8/31/2023 0 Comments Keynote 426 criticism![]() PFS, OS, and DR were estimated using the Kaplan–Meier method, and one-sided P values are reported. The OR rate (ORR) was calculated according to treatment with corresponding exact two-sided 95% CIs using the Clopper–Pearson method. All data reported here are based on the second interim analysis.Įfficacy end points were assessed in all patients who underwent randomization. The second preplanned interim analysis was based on a data cut-off time point when approximately 336 PFS events by BICR occurred in patients with PD-L1+ tumors and the last randomized patient had been followed for ≥12 months after randomization (primary analysis for PFS and second interim analysis for OS). 6 Additional details are in the supplementary Methods, available at Annals of Oncology online. In addition, updated OS, PFS on next-line therapy (PFS2), mean duration of response (DR), and a rank-preserving structural failure time (RPSFT) analysis of OS that accounts for the subsequent use of anti-PD-1 or anti-PD-L1 inhibitors after progression are reported.ĭetails of the statistical analyses were previously described. We report updated PFS results at the preplanned second interim analysis after a minimum follow-up of 13 months in all patients (data cut-off: 28 January 2019). ![]() 6 Based on these data, the US Food and Drug Administration and the European Commission approved the combination for first-line treatment of aRCC. Overall survival (OS) data were immature at the time. 5Īt the first interim analysis of the phase 3 JAVELIN Renal 101 trial (minimum follow-up: 6 months), avelumab plus axitinib demonstrated significantly longer progression-free survival (PFS) than sunitinib in patients with PD-L1+ tumors and in the overall population. 3, 4 Avelumab, a human anti-programmed death ligand 1 (PD-L1) immunoglobulin G1 monoclonal antibody, has shown single-agent activity in aRCC. 1, 2 Axitinib, a VEGFR tyrosine kinase inhibitor, is approved for second-line treatment of aRCC. Antiangiogenic drugs targeting the vascular endothelial growth factor receptor vascular endothelial growth factor receptor (VEGFR) pathway are effective in treating advanced renal cell carcinoma (aRCC).
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