HIMALAYA: tremelimumab plus durvalumab in unresectable hepatocellular carcinoma
A single priming dose of the CTLA-4 antibody tremelimumab followed by durvalumab lengthened survival compared with sorafenib in advanced liver cancer without the bleeding risk of bevacizumab, giving a second first-line immunotherapy standard.
Overview
Phase 3 trial of 1,171 patients with unresectable hepatocellular carcinoma and no prior systemic therapy randomised to STRIDE (single tremelimumab plus regular durvalumab), durvalumab alone or sorafenib.
Median overall survival was 16.4 months with STRIDE against 13.8 months with sorafenib (hazard ratio 0.78), with three-year survival of 30.7 versus 20.2 percent and durvalumab monotherapy non-inferior to sorafenib; grade 3 to 4 treatment-related adverse events were 25.8 versus 36.9 percent.
- Median overall survival 16.4 vs 13.8 months; hazard ratio 0.78.
- Three-year overall survival 30.7 percent vs 20.2 percent.
Durvalumab-tremelimumab is a first-line standard for advanced hepatocellular carcinoma, particularly for patients with varices or bleeding risk in whom atezolizumab-bevacizumab is unsuitable.
- Progression-free survival was not improved, reflecting a subset of long-term responders.
- Excluded main portal vein thrombosis.
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