Axitinib/avelumab combo shows preliminary efficacy in RCC

The study, known as JAVELIN Renal 100, was a phase 1b investigation that included 55 patients with advanced clear-cell RCC. A total of 6 patients were enrolled in a smaller dose-finding cohort, and 49 were enrolled in a dose-expansion cohort.

In the dose-finding phase, patients received oral axitinib 5 mg twice a day for 7 days, at which point they started intravenous avelumab 10 mg/kg every 2 weeks, according to the study description. In the dose-expansion phase, patients were directly started on the combination.

Out of 55 patients enrolled, 26 (53%) had a response on the axitinib-avelumab combination, including 3 (6%) who had complete responses, investigators reported.

Grade 3 or greater treatment-related adverse events were reported in 32 patients (58%). The most common of those was hypertension, occurring in 16 patients (29%), followed by ALT increase and palmar-plantar erythrodysesthesia syndrome in 4 patients each (7%), Dr. Choueiri and colleagues wrote.