RESEARCH SUMMARY 

Study Title: 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

Publication:The Lancet Oncology: February 27, 2023, 6:30 PM ET 

Dana-Farber Cancer Institute author: Toni Choueiri, MD

Summary:

The phase 3 CLEAR study results showed significant benefits in patients with advanced renal cell carcinoma (kidney cancer) from the combination comprised of lenvatinib, an oral kinase inhibitor that targets proteins involved in the formation of blood vessels supplying a tumor, and pembrolizumab, a checkpoint inhibitor given by infusion that helps the immune system attack the cancer. Results from the phase 3 trial were initially reported in The New England Journal of Medicine in April 2021. Now, extended follow-up is reported in The Lancet Oncology. The follow-up shows lenvatinib plus pembrolizumab yields better progression-free survival (23.3 months) than single-agent sunitinib (9.2 months) when given as a first-line therapy in untreated patients with metastatic kidney cancer. The follow-up also shows overall survival improved with the combination compared to single-agent sunitinib.

Impact:

The data presented here align with the initial results of the primary analysis of the CLEAR trial. This supports the use of lenvatinib plus pembrolizumab as a standard-of-care first-line treatment for patients with renal cell carcinoma. Upon extended follow-up, progression-free survival, overall survival, and objective response rate, all are in favor of the combination of lenvatinib plus pembrolizumab over sunitinib.

Funding:

Eisai and Merck Sharp & Dohme