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Although this article appeared in NEJM Evidence in 2022, it’s still being read by many oncologists in 2024. The HIMALAYA trial, a global phase 3 study, evaluated the efficacy and safety of tremelimumab plus durvalumab (STRIDE regimen) and durvalumab monotherapy compared to sorafenib in patients with unresectable hepatocellular carcinoma. The trial demonstrated significant improvements in overall survival with the STRIDE regimen and established durvalumab monotherapy as noninferior to sorafenib, potentially offering new treatment options for this patient population.
Key Points:
- The STRIDE regimen (single dose of tremelimumab plus durvalumab) significantly improved overall survival compared to sorafenib (median 16.43 vs 13.77 months; hazard ratio 0.78; P=0.0035).
- Durvalumab monotherapy was noninferior to sorafenib for overall survival (median 16.56 vs 13.77 months; hazard ratio 0.86).
- Objective response rates were higher with STRIDE (20.1%) and durvalumab (17.0%) compared to sorafenib (5.1%).
- Median time to deterioration of patient-reported global health status was longer for STRIDE (7.5 months) and durvalumab (7.4 months) compared to sorafenib (5.7 months).
- Grade 3/4 treatment-emergent adverse events occurred in 50.5% of patients with STRIDE, 37.1% with durvalumab, and 52.4% with sorafenib.
- The safety profiles of STRIDE and durvalumab were consistent with known profiles, with no new safety signals identified.
- The study excluded patients with thrombosis in the main trunk of the portal vein, which may limit generalizability to this subgroup.
HCN Medical Memo
The HIMALAYA trial results suggest that the STRIDE regimen and durvalumab monotherapy may offer new treatment options for patients with unresectable hepatocellular carcinoma, potentially improving overall survival and quality of life compared to sorafenib.
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