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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)

Study Design

  • Administration of BAVENCIO and INLYTA was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator
  • Assessment of tumor status was performed at baseline, after randomization at 6 weeks, then every 6 weeks thereafter up to 18 months after randomization, and every 12 weeks thereafter until documented confirmed disease progression by BICR

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

*United States vs Canada/Western Europe vs the 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

In the JAVELIN Renal 101 Trial—a Phase 3, randomized, open-label, multicenter study (N=886)1

Selected patient characteristics in the ITT population

Median age 61 years

(range: 27 to 88 years of age)

38% ≥65 years

75% male

25% female


75% White2

15% Asian2

2% African American2

8% other/unknown2

ECOG PS 0 63.00%


ECOG PS 1 37.00%


PD-L1 positive 63.20%2


PD-L1 negative 28.40%2


PD-L1 not evaluable 8.40%2

The JAVELIN Renal 101 Trial included patients from all International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic risk groups1

  • IMDC risk groups were classified based on 6 prognostic factors that impact survival1
  • IMDC risk scores are defined according to the number of following risk factors present1:

Karnofsky Performance Status score of 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

  • Patients with favorable risk had an IMDC score of 0, those with intermediate risk had a score of 1 or 2, and those with poor risk had a score of 3 to 61

Geographic regions in the ITT population1

References: 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. 2. Data on file. Rockland, Mass: EMD Serono, Inc.

BICR=blinded independent central review, ECOG=Eastern Cooperative Oncology Group, PD-L1=programmed death-ligand 1, PS=performance status, RECIST=response evaluation criteria in solid tumors.