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Phase III LEAP-002 Study of Lenvatinib Alone or With Pembrolizumab in Advanced Liver Cancer

By: Sarah Campen, PharmD
Posted: Tuesday, October 4, 2022

Results from the phase III LEAP-002 study support the use of lenvatinib monotherapy in the first-line setting of advanced hepatocellular carcinoma, according to data presented at the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract LBA34). However, the combination of lenvatinib plus pembrolizumab did not meet prespecified statistical significance for the dual endpoints of overall survival and progression-free survival, reported Richard S. Finn, MD, of the University of California, Los Angeles, and colleagues.

In this double-blind, global study, 794 patients with advanced hepatocellular carcinoma were randomly assigned to receive first-line therapy with lenvatinib plus pembrolizumab (n = 395) or lenvatinib plus placebo (n = 399). At the data cutoff, after a median follow-up of 32.1 months, 9.1% and 6.1% of patients in each cohort, respectively, remained on study treatment.

At the final analysis, the median overall survival with lenvatinib plus pembrolizumab was 21.2 months compared with 19.0 months with lenvatinib plus placebo (hazard ratio = .840, 95% confidence interval = 0.708–0.997). The corresponding P value was .0227, higher than the prespecified boundary of .0185. Median progression-free survival with lenvatinib plus pembrolizumab versus lenvatinib plus placebo was similar (8.2 vs. 8.1 months), and the objective response rate was 26.1% versus 17.5%, respectively.

As for toxicity, no new safety signals were observed. Grade 3 to 5 treatment-related adverse events were reported in 62.5% of patients who received lenvatinib plus pembrolizumab compared with 57.5% of those who received lenvatinib plus placebo; grade 5 treatment-related adverse events occurred in 1.0% versus 0.8% of patients, respectively.

Disclosure: For full disclosures of the study authors, visit

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