Table 2 Summary of exposure, overall safety summary and most common drug-related AEs (occurring in >2 patients in either study).
Study 1280.1 (weekly xentuzumab)a | Study 1280.2 (3-weekly xentuzumab)a | |||||
|---|---|---|---|---|---|---|
Patients, n (%) | Part I (n = 48) | Part II (n = 13) | Total (N = 61) | Part I (n = 33) | Part II (n = 31) | Total (N = 64) |
Exposure to xentuzumab treatment | ||||||
Treatment duration, days, median (range) | 43 (1–282) | 78 (1–498) | 57 (1–498) | 22 (1–232) | 36 (1–162) | 26 (1–232) |
Sum of treatment duration, years | 10.2 | 5.0 | 15.2 | 3.7 | 4.4 | 8.1 |
Number of infusions, median (range) | 6 (1–40) | 12 (1–71) | 9 (1–71) | 2 (1–11) | 6 (1–22) | N/A |
Overall AE summary | ||||||
Any AE | 46 (96) | 12 (92) | 58 (95) | 33 (100) | 31 (100) | 64 (100) |
Highest CTCAE grade AE | ||||||
Grade 3 | 10 (21) | 3 (23) | 13 (21) | 14 (42) | 9 (29) | 23 (36) |
Grade 4 | 4 (8) | 1 (8) | 5 (8) | 2 (6) | 1 (3) | 3 (5) |
Grade 5 | 3 (6) | 0 | 3 (5) | 0 | 0 | 0 |
DLTb | 1 (2) | 0 | 1 (2) | 0 | 0 | 0 |
Drug-related AE | 10 (21) | 2 (15) | 12 (20) | 14 (42) | 15 (48) | 29 (45) |
AE leading to discontinuation | 5 (10) | 0 | 5 (8) | 1 (3) | 2 (6) | 3 (5) |
AE leading to dose reduction | 0 | 0 | 0 | 0 | 0 | 0 |
Any SAE | 17 (35) | 4 (31) | 21 (34) | 9 (27) | 15 (48) | 24 (38) |
Drug-related AEs, n (%) | ||||||
Fatigue | 0 | 0 | 0 | 3 (9) | 4 (13) | 7 (11) |
Nausea | 1 (2) | 0 | 1 (2) | 4 (12) | 3 (10) | 7 (11) |
Lethargy | 0 | 0 | 0 | 5 (15) | 1 (3) | 6 (9) |
Decreased appetite | 0 | 0 | 0 | 3 (9) | 2 (6) | 5 (8) |
Diarrhoea | 0 | 0 | 0 | 2 (6) | 3 (10) | 5 (8) |
Constipation | 0 | 0 | 0 | 3 (9) | 0 | 3 (5) |
Infusion-related reaction | 0 | 0 | 0 | 0 | 3 (10) | 3 (5) |
Vomiting | 1 (2) | 1 (8) | 2 (3) | 0 | 1 (3) | 1 (2) |
Hyperglycaemia | 0 | 0 | 0 | 1 (3) | 1 (3) | 2 (3) |
Lymphocyte count decreased | 2 (4) | 0 | 2 (3) | 0 | 0 | 0 |
Platelet count decreased | 2 (4) | 0 | 2 (3) | 0 | 0 | 0 |
White blood cell count decreased | 2 (4) | 0 | 2 (3) | 0 | 0 | 0 |
Anaemia | 1 (2) | 1 (8) | 2 (3) | 0 | 0 | 0 |
Neutropenia | 0 | 0 | 0 | 0 | 2 (6) | 2 (3) |
Thrombocytopenia | 0 | 0 | 0 | 0 | 2 (6) | 2 (3) |
Oral candidiasis | 0 | 0 | 0 | 2 (6) | 0 | 2 (3) |
