Kidney Cancer Coverage from Every Angle

CLEAR Trial in Advanced Kidney Cancer: Subgroup and Toxicity Update on Lenvatinib Plus Pembrolizumab

By: Lauren Harrison, MS
Posted: Monday, October 18, 2021

A data analysis from the phase III CLEAR trial, presented during the European Society for Medical Oncology (ESMO) Congress 2021, lenvatinib plus pembrolizumab showed efficacy benefits over sunitinib in patients with advanced renal clear cell carcinoma who had adverse features (Abstract 660P). Toni K. Choueiri, MD of the Dana-Farber Cancer Institute, Boston, presented both subgroup and toxicity results from this study on behalf of his colleagues.

This trial enrolled 1,069 patients with advanced renal clear cell carcinoma who had not received prior therapy. Patients were randomly assigned 1:1:1 to receive one of three therapies: 20 mg of oral lenvatinib daily plus 200 mg of intravenous pembrolizumab every 3 weeks, 18 mg of oral lenvatinib daily plus 5 mg of oral everolimus daily, or 50 mg of oral sunitinib daily (4 weeks on and 2 weeks off). Patients both with and without adverse prognostic features were enrolled, including those with sarcomatoid histology, bone and/or liver metastases, and no prior nephrectomy.

The progression-free survival was consistently higher with lenvatinib plus pembrolizumab than with sunitinib across all subgroups. The objective response rate was 61% among patients with sarcomatoid histology treated with the doublet, whereas it was 24% for patients with the same histology given sunitinib (odds ratio = 8.9). Among the population with bone metastasis, the objective response rate for the combination therapy was 60% and 27% for sunitinib therapy (odds ratio = 4.1). Patients without a prior nephrectomy had an objective response rate of 63% on the dual therapy, compared with 23% for those given sunitinib (odds ratio = 6.3). Similar results were seen in patients without these features as well.

About 15% of patients in the Lenvatinib-plus-pembrolizumab group needed high-dose corticosteroid therapy for any duration to manage immune-related adverse events.

Disclosure: For a full list of authors’ disclosures, visit

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