Reproducible safety and efficacy of durvalumab with or without tremelimumab for hepatocellular carcinoma in clinical practice: Results of the DT-real study
The DT-real study validates the efficacy and safety of STRIDE (durvalumab plus tremelimumab) in routine clinical practice, with HIMALAYA trial-eligible patients achieving 23-month median survival, and showing a safety profile comparable to that observed in the pivotal trial. Nearly half of real-world patients received treatment despite not meeting original trial criteria, reflecting urgent clinical need in this population with limited therapeutic options. As for other immunotherapy-based combinations, hepatic decompensation is a critical determinant of survival. Patients achieving disease control demonstrated substantially improved 24-month overall survival rates compared to those with progressive disease, confirming the findings of the exploratory analyses of the HIMALAYA trial.
Authors
- David James Pinato (ORCID: https://orcid.org/0000-0002-3529-0103)
- Rosanna Villani (ORCID: https://orcid.org/0000-0001-9875-019X)
- Haripriya Andanamala (ORCID: https://orcid.org/0009-0004-0298-512X)
- Shadi Chamseddine (ORCID: https://orcid.org/0000-0001-7715-0689)
- Melina Gonzalez
- Leonardo Stella (ORCID: https://orcid.org/0000-0002-3431-0803)
- Najib Ben Khaled (ORCID: https://orcid.org/0000-0002-9681-2542)
- Calogero Cammà (ORCID: https://orcid.org/0000-0002-9224-1914)
- Tiziana Pressiani (ORCID: https://orcid.org/0000-0001-6919-1536)
- Amit G. Singal (ORCID: https://orcid.org/0000-0002-1172-3971)
- Robin Kate Kelley (ORCID: https://orcid.org/0000-0002-1984-2430)
- Antonio D’Alessio (ORCID: https://orcid.org/0000-0002-9164-3671)
- Ciro Celsa (ORCID: https://orcid.org/0000-0002-5662-2162)
- Giuseppe Cabibbo (ORCID: https://orcid.org/0000-0002-0946-3859)
- Hidenori Toyoda (ORCID: https://orcid.org/0000-0002-1652-6168)
- Naoshi Nishida (ORCID: https://orcid.org/0000-0002-9111-5668)
- Masatoshi Kudo (ORCID: https://orcid.org/0000-0002-4102-3474)
- Caterina Vivaldi (ORCID: https://orcid.org/0000-0001-9307-2326)
- Angela Dalia Ricci (ORCID: https://orcid.org/0000-0002-0701-6764)
- Ilario Giovanni Rapposelli (ORCID: https://orcid.org/0000-0003-1802-5671)
- Pasquale Lombardi (ORCID: https://orcid.org/0000-0001-6262-2161)
- Susanna Varkey Ulahannan (ORCID: https://orcid.org/0000-0002-7234-2283)
- Ahmed Omar Kaseb (ORCID: https://orcid.org/0000-0002-9491-0587)
- Bernhard Scheiner (ORCID: https://orcid.org/0000-0002-4904-5133)
- Claudia Angela Maria Fulgenzi (ORCID: https://orcid.org/0000-0002-5654-9225)
- Alba Sparacino
- Ornella Carminati
- Matthias Pinter (ORCID: https://orcid.org/0000-0002-7260-532X)
- Marco Vaccaro
- Francesca Romana Ponziani (ORCID: https://orcid.org/0000-0002-5924-6238)
- Lorenza Rimassa (ORCID: https://orcid.org/0000-0001-9957-3615)
- Giulia Francesca Manfredi (ORCID: https://orcid.org/0000-0002-2399-5376)
- Elena Orlandi (ORCID: https://orcid.org/0000-0002-2559-7558)
- Bernardo Stefanini (ORCID: https://orcid.org/0000-0003-3800-5678)
- Gabriele Di Maria
- María Reig (ORCID: https://orcid.org/0000-0002-5711-9534)
- Ashwini Arvind (ORCID: https://orcid.org/0000-0003-1911-5396)
- Marta Fortuny (ORCID: https://orcid.org/0000-0003-4413-7909)
- Massimo Alberto Iavarone (ORCID: https://orcid.org/0000-0003-3493-6504)
- Andrea Casadei‐Gardini (ORCID: https://orcid.org/0000-0001-6289-7202)
- Michael Li (ORCID: https://orcid.org/0000-0003-0836-811X)
Institutions
- Università Cattolica del Sacro Cuore (IT)
- University of Foggia (IT)
- Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT)
- Humanitas University (IT)
- The University of Texas MD Anderson Cancer Center (US)
- Vita-Salute San Raffaele University (IT)
- University of Milan (IT)
- Hammersmith Hospital (GB)
- Agostino Gemelli University Polyclinic (IT)
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT)
- LMU Klinikum (DE)
- Ospedale Maggiore (IT)
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT)
- Azienda Unità Sanitaria Locale Piacenza (IT)
- Centro Clinico Nemo (IT)
- Hospital Clínic de Barcelona (ES)
- Ogaki Municipal Hospital (JP)
- Ospedale Infermi di Rimini (IT)
- Oklahoma State University Oklahoma City (US)
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (ES)
- Istituti di Ricovero e Cura a Carattere Scientifico (IT)
- Gastroenterology Hospital "Saverio de Bellis" (IT)
- Consorci Institut D'Investigacions Biomediques August Pi I Sunyer (ES)
- IRCCS Humanitas Research Hospital (IT)
- Azienda Ospedaliera Universitaria Pisana (IT)
- UCSF Helen Diller Family Comprehensive Cancer Center (US)
- Imperial College London (GB)
- University of Oklahoma Health Sciences Center (US)
- Universitat de Barcelona (ES)
- Medical University of Vienna (AT)
- Ludwig-Maximilians-Universität München (DE)
- The University of Texas Southwestern Medical Center (US)
- University of Palermo (IT)
- Kindai University (JP)
- University of Bologna (IT)
Publication Details
- Journal
- JHEP Reports
- Published
- 2025-11-21
- DOI
- https://doi.org/10.1016/j.jhepr.2025.101685
- Primary Topic
- Hepatocellular Carcinoma Treatment and Prognosis
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Eli Lilly and Company
- AstraZeneca
- Regeneron Pharmaceuticals
- Exelixis
- Agios Pharmaceuticals
- Incyte
- Compass Therapeutics
- Moderna
- Cancer Research UK
- National Institute for Health and Care Research
- European Commission
- Eisai
- European Society for Medical Oncology
- European Association for the Study of the Liver
- Servier
- Ipsen
- Cancer Treatment and Research Trust
- National Institutes of Health
- Genentech
- Chugai Pharmaceutical
- Imperial Experimental Cancer Medicine Centre
- Instituto de Salud Carlos III
- NIHR Imperial Biomedical Research Centre