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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) efficacy results

Since PFS was statistically significant in patients with PD-L1 positive tumors (HR 0.61 [95% Cl: 0.48, 0.79]), it was then tested in the intent-to-treat (ITT) population and a statistically significant improvement in PFS in the ITT population was also demonstrated.

BAVENCIO in combination with INLYTA demonstrated superior PFS results vs sunitinib

ITT population
PFS based on BICR assessment (Kaplan-Meier estimates)

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Efficacy results from JAVELIN Renal 101 Trial—ITT population

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BICR=blinded independent central review; CI=confidence interval; NE=not estimable. 

*P value based on stratified log-rank.

Overall survival (OS)

  • With a median OS follow-up of 19 months, OS data were immature, with 27% deaths in the ITT population

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.