Dr. Albigès on the CaboPoint Trial in Advanced RCC

Laurence Albigès, MD, PhD, medical oncologist, head, Genitourinary Unit, Department of MedicalOncology, Gustave Roussy Institute, France, discusses the main objective and trial design of the phase 2 CaboPoint study (NCT03945773) in renal cell carcinoma (RCC), as well as key efficacy and safety data reported in an interim analysis of this study.

The current standard of care (SOC) in the first-line setting of clear cell RCC is treatment with an immune checkpoint inhibitor (ICI) doublet, or an ICI in combination with a VEGF TKI, Albigès begins. Although the use of ICI combination regimens in this setting is well-supported, there is a lack of prospective data on the optimal second-line treatment approach for patients who have failed on first-line combinations, Albigès explains.

To address this question, the multicenter, open-label CaboPoint trial evaluated the activity and safety of cabozantinib (Cabometyx) in adults with unresectable, locally advanced, or metastatic clear cell RCC who experienced disease progression after receiving first-line immune checkpoint inhibitor (ICI)-based therapies, Albigès says. The study involved two main cohorts. Cohort A consisted of patients who experienced failure on an ICI doublet of nivolumab (Opdivo) plus ipilimumab (Yervoy), and cohort B involved patients who had progressed on a VEGF TKI plus ICI combination.

A planned interim analysis was conducted in the first 88 patients to complete 3 months of treatment in cohort A. Results from the analysis showed that cabozantinib elicited an overall response rate (ORR) of 29.5% across both cohorts, with a partial response (PR) rate of 33.3% in cohort A and 24.0% in cohort B, Albigès states. No new safety signals were observed with the regimen, and its adverse effect (AE) profile is consistent with previously observed data. 

Notably, most patients in this analysis had intermediate risk per International mRCC Database Consortium (IMDC) at the start of second-line treatment. These patients who had previously been treated with the ICI doublet experienced a PR, Albigès concludes. Ultimately, cabozantinib demonstrated encouraging preliminary activity in patients with advanced RCC regardless of first-line treatment regimen.

Editor’s Note: Dr. Albigès reports serving as a consultant or in an advisory role for Astellas Pharma, Bristol Myers Squibb, Eisai, Ipsen, Janssen, MSD, Pfizer, and Roche.