Table 3.
AEs reported with AZD8186 therapy (safety analysis set).
| Event, n (%) | AZD8186 monotherapy (dose finding) n = 63 | AZD8186 monotherapy (dose expansion) n = 20 | AZD8186 + AAP (dose finding) n = 16 | AZD8186 + AAP (dose expansion) n = 18 | AZD8186 + vistusertib n = 30 |
|---|---|---|---|---|---|
| Any AE | 63 (100.0) | 19 (95.0) | 16 (100) | 18 (100) | 29 (96.7) |
| Any AE causally related to AZD8186 only | 55 (87.3) | 11 (55.0) | 12 (75.0) | 15 (83.3) | 27 (90.0) |
| Any AE causally related to abiraterone acetate only | — | — | 10 (62.5) | 15 (83.3) | — |
| Any AE causally related to vistusertib only | — | — | — | — | 26 (86.7) |
| Any grade ≥3 AE | 39 (61.9) | 8 (40.0) | 9 (56.3) | 14 (77.8) | 23 (76.7) |
| Any grade ≥3 AE causally related to AZD8186 only | 20 (31.7) | 3 (15.0) | 5 (31.3) | 8 (44.4) | 17 (56.7) |
| Any grade ≥3 AE causally related to abiraterone acetate only | — | — | 4 (25.0) | 7 (38.9) | — |
| Any grade ≥3 AE causally related to vistusertib only | — | — | — | — | 17 (56.7) |
| Death | 0 | 0 | 1 (6.3) | 1 (5.6) | 2 (6.7) |
| Death causally related to AZD8186 only | 0 | 0 | 0 | 0 | 0 |
| Death causally related to abiraterone acetate only | — | — | 0 | 0 | — |
| Death causally related to vistusertib only | — | — | — | — | 0 |
| Any SAE (including deaths) | 23 (36.5) | 4 (20.0) | 9 (56.3) | 10 (55.6) | 15 (50.0) |
| Any SAE (including deaths), causally related to AZD8186 only | 10 (15.9) | 2 (10.0) | 3 (18.8) | 3 (16.7) | 11 (36.7) |
| Any SAE (including deaths), causally related to abiraterone acetate only | — | — | 0 | 3 (16.7) | — |
| Any SAE (including deaths), causally related to vistusertib only | — | — | — | — | 11 (36.7) |
| Any SAE causing discontinuation of AZD8186 | 6 (9.5) | 0 | 3 (18.8) | 2 (11.1) | 3 (10.0) |
| Any SAE causing discontinuation of AZD8186, causally related to AZD8186 only | 5 (7.9) | 0 | 2 (12.5) | 0 | 1 (3.3) |
| Any SAE causing discontinuation of AZD8186, causally related to abiraterone acetate only | — | — | 0 | 1 (5.6) | — |
| Any SAE causing discontinuation of AZD8186, causally related to vistusertib only | — | — | — | — | 1 (3.3) |
| Any AE leading to discontinuation of AZD8186 | 11 (17.5) | 1 (5.0) | 5 (31.3) | 4 (22.2) | 6 (20.0) |
| Any AE leading to discontinuation of abiraterone acetate | — | — | 3 (18.8) | 5 (27.8) | — |
| Any AE leading to discontinuation of vistusertib | — | — | — | — | 6 (20.0) |
| Any AE leading to dose modification of AZD8186 | 10 (15.9) | 0 | 2 (12.5) | 3 (16.7) | 5 (16.7) |
| Any AE leading to dose modification of abiraterone acetate | — | — | 2 (12.5) | 7 (38.9) | — |
| Any AE leading to dose modification of vistusertib | — | — | — | — | 4 (13.3) |
| Dose-limiting toxicities | 4 (7.7)a | — | 0b | — | 1 (5.0)c |
Abbreviations: AAP, abiraterone acetate plus prednisone; AE, adverse event; SAE, serious adverse event.
a n = 53 evaluable patients.
b14 evaluable patients.
c n = 20 evaluable patients