Molecular Markers of Response to Anti-PD1 Therapy in Advanced Hepatocellular Carcinoma
Open accessAbstract
Background & aims Single-agent anti-PD1 checkpoint inhibitors convey outstanding clinical benefits in a small fraction (∼20%) of patients with advanced hepatocellular carcinoma (aHCC) but the molecular mechanisms determining response are unknown. To fill this gap, we herein analyze the molecular and immune traits of aHCC in patients treated with anti-PD1.Methods Overall, 111 tumor samples from patients with aHCC were obtained from 13 centers before systemic therapies. We performed molecular analysis and immune deconvolution using whole-genome expression data (n = 83), mutational analysis (n = 72), and histologic evaluation with an endpoint of objective response.Results Among 83 patients with transcriptomic data, 28 were treated in frontline, whereas 55 patients were treated after tyrosine kinase inhibitors (TKI) either in second or third line. Responders treated in frontline showed upregulated interferon-γ signaling and major histocompatibility complex II-related antigen presentation. We generated an 11-gene signature (IFNAP), capturing these molecular features, which predicts response and survival in patients treated with anti-PD1 in frontline. The signature was validated in a separate cohort of aHCC and >240 patients with other solid cancer types where it also predicted response and survival. Of note, the same signature was unable to predict response in archival tissue of patients treated with frontline TKIs, highlighting the need for fresh biopsies before immunotherapy.Conclusion Interferon signaling and major histocompatibility complex-related genes are key molecular features of HCCs responding to anti-PD1. A novel 11-gene signature predicts response in frontline aHCC, but not in patients pretreated with TKIs. These results must be confirmed in prospective studies and highlights the need for biopsies before immunotherapy to identify biomarkers of response.
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Patients with inflamed hepatocellular carcinomas tend to have a favourable prognosis and are the most likely to benefit from immune-checkpoint inhibitors.
“Overall, patients with inflamed HCCs tend to have a favourable prognosis and are the most likely to have improved outcomes when receiving ICIs owing to the presence of responsive immune cells72,78.”
From Adjuvant and neoadjuvant immunotherapies in hepatocellular carcinoma (2024) · cites this paper as [72]
The Results section, “Molecular Features of Patients With HCC Responding to Anti-PD1 in Front Line” (page unavailable), reports a higher objective-response rate for the Inflamed class than for the Intermediate and Excluded classes (7/9 versus 5/19). It does not establish a generally favourable prognosis for patients with inflamed HCC; the class’s progression-free-survival difference was a nonsignificant trend. The Discussion links immune-cell composition to response but does not establish that responsive cells cause the improved outcomes. (LLM, conf=0.87)
Experimental — accuracy not yet measuredPatients with non-inflamed hepatocellular carcinomas tend to have a low likelihood of benefiting from immunotherapies.
“Patients with HCCs classified as non-inflamed tend to have a low likelihood of benefiting from immunotherapies72,83.”
From Adjuvant and neoadjuvant immunotherapies in hepatocellular carcinoma (2024) · cites this paper as [72]
The Results section (‘Molecular Features of Patients With HCC Responding to Anti-PD1 in Front Line’; page unavailable) reports fewer objective responses in the non-inflamed Intermediate and Excluded classes than in the Inflamed class (5/19 versus 7/9). This supports a lower likelihood of response, but the study tested frontline anti-PD1 monotherapy, not immunotherapies generally. (LLM, conf=0.84)
Experimental — accuracy not yet measuredSeveral gene signatures capturing inflamed tumour microenvironment components are associated with favourable response to immune-checkpoint inhibitors, but none has been clinically validated.
“Several gene signatures capturing the inflamed components of the TME have been associated with a favourable response to ICIs69,72,78–81, but none has been clinically validated thus far.”
From Adjuvant and neoadjuvant immunotherapies in hepatocellular carcinoma (2024) · cites this paper as [72]
The Results section (‘Molecular Features of Patients With HCC Responding to Anti-PD1 in Front Line’; page unavailable) reports that several inflammatory gene signatures were enriched in HCC patients responding to first-line anti-PD1 therapy. The Discussion says the only FDA-approved anti-PD1 biomarkers are tumor mutational burden and microsatellite instability, and that the authors’ new signature still needs phase III evaluation. The paper therefore supports the association and the lack of established clinical use, but does not establish that no such signature has been clinically validated across all immune-checkpoint inhibitors and settings. (LLM, conf=0.82)
Experimental — accuracy not yet measured
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- Authors
- Haber, P. K., Castet, F., Torres-Martin, M., Andreu-Oller, C., Puigvehí, M., Miho, M., Radu, P., Dufour, J.-F., Verslype, C., Zimpel, C., Marquardt, J. U., Galle, P. R., Vogel, A., Bathon, M., Meyer, T., Labgaa, I., Digklia, A., Roberts, L. R., Mohamed Ali, M. A., Mínguez, B., Citterio, D., Mazzaferro, V., Finkelmeier, F., Trojan, J., Özdirik, B., Müller, T., Schmelzle, M., Bejjani, A., Sung, M. W., Schwartz, M. E., Finn, R. S., Thung, S., Villanueva, A., Sia, D., & Llovet, J. M.
