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LAUNCH: TACE plus lenvatinib efficacious in advanced HCC

Presented By
Prof. Ming Kuang, Sun Yat-sen University, China
ASCO GI 2022
Phase 3, LAUNCH
Lenvatinib plus transarterial chemoembolisation (TACE) may represent a novel frontline therapy for patients with advanced hepatocellular carcinoma (HCC). The phase 3 LAUNCH trial demonstrated the superiority of this combination regimen over lenvatinib monotherapy, with an acceptable safety profile [1].

Prof. Ming Kuang (Sun Yat-sen University, China) explained that TACE reduces tumour burden swiftly in patients with advanced HCC but with potential post-treatment neovascularisation and subsequent tumour recurrence and metastasis. Lenvatinib inhibits angiogenesis and tumour cell proliferation. Therefore, Prof. Kuang argued that the assessment of a TACE plus lenvatinib combination in advanced HCC is reasonable. The multicentre, phase 3 LAUNCH trial (NCT03905967) randomised patients with advanced HCC (n=338) 1:1 to lenvatinib monotherapy 8 mg (bodyweight <60 kg) or 12 mg (bodyweight ≥60 kg) once daily, or lenvatinib plus TACE. The primary endpoint was overall survival (OS), and the secondary endpoint was time to progression.

The objective response rate was significantly higher in the lenvatinib plus TACE arm compared with the lenvatinib monotherapy arm (45.9% vs 20.8%; P<0.001). Also, the median OS favoured the TACE arm over the lenvatinib arm (17.8 vs 11.5 months; HR 0.45). Similarly, the median progression-free survival demonstrated superiority of the combination regimen over monotherapy (10.6 vs 6.4 months; HR 0.43). These results were consistent across the majority of pre-defined subgroups. In addition, patients in the TACE arm had a significantly longer median duration of lenvatinib exposure (8.2 vs 5.1 months; P=0.025). Notably, after treatment discontinuation, 26 patients in the combination arm versus 3 patients in the monotherapy arm underwent curative surgical resection (P<0.001).

Certain adverse events (AEs) were significantly more common in the combination arm, namely abdominal pain, nausea, fever, ascites, vomiting, and hypoalbuminaemia. Also, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), and hyperbilirubinaemia were more frequently reported as grade 3 or 4 events in the TACE arm. However, Prof. Kuang added that the AEs disappeared after 2 weeks of treatment.

In conclusion, lenvatinib plus TACE demonstrated superior efficacy over lenvatinib alone with an acceptable safety profile. Thus, representing a new potential first-line therapy for patients with advanced HCC.

  1. Peng Z, et al. Lenvatinib plus Transarterial Chemoembolization versus Lenvatinib alone as first-line treatment for Primary Advanced Hepatocellular Carcinoma: A Phase 3, Multicenter, Randomized Controlled Trial (LAUNCH). Abstract 380, ASCO GI 2022, 20–22 January.


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