HIMALAYA (STRIDE regimen)
Trial question
Is tremelimumab plus durvalumab superior to sorafenib in patients with unresectable HCC?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
15.0% female
85.0% male
N = 782
782 patients (118 female, 664 male).
Inclusion criteria: patients with unresectable HCC and no previous systemic treatment.
Key exclusion criteria: hepatic encephalopathy within past 12 months; clinically meaningful ascites; main portal vein tumor thrombosis; active or prior documented gastrointestinal bleeding.
Interventions
N=393 STRIDE (300 mg tremelimumab for one dose plus 1,500 mg of durvalumab every 4 weeks).
N=389 sorafenib (at a dose of 400 mg BID).
Primary outcome
Median overall survival
16.43 months
13.77 months
16.4 months
12.3 months
8.2 months
4.1 months
0.0 months
STRIDE
Sorafenib
Significant
increase ▲
Significant increase in median overall survival (16.43 months vs. 13.77 months; HR 1.28, 96% CI 1.07 to 1.53).
Secondary outcomes
No significant difference in median progression-free survival (3.78 months vs. 4.07 months; HR 0.9, 95% CI 0.77 to 1.05).
Safety outcomes
No significant difference in adverse events and grade 3 or 4 adverse events.
Conclusion
In patients with unresectable HCC and no previous systemic treatment, STRIDE was superior to sorafenib with respect to median overall survival.
Reference
Ghassan K Abou-Alfa, George Lau, Masatoshi Kudo et al. Tremelimumab Plus Durvalumab in Unresectable Hepatocellular Carcinoma. NEJM Evid. 2022 Aug;1(8):EVIDoa2100070.
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