An interim analysis of the Chinese phase III LAUNCH trial was reported in the Journal of Clinical Oncology by Peng et al. The researchers found that the addition of transarterial chemoembolization to lenvatinib improved overall survival in patients with advanced hepatocellular carcinoma who were previously untreated or had initial recurrence of advanced disease after radical resection and had not received postoperative treatment.

Study Details

In the open-label multicenter trial, 338 patients were randomly assigned between June 2019 and July 2021 to lenvatinib at 12 mg once daily for patients weighing ≥ 60 kg or 8 mg once daily for those < 60 kg plus on-demand TACE (n  = 170) or lenalidomide alone (n = 168). TACE was initiated at 1 day after the start of lenvatinib. The 170 patients in the lenvatinib/TACE group received 560 TACE treatments, with a median number of 3 treatments per patient. The primary endpoint was overall survival.

Overall Survival

At a prespecified interim analysis after a median follow-up of 17.0 months, median overall survival was 17.8 months (95% confidence interval [CI] = 16.1–19.5 months) in the lenvatinib/TACE group vs 11.5 months (95% CI = 10.3–12.7 months) in the lenvatinib group (hazard ratio [HR]  = 0.45, 95% CI = 0.33–0.61, P < .001).

Median progression-free survival was 10.6 months (95% CI = 9.5–11.7 months) in the lenvatinib/TACE group vs 6.4 months (95% CI = 5.8-7.0 months) in the lenvatinib group (HR = 0.43, 95% CI = 0.34–0.55, P < .001). Objective response rates were 45.9% vs 20.8% on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (P < .001) and 54.1% vs 25.0% (P < .001) on modified RECIST criteria.

On multivariate analysis, allocation to the lenvatinib/TACE group was a significant predictor of improved overall survival (HR = 0.41, P < .001) and progression-free survival (HR = 0.38, P < .001). Presence of portal vein tumor thrombus (PVTT) was significantly associated with poorer overall survival (HR = 2.04, P < .001) and progression-free survival (HR = 1.90, P < .001). The hazard ratios for lenvatinib/TACE vs lenvatinib among 239 patients with PVTT were 0.34 (95% CI = 0.24–0.49) for overall survival and 0.31 (95% CI = 0.23–0.41) for progression-free survival.

Adverse Events

Adverse events of any grade that were significantly (all P < .05) more common in the lenvatinib/TACE group were abdominal pain (50.6 % vs 10.7 %), fever (38.8% vs 5.4%), nausea (35.9% vs 10.1%), aspartate aminotransferase (AST) increase (26.5% vs 6.5%), alanine aminotransferase (ALT) increase (21.2% vs 5.4%), hyperbilirubinemia (17.9% vs 9.5%), vomiting (17.6% vs 5.4%), hypoalbuminemia (14.3% vs 4.2%), and ascites (12.9% vs 4.2%). Grade 3 or 4 adverse events that were more common in the lenvatinib/TACE group were AST elevation (22.9% vs 1.8%, P < .001), ALT elevation (17.6% vs 1.2%, P < .001), and hyperbilirubinemia (9.4% vs 3.0%, P = .014).

The investigators concluded: “The addition of TACE to [lenvatinib] improves clinical outcomes and is a potential first-line treatment for patients with advanced [hepatocellular carcinoma].”

Ming Kuang, MD, PhD, Cancer Center, Center of Hepato-Pancreato-Biliary Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, is the corresponding author for the Journal of Clinical Oncology article.

Disclosure: The study was supported by Science and Technology Innovation 2030 Major Projects, Key Program of the National Natural Science Foundation of China, and others. For full disclosures of the study authors, visit ascopubs.org.