FDA Approves Atezolizumab–Bevacizumab Combo for Unresectable or Metastatic HCC
On May 29, 2020, the FDA approved atezolizumab plus bevacizumab (Tecentriq and Avastin; Genentech) as a combination therapy for patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received systemic therapy.
The application for this approval was granted priority review and Breakthrough Therapy designation by the FDA.
This approval was based on efficacy data from the multi-center, open-label IMbrave150 clinical trial of 501 patients with locally advanced, unresectable or metastatic HCC not treated previously with systemic therapy.
These patients were randomized in a 2:1 ratio to receive atezolizumab 1200 mg followed by bevacizumab 15 mg/kg every 3 weeks or sorafenib twice daily.
The main efficacy end points were overall survival (OS) and independent review facility (IRF)-assessed progression-free survival (PFS). IRF-assessed overall response rate (ORR) was also evaluated.
Findings showed that the median OS was not reached in the patients given atezolizumab plus bevacizumab and was 13.2 months (95% CI, 10.4 to not estimable) in recipients of sorafenib (hazard ratio [HR], 0.58; 95% CI, 0.42-0.79; P = .0006).
The median PFS was estaimated to be 6.8 months (95% CI, 5.8-8.3) with atezolizumab plus bevacizumab versus 4.3 months (95% CI, 4.0-5.6) with sorafenib (HR, 0.59; 95% CI, 0.47-0.76; P <.0001). The ORR was found to be 28% (95% CI, 23-33) versus 12% (95% CI, 7-17), respectively (P <.0001). When evaluated per modified RECIST criteria, the ORR was 33% (95% CI, 28-39) compared with 13% (95% CI, 8-19), respectively (P <.0001).
The most common (≥20%) adverse reactions reported with the combination regimen were hypertension, fatigue, and proteinuria.— Kaitlyn Manasterski & Hina Porcelli
Source: US Food and Drug Administration. FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma. Updated June 1, 2020. www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-atezolizumab-plus-bevacizumab-unresectable-hepatocellular-carcinoma. Accessed June 1, 2020.