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The FDA on Friday approved the PD-L1 immune checkpoint inhibitor atezolizumab (Tecentriq) for the of unresectable or metastatic liver cancer, in combination with bevacizumab (Avastin), an inhibitor of the VEGF receptor.

Approval was based on findings from IMbrave150, a phase III trial that randomized 501 hepatocellular carcinoma (HCC) patients 2:1 to either 1,200 mg atezolizumab plus 15 mg/kg bevacizumab (administered intravenously every 3 weeks) or oral sorafenib (Nexavar) given twice daily, and showed improved survival outcomes and response rates with the combination.

"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," Richard Finn, MD, of the David Geffen School of Medicine at UCLA, said in a press release from drugmaker Genentech. "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."

Median overall survival was not reached among the group treated with the immunotherapy-based combination, as compared with 13.2 months with the kinase inhibitor sorafenib (HR 0.58, 95% CI 0.42-0.79, P=0.0006), as was median progression-free survival (6.8 vs 4.3 months, respectively; HR 0.59, 95% CI 0.47-0.76, P<0.0001).

Objective response rates per RECIST 1.1 were reported in 28% of patients in the combination arm compared to 12% of those on the sorafenib arm. By mRECIST, response rates were 33% versus 13%, respectively (P<0.0001 for both).

Common adverse events (AEs) with the combination included hypertension (29.8%), fatigue (20.4%), and proteinuria (20.1%). Incidence of grade 3/4 AEs was similar between the two arms, at 56.5% with the combination and 55.1% of those treated with sorafenib, though serious AEs were slightly more frequent with atezolizumab-bevacizumab (38.0% vs 30.8%), and included gastrointestinal bleeding, infections, and fever.

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