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ESMO GI 2025 | SIERRA: safety results of the STRIDE regimen in advanced HCC
Stephen Lam Chan, MD, FRCP, Chinese University of Hong Kong, Hong Kong, China, discusses the Phase IIIb SIERRA study (NCT05883644) of durvalumab and tremelimumab (STRIDE regimen) as first-line treatment in patients with advanced hepatocellular carcinoma (HCC) with poor prognosis features. These included impaired liver function, reduced performance status, or extensive vascular invasion. Despite the high-risk population, the safety profile remained consistent with prior data, with manageable adverse events and low treatment-related discontinuation or mortality rates. This interview took place at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancer 2025 Congress in Barcelona, Spain.
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Transcript
The SIERRA study is a Phase IIIb single-arm study looking at the first-line use of the strike regimen in the HCC patient with adverse prognostic features, including those patients with Child-Pugh B function or ECOG performance status 2 or patients with main portal vein thrombosis, i.e., the Vp4. There are two co-primary endpoints. One is the adverse events possibly related to study treatment, grade 3 to 4, within six months of time...
The SIERRA study is a Phase IIIb single-arm study looking at the first-line use of the strike regimen in the HCC patient with adverse prognostic features, including those patients with Child-Pugh B function or ECOG performance status 2 or patients with main portal vein thrombosis, i.e., the Vp4. There are two co-primary endpoints. One is the adverse events possibly related to study treatment, grade 3 to 4, within six months of time. Another co-primary endpoint is the overall response rate. So in the ESMO GI 2025, we presented the AE endpoint. In summary, those patients who developed the AE possibly related to the treatment within six months, grade 2 to grade 4, it occurred in around 19% of the patients. But a small number of patients stopped the treatment because of this AE and only two patients died from the AE in this study. And this is considered safe and manageable in this group of patients with adverse prognostic factors. So I think this provides very important data that for these patients who are sicker, who are not usually recruited in a clinical trial, they may also be safe to be treated with a strike regimen.
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