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First-line therapy with lenvatinib or sorafenib for patients with advanced hepatocellular cancer (HCC) has been replaced by immunotherapy-based combinations. These investigators report results of the LEAP-002 trial, an industry-sponsored, randomized trial comparing lenvatinib with or without pembrolizumab in patients with advanced HCC.
The 794 patients received oral lenvatinib daily (8 or 12 mg/kg, depending on bodyweight), combined with intravenous pembrolizumab (200 mg) or placebo every 3 weeks. Overall, 49% tested positive for hepatitis B and 23% tested positive for hepatitis C; 32% had liver disease related to alcohol, and 62% had extrahepatic disease. At a median of 32 months from randomization to the final data cutoff, the coprimary en…