Adjuvant Atezolizumab/Bevacizumab improves recurrence-free survival in patients with high-risk localized hepatocellular carcinoma: IMbrave050 trial
There are currently no proven or approved adjuvant therapy strategies for hepatocellular carcinoma (HCC). The patients who are treated with surgical resection or thermal ablation with curative intent tend to have significantly higher recurrence rates and shorter overall survival than patients with other types of cancer. IMbrave050 is a global phase III randomized controlled trial, which evaluated the efficacy of adjuvant atezolizumab and bevacizumab after complete surgical resection or ablation.
The trial enrolled patients with high-risk HCC with no evidence of extrahepatic disease or macrovascular invasion. The risk status was based on the size and number of tumors, the presence of lymphovascular invasion and tumor grade. The patients were randomized 1:1 to receive Atezolizumab with Bevacizumab every 21 days for 17 cycles vs active surveillance. At median follow-up of 17 months, the primary endpoint was met with a 28% reduction in risk of recurrence or death. The 12-month RFS was 78% in the study arm vs 65% in the control arm. The OS data was immature. The safety profile of adjuvant Atezo/Bev was generally consistent with that of the two agents with no new signals.
This is a landmark study and could be practice changing in the management of localized HCC and potentially improve the outcomes in these patients. The data is however not yet mature and we have to await the final results including the secondary endpoints such as overall survival.
References:
- Kudo, Masatoshi, et al. "Efficacy, safety and patient-reported outcomes (PROs) from the phase III IMbrave050 trial of adjuvant atezolizumab (atezo)+ bevacizumab (bev) vs active surveillance in patients with hepatocellular carcinoma (HCC) at high risk of disease recurrence following resection or ablation." (2023): 4002-4002.
- Chow, Pierce, et al. "Abstract CT003: IMbrave050: Phase 3 study of adjuvant atezolizumab+ bevacizumab versus active surveillance in patients with hepatocellular carcinoma (HCC) at high risk of disease recurrence following resection or ablation." Cancer Research 83.8_Supplement (2023): CT003-CT.
