Transarterial chemoembolization with pembrolizumab and levatinib improves survival in unresectable hepatocellular carcinoma

1. Progression-free survival was significantly greater in the lenvatinib plus pembrolizumab group compared to placebo.

2. Overall survival was higher in the intervention group, though not statistically significant.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Transarterial chemoembolization (TACE) is the standard treatment for patients with unresectable, non-metastatic hepatocellular carcinoma. However, whether the addition of systemic chemotherapy and immunotherapy is beneficial remains uncertain. One approach is combining TACE with systemic therapies like lenvatinib and pembrolizumab to improve patient outcomes. This randomized controlled trial aimed to evaluate whether adding lenvatinib and pembrolizumab to TACE provides superior benefits compared to TACE alone. The primary outcome of this study was progression-free survival, while key secondary outcome was overall survival. According to study results, patients receiving lenvatinib and pembrolizumab plus TACE had significantly longer progression-free survival compared to those receiving TACE alone. Although this study was well done, it was limited by the need for longer follow-up to determine the impact on overall survival.

Click to read the study in The Lancet

Relevant Reading: Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma

In-depth [randomized controlled trial]: Between May 22, 2020, and Jan 11, 2023, 847 patients were assessed for eligibility across 137 global sites in 33 countries. Included were patients ≥ 18 years with unresectable hepatocellular carcinoma who were not eligible for curative treatment but had tumors amenable to TACE, an Eastern Cooperative Oncology Group performance status of 0 or 1, and Child-Pugh class A liver function. Altogether, 480 patients (237 receiving TACE plus lenvatinib and pembrolizumab and 243 receiving TACE plus placebo) were included in the final analysis. The primary outcome of progression-free survival was significantly improved in the lenvatinib plus pembrolizumab group compared to placebo (14.6 months vs. 10.0 months, hazard rate [HR] 0.66 [0.51-0.84], p<0.05). The secondary outcome of overall survival showed a similar trend (24-month survival rate of 75% vs. 69%), but this difference was not statistically significant (HR 0.80, p = 0.087). Findings from this study suggest that adding lenvatinib and pembrolizumab to TACE significantly improves progression-free survival in patients.

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