Netherlands Cancer Institute, Amsterdam, Netherlands
John B. A. G. Haanen , James Larkin , Toni K. Choueiri , Laurence Albiges , Brian I. Rini , Michael B. Atkins , Manuela Schmidinger , Konstantin Penkov , Despina Thomaidou , Jing Wang , Mariangela Mariani , Alessandra Di Pietro , Robert J. Motzer
Background: 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 [F], intermediate [I], and poor [P]) 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. Methods: 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 F, I, and P subgroups, and outcomes were assessed for F, I, P, and I + P. Overall survival (OS) and PFS, ORR, complete response (CR), and duration of response (DoR) per investigator assessment (RECIST v1.1) were assessed. Results: 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. Conclusions: Consistent with previously reported results from prior interim analyses, extended follow-up confirms the 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. Clinical trial information: NCT02684006
IMDC risk group | Favorable A + Ax (N = 442) | Favorable S (N = 444) | Intermediate A + Ax (N = 442) | Intermediate S (N = 444) | Poor A + Ax (N = 442) | Poor S (N = 444) | Intermediate + Poor A + Ax (N = 442) | Intermediate + Poor S (N = 444) |
---|---|---|---|---|---|---|---|---|
n | 94 | 96 | 270 | 276 | 73 | 71 | 343 | 347 |
mOS (95% CI), mo HR* (95% CI) | NE (NE-NE) 0.66 (0.356-1.22) | NE (39.8-NE) Ref | 42.2 (33.1-NE) 0.84 (0.649-1.08) | 37.8 (29.6-NE) Ref | 21.3 (14.7-33.1) 0.60 (0.399-0.912) | 11.0 (7.8-16.5) Ref | 40.0 (30.5-NE) 0.79 (0.636-0.98) | 29.5 (24.8-38.0) Ref |
mPFS (95% CI), mo HR* (95% CI) | 20.7 (16.6-26.3) 0.71 (0.490-1.02) | 13.8 (11.1-23.5) Ref | 12.9 (11.1-16.6) 0.71 (0.578-0.866) | 8.4 (7.9-10.1) Ref | 8.7 (5.6-11.1) 0.45 (0.304-0.678) | 4.2 (2.8-5.5) Ref | 11.1 (9.8-14.6) 0.66 (0.550-0.787) | 8.2 (6.9-8.4) Ref |
ORR (95% CI), % | 75.5 (65.6-83.8) | 45.8 (35.6-56.3) | 59.6 (53.5-65.5) | 31.2 (25.7-37.0) | 38.4 (27.2-50.5) | 15.5 (8.0-26.0) | 55.1 (49.7-60.4) | 28 (23.3-33.0) |
CR, n (%) | 9 (9.6) | 5 (5.2) | 11 (4.1) | 8 (2.9) | 1 (1.4) | 1(1.4) | 12 (3.5) | 9 (2.6) |
DoR (95% CI), mo | 22.6 (15.2-31.7) (n = 71) | 20.8 (14.5-24.9) (n = 44) | 19.3 (13.9-22.1) (n = 161) | 12.5 (7.1-16.6) (n = 86) | 18.2 (6.8-NE) (n = 28) | 5.6 (2.5-8.3) (n = 11) | 19.3 (13.9-22.1) (n = 189) | 9.8 (7.0-15.3) (n = 97) |
m, median; mo, months; NE, not estimable; HR, hazard ratio; Ref, reference. * Unstratified.
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Abstract Disclosures
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