Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma
| Autor: | A. di Pietro, Jing Wang, Balaji Venugopal, Brian I. Rini, Camilla Fowst, J.-L. Lee, Bo Huang, Motohide Uemura, Mariangela Mariani, S. Krishnaswami, J.B.A.G. Haanen, Sumanta K. Pal, Marc-Oliver Grimm, Christian K. Kollmannsberger, Manuela Schmidinger, P. Cislo, Howard Gurney, Aleksander Chudnovsky, James Larkin, Michael B. Atkins, Matthew T. Campbell, Robert J. Motzer, Toni K. Choueiri, G. Gravis-Mescam, Laurence Albiges |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty Axitinib Population Urology Antibodies Monoclonal Humanized 03 medical and health sciences 0302 clinical medicine Renal cell carcinoma Sunitinib Humans Medicine education Carcinoma Renal Cell education.field_of_study business.industry Hazard ratio Hematology Interim analysis medicine.disease Kidney Neoplasms Confidence interval Clinical trial 030104 developmental biology Oncology 030220 oncology & carcinogenesis business medicine.drug |
| Zdroj: | Annals of Oncology. 31:1030-1039 |
| ISSN: | 0923-7534 |
| Popis: | 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.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.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 P0.0001; 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 P0.0001; 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].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.NCT02684006. |
| Databáze: | OpenAIRE |
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