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Phase III Trial to Compare First-Line Lenvatinib Combinations in Metastatic Renal Cell Carcinoma

By: Meg Barbor, MPH
Posted: Wednesday, July 5, 2017

A currently recruiting phase III trial will evaluate the efficacy and safety of two different lenvatinib-based combinations versus sunitinib alone as first-line treatment in patients with advanced renal cell carcinoma (ClinicalTrials.gov identifier NCT02811861): one with everolimus and one with pembrolizumab. The methods and goals of this trial appeared in a poster session at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS4595).

The study will randomize 735 patients 1:1:1 to receive lenvatinib (20 mg/day) plus pembrolizumab (200 mg every 3 weeks); lenvatinib (18 mg/day) plus everolimus (5 mg/day); or sunitinib (50 mg/day for 4 weeks followed by 2 weeks off treatment). The primary endpoint is progression-free survival. Enrollment of 735 patients is planned.

According to Robert J. Motzer, MD, principal investigator of the study and medical oncologist at Memorial Sloan Kettering Cancer Center in New York, previous studies offer a strong scientific rationale for investigating lenvatinib-based combinations as possible first-line treatments in this patient population.

“Following the efficacy seen in the registrational trial that led to the [U.S. Food and Drug Administration] approval of the lenvatinib-everolimus combination for the treatment of advanced [renal cell carcinoma] following prior antiangiogenic therapy, and results of preclinical research showing that lenvatinib enhances the antitumor activity of [anti–programmed cell death protein 1] therapy, we look forward to the study of these combinations in the front-line setting for patients with advanced [renal cell carcinoma],” he said in a recent press release.