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GU Symposium 2021: CLEAR Trial of Lenvatinib and Pembrolizumab or Everolimus in Kidney Cancer

By: Lauren Harrison, MS
Posted: Friday, February 19, 2021

Treatment of advanced renal cell carcinoma using lenvatinib plus pembrolizumab or everolimus showed improvements in progression-free survival and objective response rate when compared with sunitinib monotherapy, based on the latest findings from the phase III CLEAR trial. Toni Choueiri, MD, of the Dana-Farber Cancer Institute, Boston, presented the work he completed with his colleagues during the virtual 2021 Genitourinary (GU) Cancers Symposium (Abstract 269).

“The rate of responses and complete responses and the progression-free survival were the longest we have seen to date in a phase III combination of a targeted VEGF inhibitor and an immune checkpoint inhibitor,” said Dr. Choueiri in an institutional press release.

A total of 1,069 patients with advanced renal cell carcinoma who had never had prior therapy were recruited to the study. Patients were randomly assigned 1:1:1 to receive one of the following regimens: 20 mg of oral lenvatinib once a day plus 200 mg of intravenous pembrolizumab every 3 weeks, 18 mg of oral lenvatinib plus 5 mg of oral everolimus daily, or 50 mg of oral sunitinib once a day (4 weeks on, 2 weeks off).

Progression-free survival was significantly improved with lenvatinib plus pembrolizumab (median, 24 months) or lenvatinib plus everolimus (median, 15 months) when compared with sunitinib (median, 9 months). Overall survival was also significantly longer with lenvatinib and pembrolizumab when compared with sunitinib (hazard ratio = 0.66); however, overall survival was not statistically different between lenvatinib/everolimus and sunitinib. The objective response rate for lenvatinib/pembrolizumab was 71%, with 16% achieving a complete response. In comparison, the objective response rates for lenvatinib/everolimus and sunitinib alone were 54% and 36%, respectively.

Grade 3 or higher treatment-related adverse events were seen in 72% of patients given lenvatinib and pembrolizumab, 73% of patients who received lenvatinib plus everolimus, and 59% of patients given sunitinib. These adverse events resulted in cessation of therapy in 37.2% of patients in the lenvatinib/pembrolizumab arm and dose reduction of lenvatinib in 68.5% of patients.

Disclosure: For a full list of author disclosures, visit coi.asco.org.



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