- Affiliations
- Humboldt-Universität zu Berlin (DE)
- Hospital Clínic de Barcelona (ES)
- Tisch Cancer Institute (US)
- Universitat Autònoma de Barcelona (ES)
- University of Bern (CH)
- KU Leuven (BE)
- Johannes Gutenberg University Mainz (DE)
- University Medical Center of the Johannes Gutenberg University Mainz (DE)
- Medizinische Hochschule Hannover (DE)
- University College London (GB)
- Centre Hospitalier Universitaire Vaudois (CH)
- Mayo Clinic (US)
- University of Milan (IT)
- University Hospital Frankfurt (DE)
- Charité – Universitätsmedizin Berlin (DE)
- University of California, Los Angeles (US)
- Institució Catalana de Recerca i Estudis Avançats (ES)
- Corresponding author
- Llovet, Josep M.
- ORCID
- Haber, Philipp K.
- Castet, Florian
- Andreu-Oller, Carmen
- Puigvehí, Marc
- Radu, Pompilia
- Verslype, Chris
- Marquardt, Jens U.
- Galle, Peter R.
- Vogel, Arndt
- Bathon, Melanie
- Meyer, Tim
- Digklia, Antonia
- Roberts, Lewis R.
- Mínguez, Beatriz
- Citterio, Davide
- Mazzaferro, Vincenzo
- Finkelmeier, Fabian
- Trojan, Jörg
- Özdirik, Burcin
- Müller, Tobias
- Schmelzle, Moritz
- Bejjani, Anthony
- Sung, Max W.
- Schwartz, Myron E.
- Finn, Richard S.
- Thung, Swan
- Villanueva, Augusto
- Sia, Daniela
- Llovet, Josep M.
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2023-01
- Volume
- 164
- Issue
- 1
- Pages
- 72-88.e18
- ISSN
- 0016-5085 (ISSN-L)
- PMC
- PMC12182972
- OpenAlex
- W4295677793
- Cited by
- 145
- References
- 53
- Citations by year
- 2026: 24 · 2025: 38 · 2024: 38 · 2023: 37 · 2022: 7 · 2021: 1
- FWCI
- 13.07
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Gastroenterology (acceptedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Archivio Istituzionale della Ricerca (Universita Degli Studi Di Milano) (submittedVersion, other-oa)
- IRIS (submittedVersion)
- Lirias (submittedVersion)
- SERVAL (Université de Lausanne) (submittedVersion)
- Funders
- Bayer HealthCare Pharmaceuticals Inc
- Asociación Española para el Estudio del Hígado (MA 4443/2–2, SFB1292)
- Pharmaceuticals Bayer
- Fulbright Association
- Generalitat de Catalunya
- Agència de Gestió d'Ajuts Universitaris i de Recerca (SGR-1358)
- California Department of Fish and Game (HA 8754/1–1)
- Instituto de Salud Carlos III
- Albert Einstein Cancer Center (CLJUN20007CAST)
- Associazione Italiana per la Ricerca sul Cancro
- Deutsche Forschungsgemeinschaft
- National Institute of Diabetes and Digestive and Kidney Diseases (R01 DK128289)
- Volkswagen Foundation (SFB/TRR 209 - 314905040, Vo959/9–1)
- Mayo Clinic (P50 CA210964, SCHM2661/3–2)
- Samuel Waxman Cancer Research Foundation
- UCLH Biomedical Research Centre (C9380/A26813)
- Horizon 2020 Framework Programme
- Centro de Investigación Biomédica en Red de Cáncer
- Cancer Research UK
- U.S. Department of Defense (CA150272P3)
- European Commission
- National Cancer Institute (P30-CA196521)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Hepatology › Hepatocellular Carcinoma Treatment and Prognosis
- Health Sciences › Medicine › Epidemiology › Hepatitis B Virus Studies
- Keywords
- advanced hepatocellular carcinoma, anti-PD-1 therapy, immune checkpoint inhibitors, predictive biomarkers, interferon-gamma signaling, MHC class II antigen presentation, tumor immune microenvironment, immunotherapy response prediction
- MeSH terms
- Carcinoma, Hepatocellular, Humans, Liver Neoplasms, Prospective Studies, Biomarkers, Programmed Cell Death 1 Receptor
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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