Table 1. Results of Phase 3 HIMALAYA trial: efficacy outcome.
| Efficacy outcome | HIMALAYA trial | ||
|---|---|---|---|
| STRIDE (D + T300) (n=393) | Durvalumab (n=389) | Sorafenib (n=389) | |
| Median follow-up, months | 33.2 | 32.6 | 32.2 |
| Median OS, months (95% CI) | 16.4 (14.2–19.6) | 16.6 (14.1–19.1) | 13.8 (12.3–16.1) |
| OS HR (96.02% CI) | 0.78 (0.65–0.93) | 0.86 (0.73–1.03) | |
| P value | 0.0035 | 0.0674 | |
| Median PFS, months (95% CI) | 3.8 (3.7–5.3) | 3.7 (3.2–3.8) | 4.1 (3.8–5.5) |
| PFS HR (95% CI) | 0.90 (0.77–1.05) | 1.02 (0.88–1.19) | |
| ORR, % | 20.1 | 17.0 | 5.1 |
| CR, n (%) | 12 (3.1) | 6 (1.5) | 0 |
| PR, n (%) | 67 (17.0) | 60 (15.4) | 20 (5.1) |
| SD, n (%) | 157 (39.9) | 147 (37.8) | 216 (55.5) |
| PD, n (%) | 157 (39.9) | 176 (45.2) | 153 (39.3) |
| DCR, n (%) | 236 (60.1) | 213 (54.8) | 236 (60.7) |
| Median DOR, months (IQR) | 22.34 (8.54–NR) | 16.82 (7.43–NR) | 18.43 (6.51–25.99) |
| Median TTR, months (95% CI) | 2.17 (1.84–3.98) | 2.09 (1.87–3.98) | 3.78 (1.89–8.44) |
| Remaining in response, months | |||
| 6 | 82.3 | 81.8 | 78.9 |
| 12 | 65.8 | 57.8 | 63.2 |
STRIDE, Single Tremelimumab Regular Interval Durvalumab; D + T300, durvalumab plus high dose tremelimumab; OS, overall survival; HR, hazard ratio; PFS, progression free survival; ORR, objective response rate; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; DCR, disease control rate; DOR, duration of response; NR, not reached; TTR, time to response.