Efficacy of avelumab + axitinib (A + Ax) vs sunitinib (S) by IMDC risk group in advanced renal cell carcinoma (aRCC): extended follow-up results from JAVELIN Renal 101
Session type: E-poster/poster
In the phase 3 JAVELIN Renal 101 trial (NCT02684006), treatment-naive patients with aRCC receiving A+Ax showed improved progression-free survival (PFS) and objective response rate (ORR) across International Metastatic RCC Database Consortium (IMDC) risk groups (favorable, intermediate, and poor) compared with patients receiving S. Here we report updated efficacy results for A+Ax vs S by IMDC risk groups from the third interim analysis.
Patients were randomized 1:1 to receive either A (10 mg/kg intravenously every 2 weeks) plus Ax (5 mg orally twice daily) or S (50 mg orally once daily) for 4 weeks (6-week cycle). Patients were categorized per IMDC risk group into favorable, intermediate, and poor subgroups, and outcomes were assessed for favorable, intermediate, poor, and intermediate + poor. Overall survival (OS) and PFS, ORR, complete response (CR), and duration of response (DoR) per investigator assessment (RECIST v1.1) were assessed.
The study enrolled 886 patients with aRCC. At data cutoff (Apr 2020), median (95% CI) follow-up for OS in the A+Ax was NR (42.2-NE) vs 37.8 (31.4-NE) months with S. The Table shows OS, PFS, ORR, CR, and DOR by IMDC risk group. A+Ax generally showed improved efficacy compared with S across IMDC groups.
Extended follow-up confirms efficacy benefits of A+Ax vs S across IMDC risk groups in patients with aRCC. Patients continue to be followed up for the final OS analysis.
A+Ax provides an efficacy benefit across IMDC risk groups in patients with aRCC.
© 2021 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2021 ASCO Annual Meeting. All rights reserved.