For patients with advanced renal cell carcinoma, progression-free survival and overall survival are improved with lenvatinib plus pembrolizumab versus sunitinib, according to a study published in the March issue of The Lancet Oncology.
Toni K. Choueiri, M.D., from the Dana-Farber Cancer Institute in Boston, and colleagues conducted a protocol-prespecified updated overall survival analysis of the phase 3 CLEAR trial. Patients with clear-cell advanced renal cell carcinoma who had not received any systemic anticancer therapy were eligible and randomly assigned to receive lenvatinib plus pembrolizumab, lenvatinib plus everolimus, or sunitinib (355, 357, and 357, respectively). This updated analysis did not report on patients in the lenvatinib plus everolimus group.
The median follow-up for progression-free survival was 27.8 and 19.4 months in the lenvatinib plus pembrolizumab group and the sunitinib group, respectively. The researchers found that median progression-free survival was 23.3 and 9.2 months in the lenvatinib plus pembrolizumab group and sunitinib group, respectively (stratified hazard ratio, 0.42). For overall survival, median follow-up was 33.7 and 33.4 months in the lenvatinib plus pembrolizumab group and sunitinib group, respectively; overall survival was improved with lenvatinib plus pembrolizumab versus sunitinib (hazard ratio, 0.72).
“This extended follow-up analysis shows the durable and clinically meaningful efficacy benefit with lenvatinib plus pembrolizumab over sunitinib,” the authors write. “Previously observed benefits in overall survival, progression-free survival, and objective response rate were maintained.”
Several authors disclosed financial ties to biopharmaceutical companies, including Eisai and Merck, which manufacture lenvatinib (Eisai) and pembrolizumab (Merck) and funded the study.
Toni K Choueiri et al, Lenvatinib plus pembrolizumab versus sunitinib as first-line treatment of patients with advanced renal cell carcinoma (CLEAR): extended follow-up from the phase 3, randomised, open-label study, The Lancet Oncology (2023). DOI: 10.1016/S1470-2045(23)00049-9
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