6/28/23, 11:03 PM HIMALAYA (STRIDE) Pathway Feedback Search Clinical Topics Home Studies HIMALAYA STRIDE HIMALAYA STRIDE Disease Hepatocellular carcinoma 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 N = 782 85.0% male 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 16.4 months 13.77 https://web.pathway.md/studies/recWNect8xPyZMfmU 1/2 6/28/23, 11:03 PM HIMALAYA (STRIDE) Pathway 12.3 months 8.2 months 4.1 months Significant increase 0.0 months STRIDE Sorafenib 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, M.D., M.B.A. et al. Tremelimumab Plus Durvalumab in Unresectable Hepatocellular Carcinoma. NEJM Evid. 2022;1(8). Open reference URL https://web.pathway.md/studies/recWNect8xPyZMfmU 2/2