Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma

T. K. Choueiri*, R. J. Motzer, B. I. Rini, J. Haanen, M. T. Campbell, B. Venugopal, C. Kollmannsberger, G. Gravis-Mescam, M. Uemura, J. L. Lee, M. O. Grimm, H. Gurney, M. Schmidinger, J. Larkin, M. B. Atkins, S. K. Pal, J. Wang, M. Mariani, S. Krishnaswami, P. CisloA. Chudnovsky, C. Fowst, B. Huang, A. di Pietro, L. Albiges

*Corresponding author for this work

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Background: The phase 3 JAVELIN Renal 101 trial (NCT02684006) demonstrated significantly improved progression-free survival (PFS) with first-line avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma (aRCC). We report updated efficacy data from the second interim analysis. Patients and methods: Treatment-naive patients with aRCC were randomized (1 : 1) to receive avelumab (10 mg/kg) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary end points were PFS and overall survival (OS) among patients with programmed death ligand 1–positive (PD-L1+) tumors. Key secondary end points were OS and PFS in the overall population. Results: Of 886 patients, 442 were randomized to the avelumab plus axitinib arm and 444 to the sunitinib arm; 270 and 290 had PD-L1+ tumors, respectively. After a minimum follow-up of 13 months (data cut-off 28 January 2019), PFS was significantly longer in the avelumab plus axitinib arm than in the sunitinib arm {PD-L1+ population: hazard ratio (HR) 0.62 [95% confidence interval (CI) 0.490–0.777]}; one-sided P < 0.0001; median 13.8 (95% CI 10.1–20.7) versus 7.0 months (95% CI 5.7–9.6); overall population: HR 0.69 (95% CI 0.574–0.825); one-sided P < 0.0001; median 13.3 (95% CI 11.1–15.3) versus 8.0 months (95% CI 6.7–9.8)]. OS data were immature [PD-L1+ population: HR 0.828 (95% CI 0.596–1.151); one-sided P = 0.1301; overall population: HR 0.796 (95% CI 0.616–1.027); one-sided P = 0.0392]. Conclusion: Among patients with previously untreated aRCC, treatment with avelumab plus axitinib continued to result in a statistically significant improvement in PFS versus sunitinib; OS data were still immature. Clinical Trial number: NCT02684006.

Original languageEnglish
Pages (from-to)1030-1039
Number of pages10
JournalAnnals of Oncology
Issue number8
Early online date25 Apr 2020
Publication statusPublished - Aug 2020

Bibliographical note

Copyright the Author(s) 2020. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.


  • avelumab
  • axitinib
  • immune checkpoint inhibitor
  • PD-L1
  • phase 3
  • renal cell carcinoma


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