The phase 3 JAVELIN Renal 101 trial (NCT02684006) demonstrated significantly improved progression-free survival (PFS) with first-line avelumab plus axitinib vs sunitinib in advanced renal cell carcinoma (aRCC). We report updated efficacy data from the second interim analysis.
Treatment-naïve patients with aRCC were randomized (1:1) to receive avelumab (10 mg/kg) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary endpoints were PFS and overall survival (OS) among patients with PD-L1+ tumors. Key secondary endpoints were OS and PFS in the overall population.
Of 886 patients, 442 were randomized to the avelumab plus axitinib arm and 444 to the sunitinib arm; 270 and 290 had PD-L1+ tumors, respectively. After a minimum follow-up of 13 months (data cutoff Jan 28, 2019), PFS was significantly longer in the avelumab plus axitinib arm than in the sunitinib arm (PD-L1+ population: hazard ratio [HR] 0.62 [95% CI, 0.490-0.777]; 1-sided P < 0.0001; median 13.8 [95% CI, 10.1-20.7] vs 7.0 months [95% CI, 5.7-9.6]; overall population: HR 0.69 [95% CI, 0.574-0.825]; 1-sided P < 0.0001; median 13.3 [95% CI, 11.1-15.3] vs 8.0 months [95% CI, 6.7-9.8]). OS data were immature (PD-L1+ population: HR 0.828 [95% CI, 0.596-1.151]; 1-sided P = 0.1301; overall population: HR 0.796 [95% CI, 0.616-1.027]; 1-sided P = 0.0392).
Among patients with previously untreated aRCC, treatment with avelumab plus axitinib continued to result in a statistically significant improvement in PFS vs sunitinib; OS data were still immature.

Copyright © 2020. Published by Elsevier Ltd.