On May 29, 2020, the FDA approved the monoclonal antibody atezolizumab in combination with the vascular endothelial growth inhibitor factor bevacizumab (Tecentriq and Avastin, Genentech) for patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The approval of this combination was based on the results of the multicenter, open-label, phase III IMbrave150 study, which was recently published in The New England Journal of Medicine.

Patients with unresectable HCC who had not previously received systemic treatment were randomly assigned in a 2:1 ratio to receive either atezolizumab plus bevacizumab or sorafenib until unacceptable toxic effects occurred or there was a loss of clinical benefit. The coprimary endpoints were overall survival (OS) and progression-free survival (PFS) in the intention-to-treat population, as evaluated at an independent review facility according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). 

Results from the phase III IMbrave150 study demonstrated that atezolizumab in combination with bevacizumab reduced the risk of death (OS) by 42% (hazard ratio [HR] = 0.58; 95% CI, 0.42-0.79; P = .0006) and reduced the risk of disease worsening or death (PFS) by 41% (HR = 0.59; 95% CI,  0.47-0.76; P <.0001), compared with sorafenib. IMbrave150 is the first phase III cancer immunotherapy study to demonstrate an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. 

Serious adverse reactions (grade 3-4) occurred in 38% of individuals in the atezolizumab and bevacizumab arm. The most common serious adverse reactions (≥2%) were bleeding in the gastrointestinal tract, infections, and fever. The researchers concluded that in patients with unresectable HCC, atezolizumab combined with bevacizumab resulted in better OS and PFS outcomes than sorafenib. 

In a press release, lead author, 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, said, “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. 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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