Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
Yoshihiko Tomita , Robert J. Motzer , Toni K. Choueiri , Brian I. Rini , Hideaki Miyake , Mototsugu Oya , Laurence Albiges , Yosuke Fujii , Yoshiko Umeyama , Jing Wang , Alessandra Di Pietro , Manuela Schmidinger
Background: In the phase III JAVELIN Renal 101 trial (NCT02684006), A + Ax demonstrated progression-free survival (PFS) and objective response rate (ORR) benefit across IMDC risk groups (favorable, intermediate, and poor) vs S in patients with previously untreated aRCC. Here we report efficacy of A + Ax vs S by number of IMDC risk factors (0, 1, 2, 3, and 4-6) and target tumor sites (1, 2, 3, and ≥4) at baseline from the second interim analysis of overall survival (OS). Methods: Patients were randomized 1:1 to receive A 10 mg/kg intravenously every 2 wk + Ax 5 mg orally twice daily or S 50 mg orally once daily for 4 wk (6-wk cycle). PFS and ORR per independent central review (RECIST 1.1) and OS were assessed. Results: At data cut-off (Jan 2019), median (m) follow-up for OS and PFS was 19.3 vs 19.2 mo and 16.8 vs 15.2 mo for the A + Ax vs S arm, respectively. The table shows OS, PFS, and ORR by number of IMDC risk factors and target tumor sites at baseline. A + Ax generally demonstrated efficacy benefit vs S across subgroups. Conclusions: With extended follow-up, A + Ax generally demonstrated efficacy benefit vs S across the number of IMDC risk factors and tumor sites at baseline in aRCC. OS was still immature; follow-up for the final analysis is ongoing. Clinical trial information: NCT02684006.
n A + Ax (N=442) | n S (N=444) | mOS (95% CI), mo A + Ax (N=442) | mOS (95% CI), mo S (N=444) | OS Unstratified HR (95% CI) (A + Ax vs S) | mPFS (95% CI), mo A + Ax (N=442) | mPFS (95% CI), mo S (N=444) | PFS Unstratified HR (95% CI) (A + Ax vs S) | ORR (95% CI), % A + Ax (N=442) | ORR (95% CI), % S (N=444) | |
---|---|---|---|---|---|---|---|---|---|---|
No. of IMDC risk factors | ||||||||||
0 | 94 | 96 | NE (NE, NE) | NE (NE, NE) | 0.812 (0.336, 1.960) | 24.0 (20.7, NE) | 16.7 (12.6, NE) | 0.626 (0.397, 0.986) | 67.0 (56.6, 76.4) | 39.6 (29.7, 50.1) |
1 | 157 | 154 | 30.0 (30.0, NE) | 28.6 (26.2, NE) | 0.740 (0.468, 1.171) | 11.1 (8.5, 15.2) | 9.4 (6.9, 11.2) | 0.822 (0.608, 1.111) | 57.3 (49.2, 65.2) | 27.9 (21.0, 35.7) |
2 | 114 | 122 | NE (24.6, NE) | NE (NE, NE) | 1.044 (0.640, 1.705) | 13.8 (7.0, 23.6) | 8.2 (5.2, 9.8) | 0.676 (0.478, 0.954) | 47.4 (37.9, 56.9) | 25.4 (18.0, 34.1) |
3 | 43 | 43 | 25.3 (14.7, NE) | 16.5 (9.9, 23.0) | 0.693 (0.375, 1.279) | 6.7 (2.8, 13.9) | 5.5 (2.8, 6.5) | 0.515 (0.298, 0.889) | 30.2 (17.2, 46.1) | 11.6 (3.9, 25.1) |
4-6 | 29 | 28 | 19.9 (9.6, NE) | 7.8 (4.2, 13.2) | 0.349 (0.169, 0.720) | 5.6 (1.8, 9.0) | 2.7 (1.4, 3.1) | 0.471 (0.251, 0.885) | 34.5 (17.9, 54.3) | 14.3 (4.0, 32.7) |
No. of target tumor sites at baseline | ||||||||||
1 | 178 | 178 | 30.0 (30.0, NE) | NE (28.6, NE) | 0.598 (0.354, 1.010) | 16.1 (11.6, NE) | 9.1 (6.9, 13.8) | 0.670 (0.499, 0.902) | 63.5 (56.0, 70.6) | 30.3 (23.7, 37.7) |
2 | 150 | 152 | NE (24.4, NE) | 27.4 (25.5, NE) | 1.023 (0.672, 1.558) | 12.5 (8.3, 18.0) | 9.5 (6.9, 11.5) | 0.769 (0.567, 1.043) | 50.0 (41.7, 58.3) | 29.6 (22.5, 37.5) |
3 | 69 | 76 | 22.5 (17.7, NE) | 18.9 (13.0, NE) | 0.788 (0.485, 1.282) | 9.7 (5.7, 15.2) | 5.6 (2.8, 6.7) | 0.646 (0.426, 0.980) | 42.0 (30.2, 54.5) | 23.7 (14.7, 34.8) |
≥4 | 35 | 24 | 25.5 (21.2, NE) | 7.8 (5.4, NE) | 0.344 (0.139, 0.799) | 6.8 (2.7, NE) | 2.8 (1.6, 5.8) | 0.516 (0.266, 1.000) | 37.1 (21.5, 55.1) | 12.5 (2.7, 32.4) |
NE, not estimable.
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Abstract Disclosures
2024 ASCO Genitourinary Cancers Symposium
First Author: Viktor Grünwald
2021 ASCO Annual Meeting
First Author: John B. A. G. Haanen
2021 ASCO Annual Meeting
First Author: Yoshihiko Tomita
2023 ASCO Annual Meeting
First Author: Robert J. Motzer