Development of a Prognostic Biomarker Score for Nivolumab in Relapsed/Refractory Disease

2021 Year in Review - Renal-Cell Carcinoma - Renal-Cell Carcinoma

Nivolumab is an immune checkpoint inhibitor and is a standard-of-care treatment option for patients with advanced renal-cell carcinoma (RCC) who have disease progression on a first-line tyrosine kinase inhibitor. However, some patients do not experience long-term benefit with immunotherapy, and experts have suggested that the identification of biomarkers could determine which patients will benefit most from these therapies.1

In this multicenter retrospective study, clinical data and laboratory parameters from patients with advanced RCC receiving nivolumab were collected to develop a clinical prognostic score. Statistical methods were used to determine cutoffs for several inflammatory indices from baseline blood samples obtained before nivolumab initiation. Inflammatory measures included neutrophil-to-lymphocyte ratio (NLR), derived NLR, lymphocyte-to-monocyte ratio, platelet-to-lymphocyte ratio, systemic immune-inflammation index, and systemic inflammation response index. Overall survival (OS) from the time of nivolumab initiation was the primary end point. Progression-free survival, overall response rate, disease control rate, and duration of response were secondary end points.1

The study included 571 patients with RCC, of whom 70% were male with a median age of 61 years. Most patients had clear-cell histology (84%) and had received a previous nephrectomy (88%). After a median follow-up of 16.3 months, the median OS was 29.5 months, and the median progression-free survival was 7.3 months. Overall response rate was 31%, and disease control rate was 62%, with a median duration of response of 29.9 months.1

All the inflammatory indices were significantly associated with OS. Worse OS was predicted by higher NLR, derived NLR, platelet-to-lymphocyte ratio, systemic immune-inflammation index, and systemic inflammation response index (P <.001), whereas longer OS was predicted by higher lymphocyte-to-monocyte ratio (P = .009). For the clinical parameters, only poor- and intermediate-risk International Metastatic RCC Database Consortium prognostic score (P <.001) and the presence of bone metastases (P = .002) significantly affected OS.1

The Meet-URO prognostic score was developed and internally validated using the most strongly predictive values: NLR ≥3.2 (2 points), International Metastatic RCC Database Consortium prognostic score (intermediate risk, 3 points; poor risk, 6 points), and the presence of bone metastases (1 point). Median OS was 3.2 months for those with 9 points, 10.3 months for those with 6 to 8 points, 22.4 months for those with 4 or 5 points, 43.9 months for those with 2 or 3 points, and not reached for those with 0 or 1 point.1

The researchers concluded that the Meet-URO score can accurately stratify patients with metastatic RCC who are candidates for nivolumab therapy, providing “an easily and widely-applicable tool for clinical practice at no additional costs.”1 The Meet-URO score is available in an online calculator tool at https://proviso.shinyapps.io/Meet-URO15_score/.

Reference

  1. Rebuzzi SE, Signori A, Banna GL, et al. Inflammatory indices and clinical factors in metastatic renal cell carcinoma patients treated with nivolumab: the development of a novel prognostic score (Meet-URO 15 study). Ther Adv Med Oncol. 2021;13:17588359211019642. Erratum in: Ther Adv Med Oncol. 2021;13:17588359211036552.
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