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Dec 21, 2021

Exposure-Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma

Abstract

Purpose: A benefit:risk assessment for a less-frequent nivolumab 480 mg Q4W + cabozantinib 40 mg QD dosing regimen was predicted using modeling and simulation of clinical trial data from nivolumab monotherapy studies and from the nivolumab 240 mg Q2W + cabozantinib 40mg QD dosing regimen, which demonstrated clinical benefit versus sunitinib in previously untreated advanced renal cell carcinoma (aRCC) in the phase III CheckMate 9ER trial (NCT03141177).

Experimental design: Multivariable Cox proportional-hazards analyses were conducted using nivolumab monotherapy data in previously treated aRCC and data from CheckMate 9ER to evaluate progression-free survival (PFS), overall survival (OS), and grade {greater than or equal to}2 immune-mediated adverse events (IMAEs).

By Lora Hamuro, Zheyi Hu, Julie Passarell, Heather Barcomb, Joshua Zhang, Shay Goldstein, Akintunde Bello, Amit Roy, Li Zhu.

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