IMbrave050: trial | Bending the Curve: Trial by Trial

IMbrave050

Atezolizumab plus bevacizumab versus active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma (IMbrave050): a randomised, open-label, multicentre, phase 3 trial

Phase 3N = 668NCT04102098

Population

Adults with high-risk surgically resected or ablated HCC

Design

Global, open-label, randomised (1:1) phase 3 trial at 134 hospitals in 26 countries: atezolizumab 1200 mg plus bevacizumab 15 mg/kg intravenously every 3 weeks for 17 cycles (12 months) versus active surveillance; the primary end point was recurrence-free survival by independent review facility (IRF) assessment in the intention-to-treat population. Patients in the surveillance arm could cross over to atezolizumab plus bevacizumab after IRF-assessed recurrence (per the 2026 update).

Primary endpoint

RFS

Arms

Atezolizumab plus bevacizumab (experimental, n = 334): Atezolizumab 1200 mg plus bevacizumab 15 mg/kg intravenously every 3 weeks for 17 cycles (12 months)
Active surveillance (control, n = 334): Active surveillance

People

Qin S

RFSHR 0.72RFSHR 0.90 (95% CI 0.72–1.12)OSHR 1.26 (95% CI 0.85–1.87)

Show the numbers

Results reported for IMbrave050
Endpoint	Analysis	Atezolizumab plus bevacizumab	Active surveillance	Effect
RFSRecurrence-free survival by independent review facility assessment (primary end point)	interimmedian follow-up 17.4 monthsQin 2023	—	—	HR 0.72P=0.012Prespecified interim analysis. The paper gives the interval as an adjusted 95% CI of 0.53-0.98, so it is recorded here and not in the 95% CI field. Median RFS was not evaluable in either arm.
RFSHigh-risk HCC after curative-intent resection or ablation, as randomised (the abstract does not state the analysis population)Recurrence-free survival (IRF-assessed), updated post hoc analysis	long term-updateYopp 2026	—	—	HR 0.90 (95% CI 0.72–1.12)Updated post hoc analysis; the abstract does not give the length of follow-up. The authors state that the initial RFS benefit was not sustained.
OSHigh-risk HCC after curative-intent resection or ablation, as randomised (the abstract does not state the analysis population)Overall survival at the second interim analysis (secondary end point)	interimYopp 2026	—	—	HR 1.26 (95% CI 0.85–1.87)The abstract describes overall survival data as immature. Hazard ratio is for atezolizumab plus bevacizumab versus active surveillance.

Results reported for IMbrave050
Endpoint	Analysis	Atezolizumab plus bevacizumab	Active surveillance	Effect
RFSRecurrence-free survival by independent review facility assessment (primary end point)	interimmedian follow-up 17.4 monthsQin 2023	—	—	HR 0.72P=0.012Prespecified interim analysis. The paper gives the interval as an adjusted 95% CI of 0.53-0.98, so it is recorded here and not in the 95% CI field. Median RFS was not evaluable in either arm.
RFSHigh-risk HCC after curative-intent resection or ablation, as randomised (the abstract does not state the analysis population)Recurrence-free survival (IRF-assessed), updated post hoc analysis	long term-updateYopp 2026	—	—	HR 0.90 (95% CI 0.72–1.12)Updated post hoc analysis; the abstract does not give the length of follow-up. The authors state that the initial RFS benefit was not sustained.
OSHigh-risk HCC after curative-intent resection or ablation, as randomised (the abstract does not state the analysis population)Overall survival at the second interim analysis (secondary end point)	interimYopp 2026	—	—	HR 1.26 (95% CI 0.85–1.87)The abstract describes overall survival data as immature. Hazard ratio is for atezolizumab plus bevacizumab versus active surveillance.

Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.

Data table

Endpoint	HR	95% CI
RFS	0.9	0.72–1.12
OS	1.26	0.85–1.87

Appears in

2026 IMbrave050: early recurrence-free benefit not sustained on update

Sources

Qin S, Chen M, Cheng AL, Kaseb AO, Kudo M, Lee HC, et al. Atezolizumab plus bevacizumab versus active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma (IMbrave050): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023;402(10415):1835-1847.
PubMed DOI
Yopp A, Chen M, Cheng AL, Kaseb A, Kudo M, Lee HC, et al. Updated data from IMbrave050: Adjuvant atezolizumab plus bevacizumab for high-risk hepatocellular carcinoma. J Hepatol. 2026;84(6):1102-1111.
PubMed DOI