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

BAVENCIO® (avelumab) + INLYTA® (axitinib) demonstrated superior progression-free survival (PFS) in the ITT population vs sunitinib

Since PFS was statistically significant in patients with PD-L1-positive tumors (HR: 0.61; 95% CI: 0.48, 0.79), it was then tested in all patients regardless of tumor PD-L1 expression (ITT population)

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

Exploratory subgroup analysis of prognostic factors for PFS in the intent-to-treat (ITT) population

The graph below depicts exploratory subgroup analyses, only some of which were prespecified, from the ITT population in JAVELIN Renal 101. Small patient numbers can be a limitation of subgroup analyses. These results are presented for descriptive purposes and cannot be interpreted as a demonstration of efficacy in any particular subgroup. The results show the variability of the observed treatment effect over several subgroups.1

BICR=blinded independent central review; CI=confidence interval; HR=hazard ratio; NE=not estimable; PD-L1=programmed death-ligand 1.

Overall survival (OS) data were immature at the time of data cutoff

  • With a median follow-up of 19 months, death occurred in 27% of the ITT population

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

BAVENCIO (avelumab) + INLYTA (axitinib) doubled the objective response rate (ORR) in the ITT population vs sunitinib

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*Confirmed ORR (CR + PR) is based on RECIST (Response Evaluation Criteria in Solid Tumors) v1.1 as defined by BICR with 2 measurements at least 4 weeks apart.

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.