The following is a summary of “Lenvatinib Combined With Transarterial Chemoembolization as First-Line Treatment for Advanced Hepatocellular Carcinoma: A Phase III, Randomized Clinical Trial (LAUNCH),” published in the January 2023 issue of Oncology by Peng, et al.

Lenvatinib (LEN) is the first-line treatment for those with advanced hepatocellular carcinoma (HCC). However, studies only found minor improvements in survival. Therefore, for a study, researchers sought to assess the clinical effects of LEN combined with transarterial chemoembolization (LEN-TACE) to LEN monotherapy in patients with advanced HCC.

The phase III study was a multicenter, randomized, open-label, parallel group. LEN + on-demand TACE (LEN-TACE) or LEN monotherapy were randomly allocated (1:1) to patients with primary treatment-naive or first recurrent advanced HCC following surgery. Within three days of receiving a random assignment, participants were given LEN (starting dose: 12 mg once a day for patients ≥60 kg; 8 mg once daily for patients <60 kg). One day following the launch of LEN, TACE was launched. Overall survival (OS) was the main goal.

A total of 338 patients were randomly assigned between June 2019 and July 2021 at 12 locations in China: 170 to LEN-TACE and 168 to LEN. The median OS was considerably longer in the LEN-TACE group at a predetermined event-driven interim analysis following a median follow-up of 17.0 months (17.8 v 11.5 months; hazard ratio, 0.45; P< .001). In the LEN-TACE group, the median progression-free survival was 10.6 months, whereas, in the LEN group, it was 6.4 months (hazard ratio, 0.43; P< .001). According to the modified RECIST, patients in the LEN-TACE group had a higher objective response rate (54.1% vs. 25.0%, P< .001). Portal venous tumor thrombus and treatment allocation were identified as independent risk variables for OS by multivariable analysis.

For patients with advanced HCC, the inclusion of TACE to LEN enhanced clinical results and may be the first line of therapy.

Reference: ascopubs.org/doi/full/10.1200/JCO.22.00392