Atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma
Open accessAbstract
BACKGROUND: The combination of atezolizumab and bevacizumab showed encouraging antitumor activity and safety in a phase 1b trial involving patients with unresectable hepatocellular carcinoma. METHODS: In a global, open-label, phase 3 trial, patients with unresectable hepatocellular carcinoma who had not previously received systemic treatment were randomly assigned in a 2:1 ratio to receive either atezolizumab plus bevacizumab or sorafenib until unacceptable toxic effects occurred or there was a loss of clinical benefit. The coprimary end points were overall survival and progression-free survival in the intention-to-treat population, as assessed at an independent review facility according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). RESULTS: The intention-to-treat population included 336 patients in the atezolizumab-bevacizumab group and 165 patients in the sorafenib group. At the time of the primary analysis (August 29, 2019), the hazard ratio for death with atezolizumab-bevacizumab as compared with sorafenib was 0.58 (95% confidence interval [CI], 0.42 to 0.79; P<0.001). Overall survival at 12 months was 67.2% (95% CI, 61.3 to 73.1) with atezolizumab-bevacizumab and 54.6% (95% CI, 45.2 to 64.0) with sorafenib. Median progression-free survival was 6.8 months (95% CI, 5.7 to 8.3) and 4.3 months (95% CI, 4.0 to 5.6) in the respective groups (hazard ratio for disease progression or death, 0.59; 95% CI, 0.47 to 0.76; P<0.001). Grade 3 or 4 adverse events occurred in 56.5% of 329 patients who received at least one dose of atezolizumab-bevacizumab and in 55.1% of 156 patients who received at least one dose of sorafenib. Grade 3 or 4 hypertension occurred in 15.2% of patients in the atezolizumab-bevacizumab group; however, other high-grade toxic effects were infrequent. CONCLUSIONS: In patients with unresectable hepatocellular carcinoma, atezolizumab combined with bevacizumab resulted in better overall and progression-free survival outcomes than sorafenib. (Funded by F. Hoffmann-La Roche/Genentech; ClinicalTrials.gov number, NCT03434379.).
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PD-L1 inhibitor-based regimens (atezolizumab plus bevacizumab and tremelimumab plus durvalumab) showed improved outcomes over sorafenib as first-line treatment for unresectable hepatocellular carcinoma, with median overall survival ranging from 16 months to 19 months.
“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 [9]
Split into 2 atoms — 0 confirmed, 1 partially supported, 1 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
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Experimental — accuracy not yet measuredWith PD-L1 inhibitors in this setting, median overall survival was 19.2 months with atezolizumab plus bevacizumab, 16.6 months with durvalumab monotherapy, and 16.4 months with tremelimumab plus durvalumab.
“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 [9]
The citation to this paper follows the atezolizumab–bevacizumab figure, so the durvalumab figures are not assessed here. In the Efficacy section (Figure 1A; page unavailable in our copy), median overall survival for atezolizumab–bevacizumab is listed as NE (not evaluable), not 19.2 months. The paper does report significantly longer overall survival than with sorafenib. (LLM, conf=0.88)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredEffective systemic therapies, especially immune-checkpoint inhibitors, have substantially improved outcomes for patients with advanced-stage hepatocellular carcinoma.
“Over the past two decades, the development of effective systemic therapies has substantially improved the outcomes of patients with advanced-stage HCC2–6.”
From Adjuvant and neoadjuvant immunotherapies in hepatocellular carcinoma (2024) · cites this paper as [4]
The Discussion reports significantly better overall and progression-free survival with atezolizumab plus bevacizumab than with sorafenib in previously untreated patients with advanced unresectable HCC. This supports improved outcomes from a systemic regimen containing a checkpoint inhibitor, but not the broader implication that checkpoint inhibitors generally produced substantial improvements over two decades: the paper says single-agent PD-1 inhibitors did not significantly improve overall survival in phase 3 studies. (LLM, conf=0.85)
Experimental — accuracy not yet measuredAtezolizumab plus bevacizumab, durvalumab plus tremelimumab, lenvatinib, and sorafenib are globally approved for first-line advanced HCC, but patients in the approval trials had not received prior adjuvant systemic therapy.
“At present, atezolizumab plus bevacizumab4, durvalumab plus tremelimumab148, lenvatinib149 and sorafenib3 are approved globally for the first-line treatment of advanced-stage HCC, although clearly no patients in the studies that led to these approvals received previous adjuvant systemic therapy1,2,6.”
From Adjuvant and neoadjuvant immunotherapies in hepatocellular carcinoma (2024) · cites this paper as [4]
The Patients section (p. not available) says participants in the atezolizumab–bevacizumab trial had not previously received systemic therapy for liver cancer, supporting the statement about prior adjuvant systemic therapy for this trial. The paper establishes that this combination was studied as first-line treatment, but our copy does not establish its global approval. The other regimens have separate citations in the citing sentence and are not attributed to this paper. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThe 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.
“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 [9]
The Efficacy section reports atezolizumab–bevacizumab response rates of 27.3% by RECIST 1.1 and 33.2% by mRECIST, broadly consistent with the claim’s approximately 30%. Our copy does not report a 20% response rate for durvalumab–tremelimumab or a median duration of response of 18–22 months; it reports the proportion of responses lasting more than six months instead (page unavailable). (LLM, conf=0.88)
Experimental — accuracy not yet measured
Combining two classes of immune checkpoint blockade or combining immune checkpoint blockade with VEGF inhibitors can improve overall survival in hepatocellular carcinoma.
