Dr Llovet on the Efficacy of TACE With or Without Lenvatinib Plus Pembrolizumab in HCC

Josep Llovet, MD, director, Liver Cancer Program, professor, medicine, Division of Liver Diseases, the Icahn School of Medicine at Mount Sinai; professor, medicine-hepatic oncology, the University of Barcelona; professor, Research-ICREA, Liver Unit, IDIBAPS-Hospital Clínic of Barcelona, discusses treatment with transarterial chemoembolization (TACE) with or without lenvatinib (Lenvima) and pembrolizumab (Keytruda) in patients with intermediate-stage hepatocellular carcinoma (HCC). This combination was evaluated in the phase 3 LEAP-012 trial (NCT04246177), findings from which were presented at the 2024 ESMO Congress.

Llovet begins by stating that this study focused on patients with intermediate-stage HCC with liver-only disease, no vascular invasion, and no extrahepatic spread. A total of 480 patients were randomly assigned in a 1:1 ratio to receive TACE plus lenvatinib plus pembrolizumab or a dual placebo, he explains, noting that the primary end points of the trial were progression-free survival (PFS) and overall survival (OS).

The efficacy results were significant, according to Llovet. Patients in theTACE/lenvatinib/pembrolizumab arm (n = 237) experienced a clear PFS benefit compared with the placebo plus TACE group (n = 243), he continues. The median PFS was 14.6 months (95% CI, 12.6-16.7) in the TACE/lenvatinib/pembrolizumab arm vs 10.0 months (95% CI, 8.1-12.2) in the placebo arm (HR, 0.66; 95% CI, 0.51-0.84; P = .0002). Subgroup analyses demonstrated that this improvement in the TACE/lenvatinib/pembrolizumab arm was consistent across all prespecifiedsubgroups, Llovet reports.

The first interim OS analysis of this trial has been conducted, although the 151 events recorded across both arms were insufficient to support a final conclusion, he expands. Nonetheless, there was a positive trend favoring the TACE/lenvatinib/pembrolizumab (HR, 0.80; 95% CI, 0.57-1.11; P = .0867), Llovet says, adding that this trend was consistent across prespecified subgroups. The LEAP-012 findings highlight the potential of lenvatinib plus pembrolizumab and TACE as a treatment option for patients with intermediate-stage HCC, Llovet concludes.