Clinically meaningful improvement seen in progression-free survival for transarterial chemoembolization plus lenvatinib and pembrolizumab
By Elana Gotkine HealthDay Reporter
THURSDAY, Jan. 16, 2025 (HealthDay News) — For patients with unresectable, nonmetastatic hepatocellular carcinoma, transarterial chemoembolization (TACE) with the addition of lenvatinib and pembrolizumab is associated with improved progression-free survival, according to a study published online Jan. 8 in The Lancet.
Masatoshi Kudo, M.D., from Kindai University in Osaka, Japan, and colleagues conducted a multicenter, randomized, double-blind, phase 3 study involving patients with unresectable, nonmetastatic hepatocellular carcinoma recruited from 137 global sites in 33 countries or regions. Participants were randomly assigned to receive TACE and either oral lenvatinib plus intravenous pembrolizumab or matched dual placebo (237 and 243 individuals, respectively). Participants were followed for a median of 25.6 months.
The researchers found that median progression-free survival was 14.6 and 10.0 months for TACE with lenvatinib plus pembrolizumab and TACE plus placebo, respectively (hazard ratio, 0.66; 95 percent confidence interval, 0.51 to 0.84; one-sided P = 0.0002). Twenty-nine and 34 percent of patients in the TACE with lenvatinib plus pembrolizumab and TACE plus placebo groups died, with 24-month overall survival rates of 75 and 69 percent, respectively (hazard ratio, 0.80; 95 percent confidence interval, 0.57 to 1.11; P = 0.087). Grade 3 or worse treatment-related adverse events occurred in 71 and 32 percent of participants in the group receiving TACE with lenvatinib plus pembrolizumab and the group receiving TACE plus placebo, respectively, with the most common being hypertension (24 versus 7 percent) and decreased platelet count (11 versus 6 percent).
“Based on these data, lenvatinib plus pembrolizumab combined with TACE could be a new treatment option for patients with unresectable, nonmetastatic hepatocellular carcinoma,” the authors write.
Several authors disclosed ties to pharmaceutical companies, including Eisai and Merck, which manufacture lenvatinib and pembrolizumab, respectively, and funded the trial.
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