Posted: Monday, November 20, 2023
According to Pierce K.H. Chow, MD, of the National Cancer Centre, Singapore, and colleagues, treatment with the anti–PD-L1 antibody atezolizumab plus the VEGF-targeting monoclonal antibody bevacizumab improved recurrence-free survival compared with active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma. The results of the multicenter phase III IMbrave050 trial, which were published in The Lancet, also showed a safety profile consistent with previous reports for this adjuvant treatment option.
Between December 2019 and November 2021, adults from 134 hospitals and medical centers in 26 countries were randomly assigned in a 1:1 ratio to receive either 1,200 mg of intravenous atezolizumab plus 15 mg/kg of bevacizumab every 3 weeks for 17 cycles (n = 334) or active surveillance (n = 334). At the prespecified interim analysis, the median duration of follow-up was 17.4 months. Atezolizumab plus bevacizumab was found to significantly improve recurrence-free survival compared with active surveillance (median, not evaluable vs not evaluable; hazard ratio = 0.72; P = .012).
The safety-evaluable population comprised 332 and 330 patients who received atezolizumab plus bevacizumab and active surveillance, respectively. More adverse events of grade 3 or 4 were documented with atezolizumab plus bevacizumab than with active surveillance (41% vs 13%). The investigators reported six adverse events of grade 5 with atezolizumab plus bevacizumab (2%), of which two were deemed treatment-related; one patient who received active surveillance had died (< 1%). A total of 9% of those who were administered atezolizumab plus bevacizumab discontinued such treatment because of adverse events.
“These results might affect recommendations for clinical practice and could lead to new considerations in clinical indications for surgical resection,” the investigators concluded. “However, longer follow-up for both recurrence-free and overall survival is needed to assess the benefit-risk profile more fully.”
Disclosure: For full disclosures of the study authors, visit thelancet.com.