The HIMALAYA phase III study demonstrated that the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab) provides a sustained and clinically meaningful overall survival (OS) benefit compared to sorafenib for patients with previously untreated, unresectable hepatocellular carcinoma (uHCC).
The 5-year follow-up data established a new survival benchmark in uHCC, showing a 60-month (5-year) OS rate of 19.6% for STRIDE versus 9.4% for sorafenib. STRIDE’s survival curve showed a plateau starting around three years, suggesting a durable long-term benefit, while the regimen maintained a manageable safety profile with no new safety signals identified over the five years.
The study also highlighted that conventional response criteria (RECIST v1.1) may underestimate STRIDE’s benefit. Improved OS strongly correlated with any degree of tumor shrinkage and greater depth of response. The data suggest that focusing on ≥25% tumor shrinkage may be a more reliable predictor of clinical benefit and long-term survival with STRIDE than the conventional 30% cut-off required for a partial response. These results support STRIDE’s role as a global standard of care and provide novel insights for evaluating ICI-based treatments in uHCC.