HIMALAYA — Durvalumab With or Without Tremelimumab Versus Sorafenib in Unresectable Hepatocellular Carcinoma

Phase 3 · 2022 · Hepatocellular Carcinoma

Design

Randomized open-label trial of STRIDE (single 300 mg priming dose of tremelimumab + durvalumab every 4 weeks) vs durvalumab monotherapy vs sorafenib in first-line unresectable HCC.

Population

Adults with unresectable HCC, Child-Pugh A, ECOG 0-1, and no prior systemic therapy.

Primary Endpoint

overall survival (OS) for STRIDE versus sorafenib

Key Result

STRIDE mOS 16.4 vs 13.8 mo (HR 0.78); 3-yr OS 30.7% vs 20.2%; durvalumab monotherapy non-inferior to sorafenib (HR 0.86).

Guideline Impact

FDA-approved 2022; NCCN-listed first-line option for unresectable HCC, particularly when bevacizumab is contraindicated