
A single-arm, phase 2 study sought to compare the efficacy of atezolizumab plus bevacizumab for patients with advanced hepatocellular carcinoma (aHCC) who were previously treated with lenvatinib versus those with no prior treatment.
Results of the study are being presented at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.
Atezolizumab plus bevacizumab is considered a standard of care for patients with untreated aHCC. While lenvatinib used to be the standard of care and remains a treatment option for these patients, no subsequent treatment is available with demonstrated comparable efficacy.
Takeshi Terashima, MD, PhD, and colleagues designed a single-center, open-label, single-arm, phase 2 study to evaluate the efficacy of atezolizumab plus bevacizumab in patients with aHCC previously treated with lenvatinib. A total of 26 patients were enrolled between November 2020 and October 2022 to receive atezolizumab 1200 mg and bevacizumab 15 mg/kg intravenously every 3 weeks.
The primary end point of the study was progression-free survival (PFS), and secondary end points included overall survival (OS), response rate, tumor control rate, and frequency of adverse events (AEs). The threshold and expected PFS were 3.0 months and 6.8 months, respectively, at a one-sided significance level of 0.05 and a statistical power of 80%, researchers noted.
Results of the analysis showed the median PFS was 9.7 months (90% CI, 5.10-14.24). Median OS was 17.23 months (90% CI, 3.18-27.85), and the response and tumor control rates were 34.6% and 69.2%, respectively.
Dr. Terashima and colleagues reported severe AEs in 23.1% of patients (n=6). The same percentage of patients discontinued treatment due to immune-related AEs or treatment-refractory ascites, and 38.5% of patients (n=10) required a withdrawal of treatment due to proteinuria.
No treatment-related deaths were reported.
“[Atezolizumab plus bevacizumab] for patients with aHCC previously treated with lenvatinib had a comparable efficacy to that in patients with no prior treatment,” researchers concluded, adding that “it may therefore be a treatment option for patients with advanced HCC previously treated with lenvatinib.”