Avelumab plus axitinib

An open-label, phase III, randomized trial (NCT02684006) compared the combination of avelumab and axitinib with sunitinib monotherapy. The study included 560 patients with previously untreated stage IV PD-L1–positive renal cell carcinoma (the entire study population was 886 patients, including those who were PD-L1 negative).[11] This trial specified two primary end points: PFS and OS among patients with PD-L1-positive tumors. PFS among the entire study population was a secondary end point.

An open-label, phase III, randomized trial (NCT02684006) compared the combination of avelumab and axitinib with sunitinib monotherapy. The study included 560 patients with previously untreated stage IV PD-L1–positive renal cell carcinoma (the entire study population was 886 patients, including those who were PD-L1 negative).[11] This trial specified two primary end points: PFS and OS among patients with PD-L1-positive tumors. PFS among the entire study population was a secondary end point.

With a median follow-up of less than 1 year, there was no significant difference in OS between the two arms.

An open-label, phase III, randomized trial (NCT02684006) compared the combination of avelumab and axitinib with sunitinib monotherapy. The study included 560 patients with previously untreated stage IV PD-L1–positive renal cell carcinoma (the entire study population was 886 patients, including those who were PD-L1 negative).[11] This trial specified two primary end points: PFS and OS among patients with PD-L1-positive tumors. PFS among the entire study population was a secondary end point.

Among patients with PD-L1–positive tumors, the PFS was 13.8 months in the combination therapy arm, compared with 7.2 months in the sunitinib arm (HR, 0.61; 95% CI, 0.47–0.79).[11][Level of evidence B1]

An open-label, phase III, randomized trial (NCT02684006) compared the combination of avelumab and axitinib with sunitinib monotherapy. The study included 560 patients with previously untreated stage IV PD-L1–positive renal cell carcinoma (the entire study population was 886 patients, including those who were PD-L1 negative).[11] This trial specified two primary end points: PFS and OS among patients with PD-L1-positive tumors. PFS among the entire study population was a secondary end point.

For the entire study population, the median PFS was 13.8 months in the combination arm, compared with 8.4 months in the sunitinib arm (HR, 0.69; 95% CI, 0.56–0.84).