Dr Albigès on a Biomarker Analysis of KIM-1 in RCC

Laurence Albigès, MD, PhD, medical oncologist, head, the Department of Oncology, Institut Gustave Roussy, Paris, discusses a biomarker analysis which evaluated the presence of circulating kidney injury molecule-1 (KIM-1) in patients with renal cell carcinoma (RCC) who were enrolled on the phase 3 IMmotion010 trial (NCT03024996).

IMmotion010 is a multicenter, randomized, placebo-controlled, double-blind study which enrolled patients with RCC at a high risk of developing metastasis following nephrectomy; these patients were treated with adjuvant atezolizumab (Tecentriq). Investigators launched this biomarker analysis of the clinical trial to evaluate circulating KIM-1 in this patient population and findings were shared at the 2024 ASCO Annual Meeting.

The biomarker analysis revealed that high baseline levels of KIM-1 correlated with worse disease-free survival (DFS). Moreover, atezolizumab improved DFS in patients with high baseline KIM-1.

This potential biomarker is of interest because it is stable and can be measured in both serum and plasma, making it a strong candidate for a blood biomarker, Albigès begins. This led investigators to an analysis, which involved using high-sensitivity assays on sequential blood samples collected in IMmotion010, she explains. These samples were taken at baseline, cycle 4 day 1, and either at the time of disease recurrence or at treatment discontinuation if there was no recurrence, Albigès reports.

She goes on to stay that several key points were established at study lauch. Firstly, investigators confirmed the prognostic value of KIM-1, as patients with high KIM-1 levels in IMmotion010 had a significantly higher risk of recurrence, marking it as a circulating biomarker, she elucidates. Secondly, KIM-1 also appears to have predictive value; patients receiving atezolizumab had better disease-free survival (DFS) compared with those on placebo, indicating its potential predictive utility, Albigès states. Thirdly, an increase in KIM-1 levels during treatment was associated with worse DFS, suggesting it could be used as a monitoring tool in this setting, Albigès emphasizes.

Lastly, at the time of recurrence, more sensitive assays confirmed that patients who experienced disease recurrence had a two-fold increase in KIM-1 levels, while those who did not relapse did not show high levels of KIM-1, Albigès concludes.