KIM-1 levels in papillary renal cell carcinoma from the CALYPSO trial
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Authors
Coca Membribes, Sara
Jackson-Spence, Francesca
Suárez, Cristina
Patel, Poulam M.
Larkin, James M. G.
Perez Valderrama, Begona
Rodríguez-Vida, Alejo
Mendez Vidal, Maria Jose
Szabados, Bernadett Emma
Nally, Elizabeth
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2026
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Abstract
Background: Kidney Injury Molecule-1 (KIM-1) has emerged as a promising biomarker in clear cell renal cell carcinoma (RCC), but its role in papillary RCC remains unknown. Methods: Serum KIM-1 concentrations were analyzed in patients with papillary RCC (n=32) and clear cell RCC (n=123) enrolled in a prospective randomized phase II trial evaluating durvalumab plus savolitinib (D+S) for papillary RCC. Associations between KIM-1 and clinicopathologic or molecular features were evaluated. Longitudinal changes in KIM-1 with time were correlated with radiologic response, circulating tumor DNA (ctDNA) status and molecular subgroups. Results: The median KIM1 levels for patients (n=32) with papillary RCC who received D+S was 7835 pg/mL. This was significantly higher than the clear cell RCC cohort (n=123) at baseline (5470 pg/mL, p=0.05). Other comparisons between these cohorts are shown in Table 1. In the papillary cohort, higher baseline KIM-1 levels did not correlate with the IMDC score, PD-L1 or TMB, but were lower in MET-driven tumors compared to non-MET driven (4217 vs 19834 pg/mL, p=0.05). Radiological response was associated with lower baseline KIM-1 levels (3368 vs 14154 pg/mL in non-radiological responders, p=0.025). Sequential KIM-1 results (n=19) showed a 54% decrease in radiological responders vs a 7% decrease in non-radiological responders (59% vs 11% in MET vs non-MET driven tumors). ctDNA positivity correlated with higher KIM-1 concentrations (17448 vs 5226 pg/mL in ctDNA-negative), and the combination of ctDNA positivity and elevated KIM-1 identified patients with poorer outcomes. Conclusions: KIM-1 levels are raised in papillary RCC. They correlated with tumor biology, MET status and response to treatment. Clinical trial information: NCT02819596.
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Journal of Clinical Oncology
Volume
44