dc.contributor.author | Choueiri, TK | |
dc.contributor.author | Motzer, RJ | |
dc.contributor.author | Rini, BI | |
dc.contributor.author | Haanen, J | |
dc.contributor.author | Campbell, MT | |
dc.contributor.author | Venugopal, B | |
dc.contributor.author | Kollmannsberger, C | |
dc.contributor.author | Gravis-Mescam, G | |
dc.contributor.author | Uemura, M | |
dc.contributor.author | Lee, JL | |
dc.contributor.author | Grimm, M-O | |
dc.contributor.author | Gurney, H | |
dc.contributor.author | Schmidinger, M | |
dc.contributor.author | Larkin, J | |
dc.contributor.author | Atkins, MB | |
dc.contributor.author | Pal, SK | |
dc.contributor.author | Wang, J | |
dc.contributor.author | Mariani, M | |
dc.contributor.author | Krishnaswami, S | |
dc.contributor.author | Cislo, P | |
dc.contributor.author | Chudnovsky, A | |
dc.contributor.author | Fowst, C | |
dc.contributor.author | Huang, B | |
dc.contributor.author | di Pietro, A | |
dc.contributor.author | Albiges, L | |
dc.date.accessioned | 2020-10-21T14:52:04Z | |
dc.date.issued | 2020-08 | |
dc.identifier.citation | Annals of oncology : official journal of the European Society for Medical Oncology, 2020, 31 (8), pp. 1030 - 1039 | |
dc.identifier.issn | 0923-7534 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/4187 | |
dc.identifier.eissn | 1569-8041 | |
dc.identifier.doi | 10.1016/j.annonc.2020.04.010 | |
dc.description.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. | |
dc.format | Print-Electronic | |
dc.format.extent | 1030 - 1039 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0 | |
dc.subject | Humans | |
dc.subject | Carcinoma, Renal Cell | |
dc.subject | Kidney Neoplasms | |
dc.subject | Antibodies, Monoclonal, Humanized | |
dc.subject | Sunitinib | |
dc.subject | Axitinib | |
dc.title | Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2020-04-13 | |
rioxxterms.versionofrecord | 10.1016/j.annonc.2020.04.010 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by-nc-nd/4.0 | |
rioxxterms.licenseref.startdate | 2020-08 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Annals of oncology : official journal of the European Society for Medical Oncology | |
pubs.issue | 8 | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.publication-status | Published | |
pubs.volume | 31 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Melanoma and Kidney Cancer | en_US |
dc.contributor.icrauthor | Larkin, James | en |