In the JAVELIN Renal 101 Trial—a Phase 3, randomized, open-label, multicenter study (N=886)1
BAVENCIO® (avelumab) in combination with INLYTA® (axitinib) was studied in the first-line treatment of patients with advanced renal cell carcinoma (RCC)
If PFS was statistically significant in patients with PD-L1 positive tumors, it was then tested in the intent-to-treat (ITT) population, which included patients regardless of PD-L1 expression
BICR=blinded independent central review, RECIST=response evaluation criteria in solid tumors.
*United States vs Canada/Western Europe vs rest of the world.
†Assessed by BICR using RECIST v1.1.
‡PD-L1 expression level ≥1% of immune cells staining positive within the tumor area of the tested tissue sample by Ventana PD-L1 (SP263) assay.1
Patient characteristics from the JAVELIN Renal 101 Trial (N=886)
Patient distribution by prognostic risk group
Karnofsky Performance Status score less than 80, time from the initial diagnosis to randomization of less than 1 year, hemoglobin level below the lower limit of the normal range, corrected serum calcium level above the upper limit of the normal range, absolute neutrophil count above the upper limit of the normal range, and platelet count above the upper limit of the normal range
Reference: 1. Motzer RJ, Penkov K, Haanen J, et al. Avelumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2019;380(12):1103-1115.