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

Abstract

<div class="section"> <a class="named-anchor" id="S1"> <!-- named anchor --> </a> <h5 class="section-title" id="d888884e403">Background:</h5> <p id="P2">The phase 3 JAVELIN Renal 101 trial ( <a data-untrusted="" href="https://clinicaltrials.gov/ct2/show/NCT02684006" id="d888884e407" target="xrefwindow">NCT02684006</a>) 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. </p> </div><div class="section"> <a class="named-anchor" id="S2"> <!-- named anchor --> </a> <h5 class="section-title" id="d888884e411">Patients and methods:</h5> <p id="P3">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. </p> </div><div class="section"> <a class="named-anchor" id="S3"> <!-- named anchor --> </a> <h5 class="section-title" id="d888884e416">Results:</h5> <p id="P4">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 <i>P</i> &lt; 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 <i>P</i> &lt; 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 <i>P</i> = 0.1301; overall population: HR 0.796 (95% CI 0.616–1.027); one-sided <i>P</i> = 0.0392]. </p> </div><div class="section"> <a class="named-anchor" id="S4"> <!-- named anchor --> </a> <h5 class="section-title" id="d888884e433">Conclusion:</h5> <p id="P5">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. </p> </div><div class="section"> <a class="named-anchor" id="S14"> <!-- named anchor --> </a> <h5 class="section-title" id="d888884e438">Clinical Trial number:</h5> <p id="P6"> <a data-untrusted="" href="https://clinicaltrials.gov/ct2/show/NCT02684006" id="d888884e441" target="xrefwindow">NCT02684006</a>. </p> </div>