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Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma
Open accessAbstract
BACKGROUND: A single, high priming dose of tremelimumab (anti-cytotoxic T lymphocyte–associated antigen 4) plus durvalumab (anti–programmed cell death ligand-1), an infusion regimen termed STRIDE (Single Tremelimumab Regular Interval Durvalumab), showed encouraging clinical activity and safety in a phase 2 trial of unresectable hepatocellular carcinoma. METHODS: In this global, open-label, phase 3 trial, the majority of the patients we enrolled with unresectable hepatocellular carcinoma and no previous systemic treatment were randomly assigned to receive one of three regimens: tremelimumab (300 mg, one dose) plus durvalumab (1500 mg every 4 weeks; STRIDE), durvalumab (1500 mg every 4 weeks), or sorafenib (400 mg twice daily). The primary objective was overall survival for STRIDE versus sorafenib. Noninferiority for overall survival for durvalumab versus sorafenib was a secondary objective. RESULTS: In total, 1171 patients were randomly assigned to STRIDE (n=393), durvalumab (n=389), or sorafenib (n=389). The median overall survival was 16.43 months (95% confidence interval [CI], 14.16 to 19.58) with STRIDE, 16.56 months (95% CI, 14.06 to 19.12) with durvalumab, and 13.77 months (95% CI, 12.25 to 16.13) with sorafenib. Overall survival at 36 months was 30.7%, 24.7%, and 20.2%, respectively. The overall survival hazard ratio for STRIDE versus sorafenib was 0.78 (96.02% CI, 0.65 to 0.93; P=0.0035). Overall survival with durvalumab monotherapy was noninferior to sorafenib (hazard ratio, 0.86; 95.67% CI, 0.73 to 1.03; noninferiority margin, 1.08). Median progression-free survival was not significantly different among all three groups. Grade 3/4 treatment-emergent adverse events occurred for 50.5% of patients with STRIDE, 37.1% with durvalumab, and 52.4% with sorafenib. CONCLUSIONS: STRIDE significantly improved overall survival versus sorafenib. Durvalumab monotherapy was noninferior to sorafenib for patients with unresectable hepatocellular carcinoma. (Funded by AstraZeneca; ClinicalTrials.gov number, NCT03298451.)
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“The response rate was 20% with durvalumab plus tremelimumab and 30% with atezolizumab plus bevacizumab, with median duration of response ranging from 18 months to 22 months.”
From Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial (2025) · cites this paper as [7]
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“PD-L1 inhibitor-based regimens received approvals in 2020 (atezolizumab plus bevacizumab) and 2022 (tremelimumab plus durvalumab) as first-line treatment options for unresectable hepatocellular carcinoma after showing improved outcomes over sorafenib, with median overall survival ranging from 16 months to 19 months.”
From Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial (2025) · cites this paper as [7]
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“With the introduction of PD-L1 inhibitors in this setting, survival benefits versus sorafenib were improved with a median overall survival of 19•2 months with atezolizumab plus bevacizumab, 9,10 16•6 months with durvalumab monotherapy, and 16•4 months with tremelimumab plus durvalumab, 7,8 leading to regulatory”
From Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial (2025) · cites this paper as [7]
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“At the RP2D, the safety profile was consistent with the known safety profile of durvalumab in combination with tremelimumab in adult patients (13, 14), and no new safety signals were identified in our pediatric population.”
From Phase I/II, open-label, multicenter study of durvalumab in combination with tremelimumab in pediatric patients with advanced solid tumors (2026) · cites this paper as [14]
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“durvalumab plus tremelimumab has demonstrated improved OS compared with sorafenib alone in adults with unresectable hepatocellular cancer (14).”
From Phase I/II, open-label, multicenter study of durvalumab in combination with tremelimumab in pediatric patients with advanced solid tumors (2026) · cites this paper as [14]
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“In HIMALAYA, durvalumab plus tremelimumab yielded an objective response rate of 20% and median duration of response of 22•3 months.7”
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“up to 20% of OBIs may be negative for both HBsAg and hepatitis B core antibody (anti-HBc) with existing assays [67, 68]”
From Etiology-Based Treatment for Unresectable/Advanced Hepatocellular Carcinoma: Focus on Viral Hepatitis and Metabolic Dysfunction-Associated Steatohepatitis (2025) · cites this paper as [68]
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Citations
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Liver Transplantation for Hepatocellular Carcinoma: A Narrative Review and A Glimpse into The Future
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“Based on the phase 3 IMBrave 150 [3] and HIMALAYA [4] studies, immune checkpoint inhibitor (ICI)-based combination regimens are now the standard first-line treatment for patients with unresectable HCC. Recently, rivoceranib, a VEGFR2-targeted multikinase inhibitor (MKI), combined with camrelizumab,…”
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Systemic Chemotherapy for Advanced Hepatocellular Carcinoma in Patients With Child-Pugh class B
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“These treatments have demonstrated significant improvements in overall survival rates [17,23,24].”
