Reviewing the SIERRA Trial of STRIDE in Poor-Prognosis HCC

James J. Harding, MD, presents the SIERRA study for Team Deep-Dish Pizza, reviewing the phase 3b, single-arm trial of the STRIDE regimen, tremelimumab plus durvalumab, in first-line unresectable hepatocellular carcinoma (HCC) with poor-prognosis features. Harding explains that SIERRA was designed to address populations excluded from HIMALAYA, enrolling patients with Child-Pugh class B7 or B8, ECOG performance status 2, or chronic main portal vein thrombosis (Vp4). He reviews the baseline characteristics of the 98-patient cohort, including a median age of 70, predominantly BCLC stage C disease, and a meaningful proportion with Child-Pugh class B. Harding presents the early safety analysis, noting that grade 3/4 event rates were generally consistent across subgroups and tracked with the original HIMALAYA population, while the Vp4 cohort showed higher rates of serious adverse events. He emphasizes that efficacy endpoints, including objective response, were immature at the data cutoff and should not be inferred from these safety data.