Atezolizumab in combination with bevacizumab was approved by FDA for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
Tecentriq and Avastin are sponsored by Genentech, a unit of Roche.
Efficacy was investigated in IMbrave150 (NCT03434379), a multicenter, international, open-label, randomized trial in patients with locally advanced unresectable or metastatic hepatocellular carcinoma who had not received prior systemic therapy. A total of 501 patients were randomized (2:1) to receive either atezolizumab 1200 mg as an intravenous infusion followed by bevacizumab 15 mg/kg IV on the same day, every 3 weeks, or sorafenib orally twice daily.
The main efficacy outcome measures were overall survival (OS) and independent review facility -assessed progression-free survival per RECIST 1.1. Additional efficacy outcome measures were IRF-assessed overall response rate per RECIST 1.1 and mRECIST.
Median OS was not reached in the patients who received atezolizumab plus bevacizumab and was 13.2 months (95% CI: 10.4, NE) in the patients who received sorafenib (HR 0.58; 95% CI: 0.42, 0.79; p=0.0006). Estimated median PFS was 6.8 months (95% CI: 5.8, 8.3) vs. 4.3 months (95% CI: 4.0, 5.6), respectively (HR 0.59; 95% CI: 0.47, 0.76; p<0.0001). The ORR per RECIST 1.1 was 28% (95% CI: 23, 33) in the atezolizumab plus bevacizumab group compared with 12% (95% CI: 7,17) in the sorafenib group (p<0.0001). The ORR per mRECIST was 33% (95% CI: 28, 39) vs. 13% (95% CI: 8, 19), respectively (p<0.0001).