BackgroundMethodApproach to immunotherapy for HCC in the liver transplant population
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“[2] In the HIMALAYA trial, a single infusion of tremelimumab followed by regular intervals of durvalumab infusions led to a median overall survival of 16.4 months versus 13.8 months with only sorafenib.”
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“When combined with either antiangiogenic therapy or anti-cytotoxic T lymphocyte antigen-4 antibody, PD-1 blockade provides greater survival benefits than sorafenib provides [4 – 6].”
InfluentialSelf-citationSurgical approach to hepatocellular carcinoma: a review
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Current Trends in Hepatocellular Carcinoma Therapies in China
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“These developments underscore both the progress made and the lingering debates within the field, emphasizing the necessity for ongoing research to optimize and personalize treatment strategies for HCC [10, 12].”
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“Recently, various molecular targeted agents (MTAs) and immune checkpoint inhibitors (ICIs) have shown promising re-sults [5–8].”
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Immunotherapy in liver transplantation for hepatocellular carcinoma: A comprehensive review
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“Additionally, durvalumab (Dur) plus trem-elimumab (Tre) (Dur/Tre) has recently been introduced as initial combination immunotherapy, based on HI-MALAYA trial results presented in 2023 [12].”
Self-citationUSP24 promotes hepatocellular carcinoma progression by deubiquitinating and stabilizing YAP1
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“Additionally, the STRIDE regimen (single tremelimumab priming dose with durvalumab), validated in the phase III HIMALAYA trial (median OS: 16.4 months), has been approved as an alternative first-line option [8].”
InfluentialSBRT for bridging and downstaging HCC before transplant
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A history of the treatment of primary liver cancer
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“For example, HBV DNA was tested in all patients in HIMALAYA, and HBV infection was defined by positive HBsAg, detectable HBV DNA or anti-HBc [69].”
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A Post-International Gastrointestinal Cancers’ Conference (IGICC) Position Statements
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“107 The potential effectiveness of lenvatinib, as indicated by the REFLECT study (80), led to an investigation of a combination therapy consisting of lenvatinib and pembrolizumab.”
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“Currently, atezolizumab/bevacizumab (Atezo/Bev) and durvalumab/tremelimumab are considered the first-line combination therapy for the treatment of unresectable, advanced HCC with the former regimen resulting in objective response in up to one-third of these patients [5, 7–9].”
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“39 The strengths of this study are the high-quality data and consistent follow-up from a prospective clinical trial, and specifically the blinded independent assessment of tumor response.”
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Immune-checkpoint inhibitor resistance in patients with cancer
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“38 In contrast, the HIMALAYA 39 and CheckMate 459 studies 40 trials found that patients with AFP ≥400 ng/mL had improved survival following treatment with tremelimumab plus durvalumab and nivolumab, respectively.”
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“Atezolizumab plus bevacizumab, as well as the “STRIDE” regimen, have replaced sorafenib as the preferred first-line options; lenvatinib has also shown comparable survival benefits [2–5].”
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“The HIMALAYA trial was designed to compare the combination of durvalumab and tremelimumab (Dur/Tre), a PD‐L1 inhibitor plus an anti‐ cytotoxic T‐lymphocyte–associated antigen 4 agent, to sorafenib, demonstrating significant extension of OS in patients receiving Dur/Tre [6].”
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Pioneering precision: The evolution of immunotherapy for hepatocellular carcinoma
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Self-citationAkkermansia muciniphila and HCC: A Gut Feeling
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Hepatocellular carcinoma and liver transplant: What about neo- and adjuvant immunotherapy
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Regulated necrosis at the crossroads of liver inflammation and cancer development
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Immunologic effects of locoregional therapies for unresectable hepatocellular carcinoma
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“10,11 However, the response to ICIs in HCC is inferior to that of other cancer entities and varies among patients, and therapy-limiting adverse events occur frequently, calling for further strategies to improve tumor susceptibility.”
