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Cited by 455

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

Open access
Choueiri, T.K., Motzer, R.J., Rini, B.I., Haanen, J., Campbell, M.T., Venugopal, B., Kollmannsberger, C., Gravis-Mescam, G., Uemura, M., Lee, J.L., Grimm, M.-O., Gurney, H., Schmidinger, M., Larkin, J., Atkins, M.B., Pal, S.K., Wang, J., Mariani, M., Krishnaswami, S., Cislo, P., Chudnovsky, A., Fowst, C., Huang, B., di Pietro, A., Albiges, L.·2020·Annals of Oncology

Abstract

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.

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Metadata

Authors
Choueiri, T. K., Motzer, R. J., Rini, B. I., Haanen, J., Campbell, M. T., Venugopal, B., Kollmannsberger, C., Gravis-Mescam, G., Uemura, M., Lee, J. L., Grimm, M.-O., Gurney, H., Schmidinger, M., Larkin, J., Atkins, M. B., Pal, S. K., Wang, J., Mariani, M., Krishnaswami, S., Cislo, P., Chudnovsky, A., Fowst, C., Huang, B., di Pietro, A., & Albiges, L.
Venue
Annals of Oncology
Publisher
Elsevier BV
Published
2020-08
Volume
31
Issue
8
Pages
1030-1039
ISSN
0923-7534 (ISSN-L)
OpenAlex
W3018979351
Cited by
455
References
14
FWCI
39.03
Type
journal article
Language
en
Open access
hybrid

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CoChat. (2026). Citation check: Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma. https://app.cochat.ai/papers/10.1016/j.annonc.2020.04.010
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Choueiri, T. K., Motzer, R. J., Rini, B. I., Haanen, J., Campbell, M. T., Venugopal, B., Kollmannsberger, C., Gravis-Mescam, G., Uemura, M., Lee, J. L., Grimm, M.-O., Gurney, H., Schmidinger, M., Larkin, J., Atkins, M. B., Pal, S. K., Wang, J., Mariani, M., Krishnaswami, S., . . . Albiges, L. (2020). Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma. Annals of Oncology. https://doi.org/10.1016/j.annonc.2020.04.010

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.