Cohort 2 (n = 11) | Cohort 3 (n = 12) | Cohort 4 (n = 20) | Cohort 5 (n = 31) | ||
Treatment-related AEs, n (%) | 17 (100) | 11 (100) | 12 (100) | 18 (90.0) | 30 (96.8) | |
Grade ≥ 3 treatment-related AEs, n (%) | 3 (17.6) | 4 (36.4) | 2 (16.7) | 10 (50.0) | 11 (35.5) | |
Treated-related SAEs, n (%) | 4 (23.5) | 2 (18.2) | 2 (16.7) | 7 (35.0) | 11 (35.5) | |
Treatment-related AEs leading to dose interruption | 11 (64.7) | 7 (63.6) | 5 (41.7) | 15 (75.0) | 18 (58.1) | |
Treatment-related AEs leading to discontinuation of study treatment | 0 | 1 (9.1) | 0 | 4 (20.0) | 1 (3.2) | |
Treatment-related AEs leading to death | 0 | 0 | 0 | 0 | 2 (6.5) | |
Treatment-related AEs ≥ 20% in any group, n (%) | ||||||
Decreased appetite | 11 (64.7) | 7 (63.6) | 7 (58.3) | 14 (70.0) | 21 (67.7) | |
Anemia | 8 (47.1) | 7 (63.6) | 7 (58.3) | 14 (70.0) | 24 (77.4) | |
Infusion-related reactions | 11 (64.7) | 7 (63.6) | 7 (58.3) | 11 (55.0) | 12 (38.7) | |
Pruritus | 12 (70.6) | 8 (72.7) | 8 (66.7) | 7 (35.0) | 9 (29.0) | |
Rash | 11 (64.7) | 6 (54.5) | 5 (41.7) | 4 (20.0) | 8 (25.8) | |
Fatigue | 6 (35.3) | 6 (54.5) | 4 (33.3) | 9 (45.0) | 6 (19.4) | |
Hypoesthesia | 7 (41.2) | 10 (90.9) | 4 (33.3) | 3 (15.0) | 3 (9.7) | |
Constipation | 8 (47.1) | 2 (18.2) | 6 (50.0) | 7 (35.0) | 14 (45.2) | |
Nausea | 6 (35.3) | 1 (9.1) | 6 (50.0) | 4 (20.0) | 11 (35.5) | |
Arthralgia | 7 (41.2) | 5 (45.5) | 2 (16.7) | 2 (10.0) | 4 (12.9) | |
Amylase increased | 6 (35.3) | 5 (45.5) | 0 | 5 (25.0) | 10 (32.3) | |
Neutrophil count decreased | 2 (11.8) | 6 (54.5) | 1 (8.3) | 6 (30.0) | 9 (29.0) | |
White blood cell count decreased | 3 (17.6) | 5 (45.5) | 1 (8.3) | 6 (30.0) | 9 (29.0) | |
AST increased | 5 (29.4) | 2 (18.2) | 2 (16.7) | 4 (20.0) | 17 (54.8) | |
ALT increased | 3 (17.6) | 3 (27.3) | 4 (33.3) | 3 (15.0) | 13 (41.9) | |
Hypothyroidism | 5 (29.4) | 2 (18.2) | 1 (8.3) | 4 (20.0) | 11 (35.5) | |
Pyrexia | 3 (17.6) | 1 (9.1) | 2 (16.7) | 5 (25.0) | 4 (12.9) | |
Diarrhea | 4 (23.5) | 2 (18.2) | 2 (16.7) | 3 (15.0) | 6 (19.4) | |
Stomatitis | 2 (11.8) | 2 (18.2) | 3 (25.0) | 4 (20.0) | 4 (12.9) | |
Pain in extremity | 5 (29.4) | 2 (18.2) | 1 (8.3) | 2 (10.0) | 2 (6.5) | |
Hyperthyroidism | 2 (11.8) | 3 (27.3) | 1 (8.3) | 2 (10.0) | 5 (16.1) | |
Hypoproteinemia | 4 (23.5) | 1 (9.1) | 1 (8.3) | 2 (10.0) | 0 | |
Vomiting | 3 (17.6) | 2 (18.2) | 3 (25.0) | 0 | 9 (29.0) | |
Platelet count decreased | 2 (11.8) | 1 (9.1) | 1 (8.3) | 3 (15.0) | 10 (32.3) | |
Proteinuria | 0 | 0 | 1 (8.3) | 5 (25.0) | 11 (35.5) | |
Flushing | 1 (5.9) | 3 (27.3) | 2 (16.7) | 0 | 2 (6.5) | |
Peripheral edema | 1 (5.9) | 1 (9.1) | 3 (25.0) | 1 (5.0) | 4 (12.9) | |
Epistaxis | 1 (5.9) | 0 | 0 | 4 (20.0) | 6 (19.4) | |
Immune-related AEs, n (%) | 14 (82.4) | 7 (63.6) | 8 (66.7) | 13 (65.0) | 18 (58.1) | |
Immune-related AEs ≥ 10% in any group, n (%) | ||||||
Pruritus | 7 (41.2) | 6 (54.5) | 4 (33.3) | 6 (30.0) | 5 (16.1) | |
Rash | 5 (29.4) | 5 (45.5) | 3 (25.0) | 4 (20.0) | 4 (12.9) | |
Infusion-related reactions | 9 (52.9) | 5 (45.5) | 4 (33.3) | 2 (10.0) | 3 (9.7) | |
Amylase increased | 4 (23.5) | 5 (45.5) | 0 | 3 (15.0) | 3 (9.7) | |
Hypothyroidism | 5 (29.4) | 2 (18.2) | 0 | 4 (20.0) | 9 (29.0) | |
ALT increased | 3 (17.6) | 2 (18.2) | 3 (25.0) | 2 (10.0) | 7 (22.6) | |
AST increased | 4 (23.5) | 1 (9.1) | 2 (16.7) | 1 (5.0) | 8 (25.8) | |
Lipase increased | 3 (17.6) | 2 (18.2) | 1 (8.3) | 1 (5.0) | 3 (9.7) | |
Hyperthyroidism | 2 (11.8) | 3 (27.3) | 0 | 2 (10.0) | 5 (16.1) | |
Immune-mediated lung disease | 0 | 0 | 1 (8.3) | 2 (10.0) | 2 (6.5) | |
Grade ≥ 3 immune-related AEs, n (%) | ||||||
Lipase increased | 1 (5.9) | 1 (9.1) | 0 | 1 (5.0) | 0 | |
Rash | 0 | 1 (9.1) | 1 (8.3) | 0 | 0 | |
Immune-mediated myocarditis | 0 | 0 | 0 | 0 | 1 (3.2) | |
Hyperlipidemia | 0 | 1 (9.1) | 0 | 0 | 0 | |
