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Clinical Trial
. 2022 Feb 15;28(4):738-747.
doi: 10.1158/1078-0432.CCR-21-1688.

Association of Neutrophil-to-Lymphocyte Ratio with Efficacy of First-Line Avelumab plus Axitinib vs. Sunitinib in Patients with Advanced Renal Cell Carcinoma Enrolled in the Phase 3 JAVELIN Renal 101 Trial

Mehmet A Bilen  1 , Brian I Rini  2 , Martin H Voss  3 , James Larkin  4 , John B A G Haanen  5 , Laurence Albiges  6 , Lance C Pagliaro  7 , Eric G Voog  8 , Elaine T Lam  9 , Nikolay Kislov  10 , Bradley A McGregor  11 , Aly-Khan A Lalani  12 , Bo Huang  13 , Alessandra di Pietro  14 , Stan Krulewicz  15 , Paul B Robbins  16 , Toni K Choueiri  11
Affiliations
Clinical Trial

Association of Neutrophil-to-Lymphocyte Ratio with Efficacy of First-Line Avelumab plus Axitinib vs. Sunitinib in Patients with Advanced Renal Cell Carcinoma Enrolled in the Phase 3 JAVELIN Renal 101 Trial

Mehmet A Bilen et al. Clin Cancer Res. .

Abstract

Purpose: To evaluate the association between neutrophil-to-lymphocyte ratio (NLR) and efficacy of avelumab plus axitinib or sunitinib.

Experimental design: Adult patients with untreated advanced renal cell carcinoma (RCC) with a clear-cell component, ≥1 measurable lesions, Eastern Cooperative Oncology Group performance status of 0 or 1, fresh or archival tumor specimen, and adequate renal, cardiac, and hepatic function were included. Retrospective analyses of the association between baseline NLR and progression-free survival (PFS) and overall survival (OS) in the avelumab plus axitinib or sunitinib arms were performed using the first interim analysis of the phase 3 JAVELIN Renal 101 trial (NCT02684006). Multivariate Cox regression analyses of PFS and OS were conducted. Translational data were assessed to elucidate the underlying biology associated with differences in NLR.

Results: Patients with below-median NLR had longer observed PFS with avelumab plus axitinib [stratified HR, 0.85; 95% confidence interval (CI), 0.634-1.153] or sunitinib (HR, 0.56; 95% CI, 0.415-0.745). In the avelumab plus axitinib or sunitinib arms, respectively, median PFS was 13.8 and 11.2 months in patients with below-median NLR, and 13.3 and 5.6 months in patients with median-or-higher NLR. Below-median NLR was also associated with longer observed OS in the avelumab plus axitinib (HR, 0.51; 95% CI, 0.300-0.871) and sunitinib arms (HR, 0.30; 95% CI, 0.174-0.511). Tumor analyses showed an association between NLR and key biological characteristics, suggesting a role of NLR in underlying mechanisms influencing clinical outcome.

Conclusions: Current data support NLR as a prognostic biomarker in patients with advanced RCC receiving avelumab plus axitinib or sunitinib.

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Figures

Figure 1. PFS per BICR according to NLR in the avelumab plus axitinib arm (A) and sunitinib arm (B) and in patients with a median-or-higher NLR (C). OS according to NLR in the avelumab plus axitinib arm (D) and sunitinib arm (E) and in patients with a median-or-higher NLR (F).
Figure 1.
PFS per BICR according to NLR in the avelumab plus axitinib arm (A) and sunitinib arm (B) and in patients with a median-or-higher NLR (C). OS according to NLR in the avelumab plus axitinib arm (D) and sunitinib arm (E) and in patients with a median-or-higher NLR (F).
Figure 2. Response to avelumab plus axitinib or sunitinib dichotomized by NLR. aIncludes patients with non-complete response/non-progressive disease (n = 4; 1.8%).
Figure 2.
Response to avelumab plus axitinib or sunitinib dichotomized by NLR. aIncludes patients with non-complete response/non-progressive disease (n = 4; 1.8%).
See this image and copyright information in PMC

Comment in

  • Clin Cancer Res. 28:569.
  • Clin Cancer Res. 28:569.

References

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