Andrew Hahn, MD, on the safety profile for lenvatinib/everolimus vs cabozantinib

The LenCabo trial (NCT05012371), presented at the 2025 European Society for Medical Oncology (ESMO) Congress, in Berlin, Germany, demonstrated that the combination of lenvatinib (Lenvima) plus everolimus (Afinitor) significantly prolonged progression-free survival compared with cabozantinib (Cabometyx) in patients with metastatic clear cell renal cell carcinoma (ccRCC).¹

The combination did show more adverse events compared with cabozantinib, but these differences did not reach statistical significance. In an interview with Urology Times®, presenting author Andrew W. Hahn, MD, compared the safety profiles for each regimen.

In total, the study included 86 patients, of whom 40 received the combination and 46 received cabozantinib. Grade 3/4 adverse events (AEs) were observed in 67.5% of patients in the combination arm vs 50% of patients in the cabozantinib arm (OR, 2.08; 95% CI, 0.86 to 5.02). In total, 20% of patients in the lenvatinib/everolimus arm vs 11% in the cabozantinib arm (OR, 2.05; 95% CI, 0.61 to 6.91).

REFERENCE

1. Hahn AW, Chahoud J, Skelton W, et al. 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. Abstract LBA94. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2025_abstracts/LBA94.html.pdf