Long-term Survival Observed in HIMALAYA Study of Durvalumab Plus Tremelimumab for uHCC

Four-year follow-up data from the HIMALAYA trial showed that single tremelimumab regular interval durvalumab (STRIDE) improved overall survival (OS) and demonstrated a durable long-term survival benefit in patients with unresectable hepatocellular carcinoma (uHCC). The study was presented at the Symposium on Clinical Interventional Oncology 2023.

In this analysis, 1171 patients were randomized to STRIDE (n=393), durvalumab (n=389), or sorafenib (n=389). OS and serious treatment-related adverse events (TRAEs) were the main study outcomes.

The estimated 36-month OS rates for STRIDE were 30.7% compared with 19.8% for sorafenib, which was consistent with the primary analysis. At 48 months, the OS rate remained higher for STRIDE (25.2%) versus sorafenib (15.1%), the researchers noted. They observed that TRAEs occurred in 17.5% of participants treated with STRIDE and 9.6% of participants treated with sorafenib, with no new events occurring after the primary analysis for STRIDE.

“These data reinforce the sustained, long-term OS benefit of STRIDE versus sorafenib in a diverse uHCC population, demonstrating unprecedented 3- and 4-year OS rates and [the] longest follow-up to date in phase 3 uHCC studies. STRIDE maintained a tolerable safety profile, with no new serious safety events,” the researchers concluded.