Dr Albigès on the Predictive and Prognostic Utility of KIM-1 in High-Risk RCC

Laurence Albigès, MD, PhD, medical oncologist, head, Department of Oncology, Institut Gustave Roussy, Paris, discusses the potential predictive and prognostic value of circulating kidney injury molecule-1 (KIM-1) in patients with renal cell carcinoma (RCC), as well as ongoing efforts to validate this biomarker.

In the phase 3 IMmotion010 trial (NCT03024996), patients with RCC at a high risk of disease recurrence following resection were treated with adjuvant atezolizumab (Tecentriq). Following the readout of topline findings from the trial, which demonstrated that atezolizumab did not extend disease-free survival (DFS) vs placebo, a biomarker analysis of circulating KIM-1 levels in this clinical trial population was conducted.

Results from the analysis were presented at the 2024 ASCO Annual Meeting, and confirmed that KIM-1 has prognostic value, as patients with high baseline KIM-1 levels in IMmotion010 had a significantly higher risk of recurrence and a poorer prognosis, Albigès explains. Secondly, patients with high KIM-1 levels receiving atezolizumab experienced prolonged DFS compared with those given placebo, indicating that KIM-1 has predictive value for treatment outcomes with immune checkpoint inhibitors, she states. Thirdly, an increase in KIM-1 levels during treatment was associated with worse DFS, indicating its use as a monitoring tool in this setting, Albigès adds.

The analysis shows that circulating KIM-1 may be a noninvasive marker of MRD and disease recurrence and could be used as a monitoring tool in the adjuvant setting, Albigès outlines. KIM-1 has previously been explored as a diagnostic tool, but it is now being evaluated as a prognostic or predictive tool in the adjuvant setting, Albigès says. Recent analyses of KIM-1 levels from the phase 3 CheckMate 914 trial (NCT03138512) similarly highlighted the predictive utility and validity of this circulating biomarker, she states. This study evaluated adjuvant nivolumab (Opdivo) plus ipilimumab (Yervoy) vs placebo, or adjuvant nivolumab monotherapy vs placebo in patients with localized RCC at a high risk of disease recurrence post-nephrectomy, Albigès details.

Prospective validation of this biomarker is needed, and further datasets will be required to confirm these findings, Albigès concludes.