Choueiri Discusses Results of CLEAR Substudy of Lenvatinib Plus Pembrolizumab in RCC

At 2022 ASCO GU, Toni K. Choueiri, MD, discussed the CLEAR study and how East Asian patients with renal cell carcinoma derived similar benefit with lenvatinib plus pembrolizumab as the overall trial population.

During the 2022 Genitourinary Cancers Symposium, CancerNetwork® spoke with Toni K. Choueiri, MD, director of Lank Center for Genitourinary Oncology and director of the Kidney Cancer Center at Dana-Farber Cancer Institute as well as Jerome and Nancy Kohlber Chair and Professor of Medicine at Harvard Medical School, about the CLEAR study (NCT02811861).1 This current analysis examined the safety of lenvatinib (Lenvima) plus pembrolizumab (Keytruda) vs sunitinib (Sutent) in a subgroup of East Asian patients with advanced renal cell carcinoma.


The CLEAR study was the first 3-arm study of the doublet of lenvatinib plus pembrolizumab or lenvatinib/everolimus versus sunitinib as standard of care. This led to lenvatinib plus pembrolizumab being approved based on, not just the PFS [progression-free survival], but an OS [overall survival] and response rate benefit.2 There were always questions since we started using target therapy, for over a decade now, if Asian patients will have a different profile, activity, or efficacy, but there was none here in the study. Lenvatinib plus pembrolizumab benefited patients from Asia and there was no difference compared to overall population.


1. Young Rha S, Choueiri TK, Matveev VB, et al. Efficacy and safety of lenvatinib (LEN) plus pembrolizumab (PEMBRO) versus sunitinib (SUN) in the East Asian subset of patients with advanced renal cell carcinoma (aRCC) from the phase 3 CLEAR trial. J Clin Oncol. 2022;40(suppl 6):338. doi 10.1200/JCO.2022.40.6_suppl.338

2. FDA approves lenvatinib plus pembrolizumab for advanced renal cell carcinoma. News Release. FDA. August 10, 2021. Accessed March 1, 2022.