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

The phase 3 JAVELIN Renal 101 trial (NCT02684006) demonstrated significantly improved progression-free survival (PFS) with first-line avelumab plus axitinib vs sunitinib in advanced renal cell carcinoma (aRCC). We report updated efficacy data from the second interim analysis.

Treatment-naïve 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 endpoints were PFS and overall survival (OS) among patients with PD-L1+ tumors. Key secondary endpoints 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 cutoff Jan 28, 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% CI, 0.490-0.777]; 1-sided P < 0.0001; median 13.8 [95% CI, 10.1-20.7] vs 7.0 months [95% CI, 5.7-9.6]; overall population: HR 0.69 [95% CI, 0.574-0.825]; 1-sided P < 0.0001; median 13.3 [95% CI, 11.1-15.3] vs 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]; 1-sided P = 0.1301; overall population: HR 0.796 [95% CI, 0.616-1.027]; 1-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 vs sunitinib; OS data were still immature.

Annals of oncology : official journal of the European Society for Medical Oncology. 2020 Apr 24 [Epub ahead of print]

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, Paul Cislo, Aleksander Chudnovsky, Camilla Fowst, B Huang, Alessandra di Pietro, Laurence Albiges

Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, 450 Brookline Ave, Boston, MA 02215, USA;. Electronic address: ., Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY 10065, USA., Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, USA., Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam, 1066 CX, The Netherlands., The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA., University of Glasgow, Beatson West of Scotland Cancer Centre, 1053, Great Western Rd, Glasgow, G12 0YN, UK., British Columbia Cancer Agency, Vancouver Centre, 600 West 10th Avenue, Vancouver, BC, V5Z 4E6, Canada., Institut Paoli-Calmettes, Department of Medical Oncology, Aix-Marseille Université, Inserm, CNRS, CRCM, Marseille, France., Osaka University Hospital, 2-15 Yamadaoka, Suita, Osaka 565-0871, Japan., University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea., Jena University Hospital, Department of Urology, Am Klinikum 1, 07747 Jena, Germany., Macquarie University, F10A Building, 2 Technology Place, Suite 407, Level 4, Sydney, NSW, 2109, Australia., Medical University of Vienna; Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Waehringer Guertel 18-20, A-1090 Vienna, Austria., Royal Marsden NHS Foundation Trust, Fulham Rd, London SW3 6JJ, UK., Georgetown University Medical Center, 3800 Reservoir Rd NW, Washington, DC 20057, USA., City of Hope National Medical Center, 1500 E Duarte Rd, Duarte, CA 91010, USA., Pfizer, 300 Technology Square, Cambridge, MA 02138, USA., Pfizer Italia SRL, Via Anna Maria Mozzoni, 12, 20152 Milano, Italy., Pfizer, 445 Eastern Point Rd, Groton, CT 06340, USA., Pfizer, 235 E 42nd St, New York, NY 10017, USA., Pfizer Italia SRL, Via Anna Maria Mozzoni, 12, 20152 Milano, Lombardia, Italy., Institut Gustave Roussy, 114 rue Edouard Vaillant, Villejuif 94805, France.