LAUNCH trial LEN-TACE vs Len alone in adv. HCC

Background

Phase III RCT of 338 patients (China) who were primary treatment-naive or had initial recurrent advanced hepatocellular carcinoma. Child-Pugh A.

Interventions and follow up

Arm A: Lenvatinib 12 mg daily (8 mg if <60 kg) plus on-demand transarterial chemoembolization (TACE) initiated one day after lenvatinib (LEN-TACE)
Arm B: Lenvatinib 12 mg daily (8 mg if <60 kg)
Primary endpoint: Overall survival
mFollow up: 17 mo

Results

mOS: 17.8 mo (Arm A) vs 11.5 mo (Arm B); HR 0.45; P<.001
ORR: 54.1% vs 25.0%; P<.001
mPFS: 10.6 mo vs 6.4 mo; HR 0.43; P<.001
Multivariable analysis: Portal vein tumor thrombus and treatment allocation were independent risk factors for OS

Adverse events

Hepatic (grade 3-4, A vs B): ALT elevation 17.6% vs 1.2%; AST elevation 22.9% vs 1.8%; hyperbilirubinemia 9.4% vs 3.0%
Tolerability: Higher rate of liver-enzyme toxicity with LEN-TACE, consistent with the added embolization; otherwise toxicities were manageable

Conclusions

Adding on-demand TACE to lenvatinib significantly improved OS, PFS, and ORR, supporting LEN-TACE as a potential first-line option for advanced HCC.

Key Limitations

Single-country (China), predominantly HBV-related HCC, limiting generalizability; open-label; control arm was TKI monotherapy rather than current IO-based 1L standards; on-demand TACE protocol variability.

Clinical Context

LAUNCH supports combining systemic TKI therapy with locoregional TACE in selected advanced HCC, but it predates IO-based 1L standards (atezolizumab/bevacizumab, durvalumab/tremelimumab). Combination systemic-plus-locoregional strategies remain investigational in ESMO guidance and require validation against current IO backbones.

References