Table 2.
Safety summary (as-treated population)
| Incidence, n (%) | Durva | Durva + Ole | Durva + Mona | Durva + Danva |
|---|---|---|---|---|
| (n = 26) | (n = 21) | (n = 20) | (n = 16) | |
| Any TEAE | 18 (69.2) | 19 (90.5) | 15 (75.0) | 13 (81.3) |
| Grade ≥3 TEAEs | 5 (19.2) | 3 (14.3) | 2 (10.0) | 5 (31.3) |
| Serious TEAEs | 3 (11.5) | 2 (9.5) | 1 (5.0) | 5 (31.3) |
| Any TRAE | 9 (34.6) | 12 (57.1) | 10 (50.0) | 7 (43.8) |
| Grade ≥3 TRAEs | 0 | 1 (4.8) | 0 | 1 (6.3) |
| Serious TRAEsa | 1 (3.8) | 1 (4.8) | 0 | 1 (6.3) |
| AEs leading to treatment discontinuation | 0 | 1 (4.8) | 1 (5.0) | 1 (6.3) |
| Deathsb | 0 | 0 | 0 | 1 (6.3) |
Abbreviations: Danva, danvatirsen; Durva, durvalumab; Mona, monalizumab; Ole, oleclumab.
aSerious TRAEs included one patient with immune-mediated arthritis in the Durva arm; one patient with diabetic ketoacidosis in the Durva + Ole arm; and one patient with procedural hemorrhage in the Durva + Danva arm.
bDeath in the Durva + Danva arm was due to an AE of bronchial anastomosis complication, deemed not to be related to either study drug.