Efficacy and safety of avelumab + axitinib (A+Ax) vs sunitinib (S) in elderly patients with advanced renal cell carcinoma (aRCC): extended follow-up results from JAVELIN Renal 101
Session type: E-poster/poster
In the JAVELIN Renal 101 trial (NCT02684006), A+Ax demonstrated significantly longer progression-free survival (PFS) and higher objective response rate (ORR) vs S in patients with previously untreated aRCC. We report, by age group, the efficacy (A+Ax vs S) and safety (A+Ax) from the second interim analysis (IA2) of overall survival (OS).
Patients were randomized 1:1 to receive A 10mg/kg intravenously Q2W +Ax 5mg orally BID or S 50mg orally QD for 4 wk (6-wk cycle). PFS and ORR per independent central review (RECIST 1.1), OS, and safety by age group were assessed.
A total of 271/138/33 and 275/128/41 patients per age group (<65, ≥65 to <75, and ≥75y) were randomized to A+Ax or S. Baseline characteristics (including IMDC groups) were generally well balanced between arms, although in the ≥75y age group, the frequency of patients with intermediate risk was slightly higher in the A+Ax arm, and that of patients with favorable risk was slightly higher in the S arm. Percentages of patients with favorable/intermediate/poor risk in each age group: 19%/61%/19%, 28%/58%/13%, and 12%/76%/12% (A+Ax) vs 20%/63%/16%, 23%/60%/16%, and 24%/61%/15% (S). At IA2 data cut-off (Jan 2019), median follow-up for PFS and OS was 16.8 vs 15.2mo and 19.3 vs 19.2mo (A+Ax vs S). The table shows PFS, OS, and ORR by age group. In the A+Ax arm, the most common treatment-emergent adverse events (TEAEs) were diarrhea (67%/71%/52%), hypertension (52%/51%/58%), fatigue (40%/55%/30%), palmar-plantar erythrodysesthesia (40%/32%/15%), and nausea (36%/41%/24%); grade ≥3 TEAEs and all-grade immune-related AEs were observed in 77%/81%/73% and 46%/48%/36% of patients in each age group.
A+Ax demonstrated favorable efficacy across age groups, including patients aged ≥75y. OS was immature; follow-up for final analysis is ongoing. The safety profile was generally consistent between age groups.
A+Ax is safe and efficacious in elderly patients.
© 2021 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2021 Genitourinary Cancers Symposium. All rights reserved.