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Combining transarterial chemoembolization (TACE) with lenvatinib (Lenvima) as first-line treatment for advanced hepatocellular carcinoma (HCC) prolonged survival compared with lenvatinib alone, the phase III LAUNCH trial showed.

Median overall survival (OS) significantly improved from 11.5 months with the tyrosine kinase inhibitor to 17.8 months with lenvatinib plus TACE (HR 0.45, 95% CI 0.33-0.61, P<0.001), reported Ming Kuang, MD, PhD, of Sun Yat Sen University in Guangzhou, China, and colleagues.

In addition, median progression-free survival (PFS) grew from 6.4 months to 10.6 months, respectively (HR 0.43, 95% CI 0.34-0.55), according to findings published in the .

In the TACE group, no survival difference was observed for patients receiving drug-eluting lenvatinib beads compared with conventional lenvatinib.

Benefit with the combination was seen across most subgroups, and the results suggest TACE-lenvatinib could be "a potential first-line treatment for patients with advanced HCC," Kuang and colleagues concluded.

But the results "do not change the standard of care in the United States," said Anthony B. El-Khoueiry, MD, of the USC Norris Comprehensive Cancer Center in Los Angeles, discussing the findings when they were first presented at this year's Gastrointestinal Cancers Symposium. Still, he called the results "intriguing" and said that LAUNCH "reinforces the feasibility of combined liver-directed and systemic therapy."

The study had several limitations, he noted, such as its younger population (median 54-56 years) and the high percentage of patients with hepatitis B (86-87%), which limits its broad applicability. Furthermore, he pointed out that the OS in the lenvatinib monotherapy arm underperformed compared with phase III trials involving sorafenib (Nexavar), and that the systemic therapy backbone used in the study is not the current standard of care.

LAUNCH was a randomized, open-label phase III trial conducted from June 2019 to July 2021 at 12 hospitals across China. Overall, 338 patients with primary treatment-naive or initial recurrent advanced HCC after surgery were assigned 1:1 to receive lenvatinib plus on-demand TACE or lenvatinib monotherapy.

After a median follow-up of 17 months, 44.1% of patients in the lenvatinib-TACE group had died versus 61.9% of those in the lenvatinib group.

In general, the two groups had balanced baseline characteristics.

In addition to the survival outcomes described above, the overall response rates were 45.9% in the lenvatinib-TACE group and 20.8% in the lenvatinib group, according to RECIST 1.1 (P<0.001).

Multivariable analyses identified portal vein tumor thrombus (HR 2.04) and treatment allocation (HR 0.41) as independent risk factors for both OS and PFS (HR 1.90 and HR 0.38, respectively; P<0.001 for all).

As for safety, grade 3/4 adverse events (AEs) were more common in the lenvatinib-TACE group, with significantly higher AEs including alanine transaminase elevations (17.6% vs 1.2% with lenvatinib alone), aspartate aminotransferase elevations (22.9% vs 1.8%), and hyperbilirubinemia (9.4% vs 3.0%). Dose reductions for AEs occurred in 52.9% of patients assigned lenvatinib-TACE and 44.6% of those on lenvatinib alone.

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