Nexavar has been firmly established as the standard of care in advanced HCC since gaining approval in the US in 2007. However, it has steadily lost market share after the introduction of generics in 2020 (US), 2021 (EU), and 2022 (Japan). Additionally, Nexavar has faced strong competition from the combination of Tecentriq + bevacizumab, which was the first regimen to demonstrate both superior overall survival (OS) and progression-free survival (PFS) over Nexavar, in the Phase III IMbrave150 study. 

After demonstrating a PFS benefit and non-inferior OS to Nexavar in the Phase III REFLECT study, Lenvima became the second systemic therapy to be approved as a first-line treatment for HCC in 2018. The drug, however, has seen significant competition from Tecentriq + bevacizumab and Imfinzi + Imjudo in the first-line setting. The loss of revenue to these therapies was hoped to be mitigated by an approval for Lenvima + Keytruda; however, this combination failed to show a significant benefit over Lenvima monotherapy in the Phase III LEAP-002 trial. Lenvima is instead being investigated in locoregional HCC in combination with Keytruda and Imfinzi + Imjudo, and as a front-line treatment for advanced HCC in combination with nofazinlimab and Loqtorzi. 

This Datamonitor Healthcare report contains a Disease Analysis module.