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Soo Park, MD
Soo Park, MD
Posted: Friday, August 23, 2024
Use of the tyrosine kinase inhibitor lenvatinib plus the PD-1 inhibitor pembrolizumab in patients with advanced melanoma that progressed on anti–PD-L1 treatment has shown antitumor activity; however, long-term follow-up results have yet to be reported. In a study presented at the 2024 American Society of Oncology (ASCO) Annual Meeting (Abstract 9559), researchers presented findings from the LEAP-004 study with more than 4 years of follow-up. Ana Maria Arance, MD, PhD, of the Hospital Clinic Barcelona and IDIBAPS, Barcelona, and colleagues reported an objective response rate of 24.3%, a 24-month median overall survival rate of 29.7%, and no changes in safety compared with previous findings.
A total of 103 patients with unresectable stage III or IV melanoma were included in this phase II LEAP-004 study (ClinicalTrials.gov identifier NCT03776136). Patients received daily oral lenvatinib at 20 mg plus 35 or more doses of intravenous pembrolizumab once every 3 weeks at 200 mg.
The objective response rate was 24.3% (95% confidence interval [CI] = 16.4%–33.7%) in the overall population, with 5 patients having a complete response and 20 patients having a partial response. Subgroup findings revealed objective response rates of 33.3% in patients with disease progression on prior anti–PD-1 plus anti–CTLA-4 therapy and 10.7% (95% CI = 2.3%–28.2%) in patients with BRAF-mutant tumors who received prior BRAF/MEK-directed therapy. The median duration of response in the overall population was 8.5 months (range, 3.2–40.8 months), and the median progression-free survival was 4.2 months (95% CI = 3.5–6.3 months). Safety findings revealed grade 3 to 5 treatment-related adverse events in 49.5% of patients, a finding that was consistent with previous work.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
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