Presented by Prof Dr Lorenza Rimassa (IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy) & Prof Dr Jeroen Dekervel (University Hospitals Leuven, Belgium)
In this video, Prof Dr Jeroen Dekervel speaks with Prof Dr Lorenza Rimassa about the phase IIIB SIERRA study. The study evaluated STRIDE, consisting of a single tremelimumab plus regular-interval durvalumab, in patients with unresectable hepatocellular carcinoma (uHCC) and poor prognostic features that are typically excluded from registrational trials such as HIMALAYA.1 SIERRA enrolled 111 patients across three non-randomised cohorts defined by Child-Pugh B7/B8, ECOG performance status (PS) 2, or main portal vein thrombosis (Vp4), all treated with STRIDE. Co-primary endpoints were the incidence of grade 3 or 4 possibly related adverse events within 6 months of treatment initiation and objective response rate (ORR).
At a median follow-up of 10.1 months, grade 3 or 4 possibly related adverse events occurred in 19.8% of patients, lower than the 25-45% anticipated based on the HIMALAYA STRIDE arm. The overall response rate was 14.4%, with responses observed across all cohorts and the highest response rate in the ECOG PS 2 cohort (21.3%). Median overall survival was 10.6 months, and patients achieving disease control at 24 weeks had markedly longer survival than those without.
Prof Rimassa concludes that STRIDE demonstrated a manageable safety profile and meaningful efficacy in this higher-risk population, providing prospective evidence for its use in a broader range of patients with uHCC.
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