Trial Design & Follow‑Up
HIMALAYA is a Phase III study in patients with unresectable HCC, comparing three arms: STRIDE: Single priming dose of tremelimumab plus regular-interval durvalumab Durvalumab monotherapy Sorafenib (control) The 5-year analysis, with data cut-off on March 1, 2024, included follow-up durations of approximately 62.5 months for STRIDE and 59.9 months for sorafenib.
Long-Term Survival Benefits
STRIDE vs. Sorafenib: Median Overall Survival (OS) benefit sustained: STRIDE reduced risk of death compared to sorafenib (HR 0.76, 95% CI 0.65–0.89). 5-year OS rates: 19.6% for STRIDE 9.4% for sorafenib Restricted mean survival over 5 years: 25.5 months with STRIDE 20.7 months with sorafenib Patients achieving disease control or any degree of tumor shrinkage had notably improved OS; for instance, those with >25% shrinkage had a 5-year survival rate of 50.7% with STRIDE vs 26.3% with sorafenib. Durvalumab monotherapy vs. Sorafenib: OS hazard ratio was 0.85 (95% CI 0.73–1.00), trending toward benefit, though less robust than STRIDE.
Safety & Long-Term Tolerability
No late-onset serious adverse events were observed with STRIDE over the extended follow-up period. Safety remained manageable in the long term.
Take‑Home Message
At the 5-year mark, the STRIDE regimen (tremelimumab + durvalumab) sustained a significant survival advantage over sorafenib in unresectable HCC, nearly doubling the 5-year survival rate, with a favorable and stable safety profile. Durvalumab monotherapy also showed positive trends, though less pronounced. These findings highlight STRIDE’s durable efficacy and reinforce its potential as a transformative first-line option in advanced HCC.