6/28/23, 11:04 PM HIMALAYA (durvalumab) Pathway Feedback Search Clinical Topics Home Studies HIMALAYA (durvalumab) HIMALAYA (durvalumab) Disease Hepatocellular carcinoma Trial question Is durvalumab noninferior to sorafenib in patients with unresectable HCC? Study design Multi-center Open label RCT Population Characteristics of study participants 15.0% female N = 778 85.0% male 778 patients (118 female, 660 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=389 durvalumab (at a dose of 1,500 mg every 4 weeks) N=389 sorafenib (at a dose of 400 mg BID) Primary outcome Median overall survival 16.6 months 16.56 13.77 12.4 months https://web.pathway.md/studies/rechwCye3ATBS8fWP 1/2 6/28/23, 11:04 PM HIMALAYA (durvalumab) Pathway 8.3 months Difference not exceeding nonferiority margin 4.1 months 0.0 months Durvalumab Sorafenib Difference not exceeding nonferiority margin in median overall survival (16.56 months vs. 13.77 months; HR 0.86, 95% CI 0.73 to 1.03) Secondary outcomes No significant difference in median progression-free survival (3.65 months vs. 4.07 months; HR 1.02, 95% CI 0.88 to 1.19) 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, durvalumab was noninferior 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/rechwCye3ATBS8fWP 2/2