“However, results from recent clinical trials suggest that combining two different classes of ICBs (e.g., anti–PD-1 and anti-CTLA4), or combining ICB with other modalities such as vascular endothelial growth factor (VEGF) inhibitors, can improve overall survival (4, 5).”
From Bile acid synthesis impedes tumor-specific T cell responses during liver cancer (2025) · cites this paper as [5]
ICI combinations can provide a higher tumor response rate and better survival.
“ICI combinations can provide a higher tumor response rate and better survival and may be a potential bias in this microbiota study.5 6”
From Gut microbiota and metabolites associate with outcomes of immune checkpoint inhibitor–treated unresectable hepatocellular carcinoma (2022) · cites this paper as [5]
Higher intra-tumoral genomic heterogeneity is a major driver for therapy resistance due to a larger plethora of potentially resistant clones.
“which is a major driver for therapy resistance due to a larger plethora of potentially resistant clones [61]”
From Etiology-Based Treatment for Unresectable/Advanced Hepatocellular Carcinoma: Focus on Viral Hepatitis and Metabolic Dysfunction-Associated Steatohepatitis (2025) · cites this paper as [61]
The Discussion reports treatment outcomes in unresectable hepatocellular carcinoma and says further biomarker analyses are needed to identify predictors of response. Our copy does not address whether intratumoral genomic heterogeneity produces resistant clones or drives therapy resistance (searched for genomic heterogeneity, resistant clones, and clonal resistance). (LLM, conf=0.76)
Experimental — accuracy not yet measuredBevacizumab plus atezolizumab is FDA-approved for unresectable or metastatic hepatocellular carcinoma in patients without prior systemic therapy.
“the use of bevacizumab (anti-angiogenic agent) in combination with atezolimumab (PD-L1 antibody) has been FDA approved for unresectable or metastatic hepatocellular carcinoma in patients who have not received prior systemic therapy”
From Hallmarks of response, resistance, and toxicity to immune checkpoint blockade (2021) · cites this paper as Finn et al., 2020
In 2020, the FDA approved atezolizumab combined with bevacizumab for advanced HCC based on IMbrave150.
“Then, in 2020, the FDA approved atezolizumab combined with bevacizumab for advanced HCC based on the data of IMbrave150 [111].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [111]
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Self-citationInflamed and non-inflamed classes of HCC: a revised immunogenomic classification
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Bile acid synthesis impedes tumor-specific T cell responses during liver cancer
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Epigenetics in hepatocellular carcinoma development and therapy: The tip of the iceberg
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“5-month improvement in progression-free survival as compared with sorafenib, although more than half of patients receiving the combination therapy suffered grade 3 or 4 adverse events (11).”
NASH and Hepatocellular Carcinoma: Immunology and Immunotherapy
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Repurposing of Benzimidazole Anthelmintic Drugs as Cancer Therapeutics
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RBM45 reprograms lipid metabolism promoting hepatocellular carcinoma via Rictor and ACSL1/ACSL4
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“As an example, the proportion of patients classified to have non-viral HCC ranged from less than 20% in CARES-310, 30.5% in IM-Brave150 to up to 45% in Checkmate-459 [27, 37, 62].”
Influential
- Authors
- Finn, R. S., Qin, S., Ikeda, M., Galle, P. R., Ducreux, M., Kim, T.-Y., Kudo, M., Breder, V., Merle, P., Kaseb, A. O., Li, D., Verret, W., Xu, D.-Z., Hernandez, S., Liu, J., Huang, C., Mulla, S., Wang, Y., Lim, H. Y., Zhu, A. X., & Cheng, A.-L.
- Affiliations
- City Of Hope National Medical Center (US)
- F. Hoffmann-La Roche AG (CH)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2020-05-14
- Volume
- 382
- Issue
- 20
- Pages
- 1894-1905
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3025022288
- Cited by
- 7,470
- References
- 28
- Citations by year
- 2026: 1069 · 2025: 1255 · 2024: 1288 · 2023: 1299 · 2022: 1227 · 2021: 1031 · 2020: 289 · 2019: 1 · 2016: 1 · 2014: 1
- FWCI
- 566.07
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Funders
- F. Hoffmann-La Roche
- Topics
- Health Sciences › Medicine › Hepatology › Hepatocellular Carcinoma Treatment and Prognosis
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Keywords
- atezolizumab, bevacizumab, hepatocellular carcinoma, unresectable liver cancer, sorafenib, immune checkpoint inhibitors, anti-VEGF therapy, combination therapy, overall survival, progression-free survival, hypertension, immune-related adverse events, first-line therapy, RECIST 1.1, anticancer activity
- MeSH terms
- Bevacizumab, Aged, Antineoplastic Combined Chemotherapy Protocols, Female, Carcinoma, Hepatocellular, Humans, Liver Neoplasms, Male, Middle Aged, Quality of Life, Survival Analysis, Kaplan-Meier Estimate, Intention to Treat Analysis, Programmed Cell Death 1 Receptor, Antibodies, Monoclonal, Humanized
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