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Marc Machaalani, MD, discusses retrospective findings from a multi-platform analysis evaluating circulating KIM-1 as a biomarker in metastatic RCC.
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"We do have really compelling and robust data that [are] retrospective in nature, supporting the use of KIM-1 as a biomarker across the disease stages. However, eventually, prospective validation will be very important in order to support these findings to make it through into clinical practice."
Marc Machaalani, MD, a postdoctoral research fellow at Dana-Farber Cancer Institute, discussed retrospective findings from a multi-platform analysis evaluating the potential of role of circulating kidney injury molecule-1 (KIM-1) as a biomarker in patients with metastatic renal cell carcinoma (RCC).
In this integrative study, investigators analyzed retrospective data across multiple platforms—including clinical, genomic, transcriptomic, and immunopathologic datasets—to characterize circulating KIM-1 and its potential association with clinical outcomes in metastatic RCC. KIM-1 is a transmembrane glycoprotein implicated in renal tubular injury and may reflect underlying tumor biology and immune modulation.
To conduct this analysis, circulating levels of KIM-1 were quantified in patients with RCC treated during the phase 3 JAVELIN Renal 101 trial (NCT02684006), using a plasma-based electrochemiluminescence assay. Plasma samples were collected at two key time points: at baseline (cycle 1, day 1) and again at week 12 (cycle 3, day 1). This serial sampling approach enabled investigators to evaluate both baseline KIM-1 expression and dynamic changes over the early course of systemic therapy; the analysis included patients treated with avelumab (Bavencio) plus axitinib (Inlyta) and those given sunitinib (Sutent).
Data from the analysis demonstrated that elevated circulating KIM-1 levels were associated with poorer clinical outcomes. The investigators further evaluated transcriptomic data to identify molecular subgroups with distinct immune signatures. Higher KIM-1 expression correlated with more immunosuppressive tumor microenvironments and higher tumor burden, and it was associated with genomic alterations known to confer aggressive disease phenotypes.
Machaalani emphasized that although these retrospective data are compelling, prospective validation will be critical to determine the predictive and prognostic utility of circulating KIM-1 in metastatic RCC. If validated, KIM-1 could serve as a noninvasive biomarker to help inform treatment decisions, stratify risk, and guide therapeutic selection in patients with advanced RCC.
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