Cabozantinib can produce responses in patients with advanced clear cell renal cell carcinoma (RCC) whose disease progressed after first-line checkpoint inhibitor (CPI)-based therapy, a phase 2 study suggests.

Results from this study, CaboPoint, were presented at the 2023 ASCO Genitourinary Cancers Symposium by Laurence Albiges, MD, PhD, of Gustave Roussy in Villejuif, France.

The trial ( Identifier: NCT03945773) included 88 patients with locally advanced or metastatic clear cell RCC who had received first-line treatment with CPI-based combinations. In cohort A (n=60), first-line treatment consisted of nivolumab plus ipilimumab in all but 1 patient who received nivolumab monotherapy off protocol. In cohort B (n=28), first-line treatment consisted of pembrolizumab plus axitinib (71.4%) or avelumab plus axitinib (28.6%).

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At baseline, the median age was 62.0 years in cohort A and 69.5 years in cohort B. Most patients were men (73.3% and 78.6%, respectively), had metastatic disease (67.8% and 57.1%), and had prior nephrectomy (56.7% and 71.4%).

The objective response rate (ORR) at 3 months was 29.5% in the overall study population, 31.7% in cohort A, and 25.0% in cohort B.

In cohort A, there were no complete responses, the partial response rate was 33.3%, and the rate of stable disease was 50.9%. In cohort B, the complete response rate was 4.0%, the partial response rate was 24.0%, and the rate of stable disease was 52.0%.

In subgroup analyses, the ORR was highest among patients with 1 metastatic site (51.9%), those with intermediate-risk disease in cohort A (40.0%), and those with an ECOG performance status score of 0 (38.0%). The lowest ORR was seen in patients with 3 or more metastatic sites (15.8%).

“CaboPoint is the first prospective study to assess the efficacy of cabozantinib in a pure second-line setting in what is our routine practice, meaning after failure of a doublet regimen,” Dr Albiges said. “Interim analysis demonstrated high response rates. Of course, we’re awaiting further results that will hopefully be presented later this year with the entire study report.”

Disclosures: This research was supported by Ipsen. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Albiges L, Powles T, Sharma A, et al. CaboPoint: Interim results from a phase 2 study of cabozantinib after checkpoint inhibitor therapy in patients with advanced renal cell carcinoma. ASCO GU 2023. February 16-18, 2023. Abstract 606.