Motzer RJ, et al. - In this phase 3 trial, researchers compared avelumab plus axitinib with the standard-of-care sunitinib in previously untreated patients with advanced renal-cell carcinoma. Avelumab plus axitinib led to significantly longer progression-free survival than sunitinib among patients who received these agents as first-line treatment for advanced renal-cell carcinoma.

• Patients were randomly assigned in a 1:1 ratio to receive avelumab (10 mg per kilogram of body weight) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle).
• Progression-free survival and overall survival among patients with programmed death ligand 1 (PD-L1)–positive tumors were the two independent primary end points.
• Progression-free survival in the overall population was the key secondary end point; objective response and safety were assessed as other end points.

• Researchers randomly assigned 886 patients to receive avelumab plus axitinib (442 patients) or sunitinib (444 patients).
• The median progression-free survival of 13.8 months with avelumab plus axitinib, as compared with 7.2 months with sunitinib was observed among the 560 patients with PD-L1–positive tumors (63.2%) (hazard ratio for disease progression or death, 0.61; 95% confidence interval [CI], 0.47 to 0.79; P<0.001); the median progression-free survival of 13.8 months, as compared with 8.4 months was observed in the overall population (hazard ratio, 0.69; 95% CI, 0.56 to 0.84; P < 0.001).
• Patients with PD-L1–positive tumors displayed the objective response rate of 55.2% with avelumab plus axitinib and 25.5% with sunitinib; at a median follow-up for overall survival of 11.6 months and 10.7 months in the two groups, death was reported for 37 patients and 44 patients, respectively.
• In 99.5% of patients in the avelumab-plus-axitinib group and in 99.3% of patients in the sunitinib group, adverse events were encountered; the groups had grade 3 or higher events in 71.2% and 71.5% of the patients, respectively.