Table 3.
Results of phase 3 HIMALAYA trial: safety outcome
| Event | STRIDE (n = 388) | Durvalumab (n = 388) | Sorafenib (n = 374) |
|---|---|---|---|
| TRAE, n (%) | 294 (75.8) | 202 (52.1) | 317 (84.8) |
| Grade 3/4 TRAE, n (%) | 100 (25.8) | 50 (12.9) | 138 (36.9) |
| Serious TRAE, n (%) | 68 (17.5) | 32 (8.2) | 35 (9.4) |
| TRAE leading to death, n (%) | 9 (2.3)a | 0 | 3 (0.8)b |
| TRAE leading to discontinuation, n (%) | 32 (8.2) | 16 (4.1) | 41 (11.0) |
| Grade 3/4 hepatic SMQ TRAE, n (%) | 23 (5.9) | 20 (5.2) | 17 (4.5) |
| Grade 3/4 hemorrhage SMQ TRAE, n (%) | 2 (0.5) | 0 | 4 (1.1) |
| Grade 3/4 immune-mediated TRAE, n (%) | 49 (12.6) | 24 (6.2) | 9 (2.4) |
| Immune-mediate AE requiring treatment with high-dose steroids, n (%) | 78 (20.1) | 37 (9.5) | 7 (1.9) |
| Immune-mediated AE leading to discontinuation of study treatment, n (%) | 22 (5.7) | 10 (2.6) | 6 (1.6) |
Modified from ref. [1]. SMQ, Standardized MedDRA Query; STRIDE, Single Tremelimumab Regular Interval Durvalumab; TRAE, treatment-related adverse event. a Nervous system disorder (n = 1), acute respiratory distress syndrome (n = 1), hepatitis (n = 1), myocarditis (n = 1), immune-mediated hepatitis (n = 2), pneumonitis (n = 1), hepatic failure (n = 1), myasthenia gravis (n = 1). b Hematuria (n = 1), cerebral hematoma (n = 1), hepatic failure (n = 1).