Efficacy and safety of avelumab plus axitinib (A + Ax) versus sunitinib (S) in elderly patients with advanced renal cell carcinoma (aRCC): Extended follow-up results from JAVELIN Renal 101

In the phase III JAVELIN Renal 101 trial, A + Ax demonstrated significantly longer progression-free survival (PFS) and a higher objective response rate versus S in patients with previously untreated aRCC. The study team reported the efficacy of A + Ax versus S by age group (<65, ≥65 to <75, and ≥75) from the second interim analysis (IA) of overall survival (OS) and the safety of A + Ax by age group from the first IA.

The proportion of IMDC risk groups was generally well balanced between the A + Ax and S arm in each age group, although in the 75 and older group, the frequency of patients with intermediate risk was slightly higher in the A + Ax arm, and that of patients with favorable risk was slightly higher in the S arm. At data cut-off for the second IA, median follow-up for OS and PFS was 19.3 versus 19.2 months and 16.8 versus 15.2 months for the A + Ax vs S arm, respectively. In the A + Ax arm, the most common treatment-emergent adverse events (AEs) were diarrhea, hypertension, palmar-plantar erythrodysesthesia syndrome, fatigue, and nausea in each age group. Grade ≥3 treatment-emergent AEs and immune-related AEs were observed in 69%, 74%, 73% and 39%, 40%, 24% of patients in each age group, respectively.

A + Ax demonstrated favorable efficacy across age groups, including patients aged ≥75. OS was still immature; follow-up for the final analysis is ongoing. The safety profile was generally consistent between age groups.