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IMbrave150

Atezolizumab plus bevacizumab versus sorafenib in patients with unresectable hepatocellular carcinoma who had not previously received systemic treatment

Phase 3N = 501NCT03434379

Population
Patients with unresectable hepatocellular carcinoma who had not previously received systemic treatment
Design
Global, open-label phase 3 trial; randomisation 2:1 to atezolizumab plus bevacizumab or sorafenib until unacceptable toxic effects or loss of clinical benefit. Co-primary end points were overall survival and progression-free survival in the intention-to-treat population, with progression assessed at an independent review facility under RECIST 1.1.
Primary endpoint
OS, PFS
Arms
  • Atezolizumab plus bevacizumab (experimental, n = 336): Atezolizumab 1,200 mg plus bevacizumab 15 mg/kg intravenously every 3 weeks
  • Sorafenib (control, n = 165): Sorafenib 400 mg orally twice daily
People
Finn RS, IMbrave150 Investigators
OSHR 0.58 (95% CI 0.42–0.79)Δ 12-month OS+12.6 pointsPFSHR 0.59 (95% CI 0.47–0.76)Δ median PFS+2.5 monthsOSHR 0.66 (95% CI 0.52–0.85)Δ median OS+5.8 months
Show the numbers
Results reported for IMbrave150
EndpointAnalysisAtezolizumab plus bevacizumabSorafenibEffect
OSprimaryFinn 202067.2% at 12 mo (61.3–73.1%)54.6% at 12 mo (45.2–64.0%)HR 0.58 (95% CI 0.42–0.79)P<0.001Primary analysis, data cut-off 29 August 2019. The abstract gives the hazard ratio and 12-month survival but no median overall survival.
PFSprimaryFinn 2020median 6.8 months (5.7–8.3)median 4.3 months (4.0–5.6)HR 0.59 (95% CI 0.47–0.76)P<0.001Progression assessed by independent review under RECIST 1.1.
OSlong term-updatemedian follow-up 15.6 monthsCheng 2022median 19.2 months (17.0–23.7)median 13.4 months (11.4–16.9)HR 0.66 (95% CI 0.52–0.85)P<0.001 (descriptive)Post hoc updated analysis, data cut-off 31 August 2020.
PFSlong term-updatemedian follow-up 15.6 monthsCheng 2022median 6.9 months (5.7–8.6)median 4.3 months (4.0–5.6)HR 0.65 (95% CI 0.53–0.81)P<0.001 (descriptive)Post hoc updated analysis, data cut-off 31 August 2020.
Results reported for IMbrave150
EndpointAnalysisAtezolizumab plus bevacizumabSorafenibEffect
OSprimaryFinn 202067.2% at 12 mo (61.3–73.1%)54.6% at 12 mo (45.2–64.0%)HR 0.58 (95% CI 0.42–0.79)P<0.001Primary analysis, data cut-off 29 August 2019. The abstract gives the hazard ratio and 12-month survival but no median overall survival.
PFSprimaryFinn 2020median 6.8 months (5.7–8.3)median 4.3 months (4.0–5.6)HR 0.59 (95% CI 0.47–0.76)P<0.001Progression assessed by independent review under RECIST 1.1.
OSlong term-updatemedian follow-up 15.6 monthsCheng 2022median 19.2 months (17.0–23.7)median 13.4 months (11.4–16.9)HR 0.66 (95% CI 0.52–0.85)P<0.001 (descriptive)Post hoc updated analysis, data cut-off 31 August 2020.
PFSlong term-updatemedian follow-up 15.6 monthsCheng 2022median 6.9 months (5.7–8.6)median 4.3 months (4.0–5.6)HR 0.65 (95% CI 0.53–0.81)P<0.001 (descriptive)Post hoc updated analysis, data cut-off 31 August 2020.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFSOSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.580.42–0.79
PFS0.590.47–0.76
OS0.660.52–0.85
PFS0.650.53–0.81
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Atezolizumab plus bevacizumab (experimental)
  • Sorafenib (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAtezolizumab plus bevacizumabSorafenib
0100.0%100.0%
466.5%52.5%
940.0%23.4%
1326.6%12.3%
1717.7%6.5%
Illustrative — modelled from reported values, not trial data. OS, long term-update.
0%25%50%75%100%010203040Months (modelled)
  • Atezolizumab plus bevacizumab (experimental)
  • Sorafenib (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsAtezolizumab plus bevacizumabSorafenib
0100.0%100.0%
1264.8%53.8%
2442.0%28.9%
3627.3%15.5%
4817.7%8.3%
Primary publication: Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, et al. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020;382(20):1894-1905. PubMedDOI

Appears in

Sources

  1. Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, et al. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020;382(20):1894-1905.

    PubMedDOI

  2. Cheng AL, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, et al. Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs. sorafenib for unresectable hepatocellular carcinoma. J Hepatol. 2022;76(4):862-873.

    PubMedDOI