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    Liver and Bile

    J Hepatol. 2022;76(4):862–73

    Cheng AL, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Lim HY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Ma N, Nicholas A, Wang Y, Li L, Zhu AX, Finn RS

    Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab versus sorafenib for unresectable hepatocellular carcinoma


    Background and aims: IMbrave150 demonstrated that atezolizumab plus bevacizumab led to significantly improved overall survival (OS) and progression-free survival (PFS) compared with sorafenib in patients with unresectable hepatocellular carcinoma at the primary analysis (after a median 8.6 months of follow-up). Updated data were presented after 12 months of additional follow-up.
    Methods: Patients with systemic treatment-naive, unresectable hepatocellular carcinoma were randomized 2:1 to receive 1200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks or 400 mg sorafenib orally twice daily in this open-label, phase 3 study. Co-primary end points were OS and PFS by independently assessed RECIST 1.1 in the intention-to-treat population. Secondary efficacy end points included objective response rates and exploratory subgroup efficacy analyses. This is a post-hoc updated analysis of efficacy and safety.
    Results: From March 15, 2018, to January 30, 2019, 501 patients (intention-to-treat population) were randomly allocated to receive atezolizumab plus bevacizumab (n = 336) or sorafenib (n = 165). On August 31, 2020, after a median 15.6 (range, 0–28.6) months of follow-up, the median OS was 19.2 months (95% confidence interval [CI]: 17.0–23.7) with atezolizumab plus bevacizumab and 13.4 months (95% CI: 11.4–16.9) with sorafenib (hazard ratio [HR] = 0.66; 95% CI: 0.52–0.85; descriptive p < 0.001). The median PFS was 6.9 (95% CI: 5.7–8.6) and 4.3 (95% CI: 4.0–5.6) months in the respective treatment groups (HR = 0.65; 95% CI: 0.53–0.81; descriptive p < 0.001). Treatment-related grade 3/4 adverse events occurred in 143 (43%) of 329 and 72 (46%) of 156 safety-evaluable patients in the respective groups, and treatment-related grade 5 events occurred in 6 (2%) and 1 (< 1%) patients.

    Conclusion: After longer follow-up, atezolizumab plus bevacizumab maintained clinically meaningful survival benefits over sorafenib and had a safety profile consistent with the primary analysis.

    Prof. Dr. A.-L. Cheng, Department of Oncology, National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei, Taiwan,
    E-Mail: alcheng@ntu.edu.tw

    or

    R.S. Finn, M.D., Professor of Medicine, Division of Hematology and Oncology, Department of Medicine, Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles, CA, USA,
    E-Mail: rfinn@mednet.ucla.edu

    DOI: DOI: 10.1016/j.jhep.2021.11.030

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