Andrew Hahn, MD, on key findings from the LenCabo trial in metastatic ccRCC

Data from the phase 2 LenCabo trial (NCT05012371) showed that lenvatinib (Lenvima) plus everolimus (Afinitor) reduced the risk of disease progression by 49% compared with cabozantinib (Cabometyx) in patients with metastatic clear cell renal cell carcinoma (ccRCC). The findings were presented at the 2025 European Society for Medical Oncology Congress in Berlin, Germany.¹

In an interview with Urology Times®, presenting author Andrew W. Hahn, MD, detailed the background and key efficacy results from the trial.

“So, the LenCabo study, the goal of this study was to provide the first head-to-head comparison of some of these contemporary agents after PD-1 checkpoint inhibition, specifically comparing lenvatinib plus everolimus vs cabozantinib,” he explained. Hahn is an assistant professor of genitourinary medical oncology at MD Anderson Cancer Center in Houston, Texas.

In total, the study included 86 patients. Overall, Lenvatinib plus everolimus was associated with a statistically significant reduction in the risk of disease progression, with a median progression-free survival (PFS) of 15.7 months vs 10.2 months with cabozantinib.

Further, the objective response rate was 53% in the len/eve cohort vs 39% in the cabozantinib cohort, though this difference did not reach statistically significance. The data for overall survival were immature at the time of data report.

Hahn noted, “There’s a 5% increase in the hazard for death with lenvatinib plus everolimus vs cabozantinib, but again, this is immature and extremely inconclusive.”

REFERENCE

1. LenCabo: A randomized phase II multicenter trial of lenvatinib plus everolimus (len/eve) versus (vs) cabozantinib (cabo) in patients (pts) with metastatic clear cell RCC (ccRCC) that progressed on PD-1 immune checkpoint inhibition (ICI). Presented at: 2025 European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. LBA94