ESMO 2025: Dual targeted therapy shows promise in previously treated advanced kidney cancer patients

(Press-News.org) Study found patients treated with combination of lenvatinib and everolimus lived longer without disease progression First head-to-head study comparing second-line treatments lenvatinib plus everolimus vs. cabozantinib Combination offers option for patients with metastatic clear-cell renal carcinoma (ccRCC) who experience disease progression following first-line immunotherapy BERLIN, OCTOBER 18, 2025 ― Results from a trial led by researchers from The University of Texas MD Anderson Cancer Center showed that a targeted therapy combination improved outcomes for patients with metastatic clear-cell renal carcinoma (ccRCC) – a type of kidney cancer – whose disease progressed following immunotherapy.

 

Data from the LenCabo Phase II trial were presented today by Andrew W. Hahn, M.D., assistant professor of Genitourinary Medical Oncology, at the European Society for Medical Oncology (ESMO) Congress 2025 (Abstract LBA94).

 

What are the key findings of this study?

The randomized study found that patients whose disease got worse after immunotherapy and who were treated with the combination of lenvatinib and everolimus lived longer without disease progression compared to those who received cabozantinib.

“This is the first randomized trial to directly compare these two commonly used second-line treatments,” Hahn said. “These findings offer insights into treatment sequencing and the importance of generating head-to-head data to guide clinical decisions.”

The trial enrolled 90 patients with metastatic or advanced ccRCC or RCC who had previously received one or two treatments, including at least one immunotherapy targeting PD-1 or PD-L1.

Of those treated with lenvatinib and everolimus, 62.5% saw cancer progression in comparison to 76% of those who received cabozantinib. Those treated with lenvatinib plus everolimus had a median progression-free survival (PFS) of 15.7 months compared to 10.2 months for those receiving cabozantinib.

Why are these findings important for patients?

Current first-line treatment for patients with metastatic ccRCC consists of immune checkpoint inhibitors, sometimes combined with targeted therapies. If the cancer stops responding to these treatments, the next treatment options include lenvatinib and everolimus, or cabozantinib.

This trial was designed to evaluate the comparative efficacy of second-line therapies to identify the regimen that provides longer PFS and improved patient outcomes.  

The findings suggest that lenvatinib plus everolimus may offer a more meaningful benefit as second-line treatment and may guide future treatment selection for patients in need.

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This study was supported in part by the National Cancer Institute (P30 CA016672), MD Anderson's Prometheus informatics system, and the Department of Genitourinary Medical Oncology's Eckstein and Alexander Laboratories. For a full list of collaborating authors, disclosures and funding sources, read the data abstract.

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