The Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab; Genentech) in combination with Avastin® (bevacizumab; Genentech) for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The application review was conducted under the FDA’s Project Orbis initiative and Real-Time Oncology Review pilot program.

The approval was based on data from the multicenter, open-label phase 3 IMbrave150 study that compared the efficacy and safety of atezolizumab, a programmed death-ligand 1 blocking antibody, in combination with bevacizumab, a vascular endothelial growth factor inhibitor, to sorafenib in 501 patients with unresectable and/or metastatic HCC who had not received prior systemic therapy. Patients were randomized 2:1 to receive either atezolizumab as an intravenous infusion followed by bevacizumab, on the same day every 3 weeks or sorafenib orally twice daily, until disease progression or unacceptable toxicity. The co-primary end points were overall survival (OS) and independent review facility (IRF)-assessed progression free survival (PFS) using RECIST v1.1.

Results showed that treatment with atezolizumab plus bevacizumab was associated with improvement in OS (hazard ratio [HR] 0.58; 95% CI, 0.42-0.79; P=.0006) and PFS (HR 0.59; 95% CI, 0.47-0.76; P <0.0001), compared with sorafenib. Median PFS was 6.8 months (95% CI, 5.8-8.3) in the combination group and 4.3 months (95% CI, 4.0-5.6) in the sorafenib arm.

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With regard to safety, 38% of patients treated with atezolizumab plus bevacizumab experienced serious adverse reactions (Grade 3-4). The most common serious adverse reactions (≥2%) in the atezolizumab plus bevacizumab arm were gastrointestinal hemorrhage, infections and pyrexia.

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“The results of the IMbrave150 study are really transformative for patients with advanced liver cancer, one of the few cancers with a rising death rate and limited options in the first-line setting,” said Dr Richard Finn, Professor of Medicine at the David Geffen School of Medicine at UCLA and Director of the Signal Transduction and Therapeutics Program at the UCLA Jonsson Comprehensive Cancer Center. “For the first-time we have a regimen that markedly improves survival over sorafenib, the standard of care for first-line hepatocellular carcinoma since 2007, and offers patients the opportunity for improved disease control with a favorable tolerability profile.”

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This article originally appeared on MPR