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


Year:

Session type:

Yoshihiko Tomita1, Anand Sharma2, Robert Motzer3, Toni Choueiri1, Brian Rini4, Hideaki Miyake1, Hirotsugu Uemura1, Laurence Albiges1, Yosuke Fujii1, Yoshiko Umeyama1, Jing Wang5, Mariangela Mariani1, Manuela Schmidinger1
1Other, 2Mount Vernon Cancer Centre, 3Memorial Sloan-Kettering Cancer Center, 4Vanderbilt-Ingram Cancer Center, 5Pfizer

Abstract

Background

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).

Method

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.

Results

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.

 

<65y

<65y

≥65 to <75y

≥65 to <75y

≥75y

≥75y

 

A+Ax(n=271)

S(n=275)

A+Ax(n=138)

S(n=128)

A+Ax(n=33)

S(n=41)

mPFS (95%CI), mo

11.6(8.4-19.4)

6.9(5.6-8.4)

13.8(11.1-18.0)

11.0(7.8-16.6)

13.8(7.0-NE)

9.8(4.3-NE)

Unstratified HR (95%CI)

0.63(0.501-0.786)

 

0.88(0.627-1.231)

 

0.76(0.378-1.511)

 

mOS (95%CI), mo

NE(NE-NE)

28.6(25.5-NE)

30.0(30.0, NE)

NE(NE-NE)

25.3(19.9-NE)

NE(19.4-NE)

Unstratified HR (95%CI)

0.74(0.541-1.022)

 

0.89(0.546, 1.467)

 

0.87(0.359-2.106)

 

ORR (95%CI), %

49.4(43.3-55.6)

27.3(22.1-32.9)

60.9(52.2-69.1)

28.9(21.2-37.6)

42.4(25.5-60.8)

22.0(10.6-37.6)

Conclusion

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.

Impact statement

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.