Table 2 Safety.
Event | AZD7648 (n = 14) | AZD7648 + PLD (n = 16) | ||
|---|---|---|---|---|
Any AE, n (%) | 12 (85.7) | 15 (93.8) | ||
Any grade 3/4 AE, n (%) | 8 (57.1) | 9 (56.3) | ||
Any SAE, n (%) | 5 (35.7) | 6 (37.5) | ||
Any DLT, n (%) | 1 (7.1) | 3 (18.8) | ||
Death, n (%) | 4 (28.6) | 1 (6.3) | ||
Any treatment-related AE, n (%) | ||||
Related to AZD7648 | 5 (35.7) | 15 (93.8) | ||
Related to PLD | – | 12 (75.0) | ||
Any treatment-related grade 3/4 AE, n (%) | ||||
Related to AZD7648 | 4 (28.6) | 8 (50.0) | ||
Related to PLD | – | 5 (31.3) | ||
Any treatment-related SAE, n (%) | ||||
Related to AZD7648 | 1 (7.1) | 3 (18.8) | ||
Related to PLD | – | 1 (6.3) | ||
Any AE leading to AZD7648 discontinuation, n (%) | 3 (21.4) | 3 (18.8) | ||
Any AE leading to PLD discontinuation, n (%) | – | 3 (18.8) | ||
Any AE leading to AZD7648 dose modification,* n (%) | 6 (42.9) | 10 (62.5) | ||
Any AE leading to PLD dose modification,* n (%) | – | 9 (56.3) | ||
TEAEs occurring in ≥20% of patients treated with either AZD7648 monotherapy or in combination with PLD† | Any grade | Grade ≥3 | Any grade | Grade ≥3 |
Anaemia | 4 (28.6) | 1 (7.1) | 11 (68.8) | 4 (25.0) |
Diarrhoea | 4 (28.6) | 1 (7.1) | 2 (12.5) | 0 |
Nausea | 4 (28.6) | 0 | 7 (43.8) | 0 |
Vomiting | 4 (28.6) | 0 | 1 (6.3) | 0 |
Decreased appetite | 3 (21.4) | 0 | 4 (25.0) | 0 |
Abdominal pain | 3 (21.4) | 0 | 1 (6.3) | 0 |
Fatigue | 3 (21.4) | 1 (7.1) | 8 (50.0) | 1 (6.3) |
Urinary tract infection | 2 (14.3) | 0 | 4 (25.0) | 0 |
Neutropenia | 2 (14.3) | 1 (7.1) | 5 (31.3) | 2 (12.5) |
Constipation | 1 (7.1) | 0 | 4 (25.0) | 0 |
Stomatitis | 1 (7.1) | 0 | 8 (50.0) | 2 (12.5) |
Neutrophil count decrease | NR | NR | 4 (25.0) | 4 (25.0) |
Platelet count decrease | NR | NR | 4 (25.0) | 1 (6.3) |
Infusion-related reaction | NR | NR | 4 (25.0) | 0 |
