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ESMO GI 2025 | Real-world outcomes of durvalumab ± tremelimumab in uHCC

Ciro Celsa, MD, PhD, University of Palermo, Palermo, Italy, discusses results from the DT-REAL study of durvalumab with or without tremelimumab in unresectable hepatocellular carcinoma (uHCC) according to HIMALAYA (NCT03298451) eligibility criteria. Patients who met trial criteria experienced longer survival and improved outcomes compared with those outside the criteria, with response and disease control rates consistent with previous data. Safety findings showed manageable toxicity, with most adverse events low grade. 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 DT-REAL study is a multi-center study aiming to assess the safety and effectiveness of Durvalumab plus Tremelimumab for unresectable HCC. In this analysis we enrolled about 233 patients with unresectable HCC and we, across different centers in all the world, and we focused our analysis in comparing the outcomes according to key inclusion criteria of the HIMALAYA trial...

The DT-REAL study is a multi-center study aiming to assess the safety and effectiveness of Durvalumab plus Tremelimumab for unresectable HCC. In this analysis we enrolled about 233 patients with unresectable HCC and we, across different centers in all the world, and we focused our analysis in comparing the outcomes according to key inclusion criteria of the HIMALAYA trial. So we stratified the population in HIMALAYA in patients that are patients treated in first-line setting with Child-Pugh class with a performance status of 0 or 1 and without BCLC portal invasion versus HIMALAYA out patients. And basically we observed that patients classified as HIMALAYA in, so strictly fitting the main inclusion criteria of the HIMALAYA trial, displayed a significantly better outcome in terms especially of overall survival and also in terms of objective response rate. And from the point of view of the safety, both HIMALAYA in and HIMALAYA out patients show a good safety profile in absence of unexpected adverse events compared to the HIMALAYA trial results.

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