Real-world outcomes with avelumab + axitinib in patients with advanced renal cell carcinoma in Japan: subgroup analyses from the J-DART2 study by International Metastatic Renal Cell Carcinoma Database Consortium risk classification.

This approval was based on results from the phase 3 JAVELIN Renal 101 trial ( NCT02684006 ), which demonstrated significantly longer median progression-free survival (PFS) and a higher objective response rate (ORR) with avelumab + axitinib vs sunitinib, the prior standard of care in aRCC; median overall survival (OS) favored avelumab + axitinib vs sunitinib, but differences did not reach statistical significance [ 11 – 14 ].

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