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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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Advances in radiation therapy for HCC: Integration with liver-directed treatments
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“In addition, HIMALAYA trial showed that the combination of durvalumab, PD-L1 inhibitor, and treme-limumab, cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) inhibitor, also improved OS compared to sorafenib [12,13].”
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“Recently, immune checkpoint inhibitors (ICIs) have transformed the treatment landscape of advanced HCC, offering improved overall survival [8–10] and higher objective response (OR) rates [11–13].”
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“ICI/biologic (anti-VEGF) and ICI combination therapy in the IMbrave150 (atezolizumab and bevacizumab) and HIMALAYA (tremelimumab and durvalumab), respectively, yielded improved objective response rates (ORRs) and OS outcomes compared to sorafenib [5–8].”
Advances in Systemic Therapy for Hepatocellular Carcinoma and Future Prospects
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Treatment Patterns and Survival Outcomes Among Patients With Hepatocellular Carcinoma
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“In parallel, next-generation TKIs have shown substantial therapeutic potential by potently suppressing angiogenic and proliferative signaling cascades pertinent to HCC biology (5).”
Nivolumab plus ipilimumab for hepatocellular carcinoma: a game-changer?
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Foxp3+ Tregs in HCC immunity and immunotherapy
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GPC3-specific dnTGFβRII-armoured CAR T cells for hepatocellular carcinoma
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Strategies to enhance the response of liver cancer to pharmacological treatments
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“Afterward, the HIMALAYA trial with the combination of durvalumab and tremelimumab demonstrated a statistically significant improvement in the overall survival of patients with unresectable HCC [82].”
Cowzer, D., Chou, J. F., Walch, H. S., Keane, F., Khalil, D. N., Shia, J., Do, R. K. G., Yarmohammadi, H., Erinjeri, J. P., Dika, I. E., et al. (2024) · The Oncologist · doi:10.1093/oncolo/oyae110 · Cited by 5
“1,2,5,6 Consistent with the natural history of HCC, we also observed a higher burden of disease, more extrahepatic disease, higher AFP, and worse liver function in patients who received ICI in later treatment lines.”
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Structural insights into antibody-based immunotherapy for hepatocellular carcinoma
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THE CONCEPT OF “CONVERSE THERAPEUTIC HIERARCHY” FOR PATIENTS WITH HEPATOCELLULAR CARCINOMA
Vitale, A., Cabibbo, G., Rimassa, L., Iavarone, M. A., Colli, A., Crocetti, L., Pawlik, T. M., Gardini, A. C., Ponziani, F. R., Bargellini, I., et al. (2025) · Liver Cancer · doi:10.1159/000546360 · Cited by 5
“In addition, the recent advent of immune checkpoint inhibitors (ICIs) has drastically changed the landscape of HCC treatment [7], improving not only overall survival (OS) [8 – 10] but also objective response rates (ORR) [11 – 13].”
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Clinical value of identifying genes that inhibit hepatocellular carcinomas
Testa, U., Pelosi, E., & Castelli, G. (2022) · Expert Review of Molecular Diagnostics · doi:10.1080/14737159.2022.2154658 · Cited by 5
Trial watch: immunotherapeutic strategies on the horizon for hepatocellular carcinoma
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“…plus tremelimumab (STRID; single tremelimumab regular interval durvalumab) has recently been approved and made available for the treatment of unresectable advanced hepatocellular carcinoma as a new first-line treatment despite its use beyond second-line treatment not yet fully documented [3].”
BackgroundSequencing Systemic Therapy in Hepatocellular Carcinoma
Ponvilawan, B., & Roth, M. T. (2023) · Current Treatment Options in Oncology · doi:10.1007/s11864-023-01135-7 · Cited by 5
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“2,8 Considering the lack of uniformity, the limited proportion of patients with MPVT in the seminal studies, and the marked negative prognostic impact of MPVT on outcomes, the decision to exclude patients with MPVT from the trial-like cohort was taken by the investigators.”
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Treatment of Oligometastatic GI Cancers
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Immunotherapy as a Complement to Surgical Management of Hepatocellular Carcinoma
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“Second, the effectiveness of combination therapy with tremelimumab plus durvalumab has been proven in August 2022 (HIMALAYA) 19 .”
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Self-citationLaPelusa, M. B., Chamseddine, S., Cao, H. S. T., Xiao, L., Hasanov, E., Bhosale, P., Amin, H. M., Mohamed, Y. I., Yavuz, B. G., Sakr, Y., et al. (2024) · Oncology · doi:10.1159/000541250 · Cited by 6
“In the past 5 years, immunotherapy-based regimens have been shown to prolong overall survival in patients with advanced HCC compared to tyrosine kinase inhibitors, previously the therapy choice for this patient population [3, 4].”
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Up-front resection for hepatocellular carcinoma: Assessing futility in the preoperative setting
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“Furthermore, in 2022, the HIMALAYA trial showed that treatment with durvalumab (an anti‐PD‐L1 antibody) plus tremelimumab (an anti‐cytotoxic T‐lymphocyte‐associated antigen 4 antibody) (Dur/Tre) met its primary endpoint, demonstrating prolonged OS compared with sorafenib treatment [11].”
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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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