Wenxin (Vincent) Xu, MD, on KIM-1 as a prognostic marker in advanced renal cell carcinoma

A retrospective analysis of the COSMIC-313 trial (NCT03937219) suggests that KIM-1 is prognostic for clinical outcomes and may provide an early biomarker of response in patients with advanced renal cell carcinoma (aRCC).¹ The data were presented at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany.

Lead author Wenxin (Vincent) Xu, MD, recently sat down with Urology Times® to discuss the background and key findings from the study. Xu is an assistant professor of medicine at Harvard Medical School and a medical oncologist at Dana-Farber Cancer Center in Boston, Massachusetts.

The COSMIC-313 trial previously assessed the triplet of cabozantinib, nivolumab, and ipilimumab (C+N+I) vs N+I in first-line aRCC. Plasma KIM-1 was assessed at baseline and 4 weeks following the first dose. Both baseline and week 4 KIM-1 levels were available for 74% of patients (635 of 855).

Overall, data showed that high baseline KIM-1 levels were prognostic for worse clinical outcomes.

Early reduction in KIM-1 levels from baseline to week 4 was linked with improved objective response rate, progression-free survival, and overall survival in patients receiving N+I, but not the triplet regimen. According to the authors, this finding is consistent with data from COSMIC-313. Xu also noted that this indicates that KIM-1 may be a “sensitive biomarker for long-term immunotherapy response.”

Xu also added, “Conversely, if your KIM-1 is going the wrong direction, if it's going up after immunotherapy, these patients are doing less well. And those are patients where we could potentially be doing better with other treatments.”

REFERENCE

1. Xu W, Choueiri TK, Powles TB, et al. Association of circulating kidney injury molecule-1 (KIM-1) levels with clinical outcomes in advanced renal cell carcinoma (aRCC): Retrospective analysis of COSMIC-313. Presented at: European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. Abstract 2594MO. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2025_abstracts/2594MO.html.pdf