Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma.
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Embargo End Date
ICR Authors
Authors
Choueiri, TK
Motzer, RJ
Rini, BI
Haanen, J
Campbell, MT
Venugopal, B
Kollmannsberger, C
Gravis-Mescam, G
Uemura, M
Lee, JL
Grimm, M-O
Gurney, H
Schmidinger, M
Larkin, J
Atkins, MB
Pal, SK
Wang, J
Mariani, M
Krishnaswami, S
Cislo, P
Chudnovsky, A
Fowst, C
Huang, B
di Pietro, A
Albiges, L
Motzer, RJ
Rini, BI
Haanen, J
Campbell, MT
Venugopal, B
Kollmannsberger, C
Gravis-Mescam, G
Uemura, M
Lee, JL
Grimm, M-O
Gurney, H
Schmidinger, M
Larkin, J
Atkins, MB
Pal, SK
Wang, J
Mariani, M
Krishnaswami, S
Cislo, P
Chudnovsky, A
Fowst, C
Huang, B
di Pietro, A
Albiges, L
Document Type
Journal Article
Date
2020-08-01
Date Accepted
2020-04-13
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.
Citation
Annals of oncology : official journal of the European Society for Medical Oncology, 2020, 31 (8), pp. 1030 - 1039
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Publisher
ELSEVIER
ISSN
0923-7534
eISSN
1569-8041
Collections
Research Team
Melanoma and Kidney Cancer