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Recent advancements in radiotherapy for hepatocellular carcinoma
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“65,68,69 Although multiple locoregional therapies are available for the treatment of HCC, none of them are unsuitable for patients with major PVTT. 88-90 These encouraging results prompted exploration of radiotherapy in combination with immunotherapy.”
Self-citation
Metadata
- Authors
- Abou-Alfa, G. K., Lau, G., Kudo, M., Chan, S. L., Kelley, R. K., Furuse, J., Sukeepaisarnjaroen, W., Kang, Y.-K., Van Dao, T., De Toni, E. N., Rimassa, L., Breder, V., Vasilyev, A., Heurgué, A., Tam, V. C., Mody, K., Thungappa, S. C., Ostapenko, Y., Yau, T., Azevedo, S., Varela, M., Cheng, A.-L., Qin, S., Galle, P. R., Ali, S., Marcovitz, M., Makowsky, M., He, P., Kurland, J. F., Negro, A., & Sangro, B.
- Affiliations
- Department of Medicine, Memorial Sloan Kettering Cancer Center, New York
- Humanity & Health (CN)
- Kindai University Hospital (JP)
- Chinese University of Hong Kong (HK)
- University of California, San Francisco (US)
- Kyorin University (JP)
- Khon Kaen University (TH)
- Asan Medical Center (KR)
- Cancer Research and Clinical Trials Center, Department of Optimal Therapy, National Cancer Hospital, Hanoi, Vietnam
- Department of Medicine II, University Hospital, Ludwig Maximilian University Munich, Munich, Germany
- Humanitas University (IT)
- Russian Cancer Research Center NN Blokhin (RU)
- Department of Oncology, Railway Clinical Hospital, St. Petersburg, Russia
- Department of Hepato-Gastroenterology, Robert-Debré Hospital, Reims, France
- University of Calgary (CA)
- Mayo Clinic (US)
- Sri Venkateshwara Hospital, Bangalore, India
- National Cancer Institute (UA)
- Queen Mary Hospital (CN)
- Unidade de Pesquisa em Oncologia Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil
- Liver Unit, Hospital Universitario Central de Asturias, Universidad de Oviedo, Instituto Universitario de Oncología del Principado de Asturias–Obra Social Cajastur, Instituto de Investigación Sanitaria del Principado de Asturias, Fundación para la Investigación y la Innovación Biosanitaria del Principado de Asturia, Oviedo, Spain
- National Taiwan University (TW)
- 81th Hospital of PLA (CN)
- University Medical Center of the Johannes Gutenberg University Mainz (DE)
- AstraZeneca (United States) (US)
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (ES)
- ORCID
- Lau, George
- Kudo, Masatoshi
- Chan, Stephen L.
- Kelley, Robin Kate
- Furuse, Junji
- Sukeepaisarnjaroen, Wattana
- Kang, Yoon-Koo
- Rimassa, Lorenza
- Breder, Valeriy
- Heurgué, Alexandra
- Tam, Vincent C.
- Mody, Kabir
- Yau, Thomas
- Cheng, Ann-Lii
- Qin, Shukui
- Galle, Peter R.
- Marcovitz, Michelle
- He, Philip
- Kurland, John F.
- Negro, Alejandra
- Sangro, Bruno
- Venue
- NEJM Evidence
- Publisher
- Massachusetts Medical Society
- Published
- 2022-07-26
- Volume
- 1
- Issue
- 8
- Pages
- EVIDoa2100070-EVIDoa2100070
- ISSN
- 2766-5526 (ISSN-L)
- OpenAlex
- W4281645619
- Cited by
- 1,576
- References
- 23
- Citations by year
- 2026: 356 · 2025: 450 · 2024: 421 · 2023: 284 · 2022: 63
- FWCI
- 181.48
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- NEJM Evidence (publishedVersion)
- PubMed (publishedVersion)
- Funders
- AstraZeneca
- Topics
- Health Sciences › Medicine › Hepatology › Hepatocellular Carcinoma Treatment and Prognosis
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Epidemiology › Hepatitis B Virus Studies
- Keywords
- tremelimumab, durvalumab, hepatocellular carcinoma, unresectable liver cancer, CTLA-4 blockade, PD-L1 blockade, sorafenib, overall survival, non-inferiority, immune checkpoint inhibitors, combination immunotherapy, progression-free survival, treatment-emergent adverse events, immune-related adverse events, non-small cell lung cancer
- MeSH terms
- Antineoplastic Agents, Immunological, Sorafenib, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Female, Carcinoma, Hepatocellular, Humans, Liver Neoplasms, Male, Middle Aged, Antibodies, Monoclonal, Humanized
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