Dr Albigès on the Efficacy of Cabozantinib in Pretreated RCC

Laurence Albigès, MD, PhD, medical oncologist, head, Genitourinary Unit, Department of MedicalOncology, Gustave Roussy Institute, France, discusses on the safety and efficacy of cabozantinib (Cabometyx) in patients with unresectable, locally advanced or metastatic renal cell carcinoma (RCC) with a clear cell component.

The phase 2 multicenter, open-label CaboPoint trial (NCT03945773) evaluated the activity and safety of cabozantinib in patients with unresectable, locally advanced or metastatic clear cell RCC whose disease progressed following treatment with first-line immune checkpoint inhibitor–based therapies. Cohort A consisted of patients who experienced failure on an immune checkpoint inhibitor doublet of nivolumab (Opdivo) plus ipilimumab (Yervoy), and cohort B included patients who had progressed on a VEGF TKI plus immune checkpoint inhibitor combination.

Cabozantinib elicited an overall response rate (ORR) of 29.5% (95% CI, 20.3%-40.2%) across both cohorts, including an ORR of 31.7% (20.3%-45.0%) in cohort A (n = 60) and an ORR of 25.0% (95% CI, 10.7%-44.9%) in cohort B (n = 28). In cohort A, among patients evaluable for best overall response (n = 57), the partial response (PR) rate was 33.3% in cohort A. In cohort B (n = 25), the PR rate was 24.0%, and 1 patient (4.0%) had a complete response. The vast majority of those patients had intermediate-risk disease per International mRCC Database Consortium (IMDC), Albigès says. Notably, among 10 patients who were IMDC intermediate risk at the start of second-line therapy with cabozantinib following nivolumab plus ipilimumab, the ORR was 40%, Albigès notes.

The safety profile within the study was consistent with previous reports, Albigès continues. Based on previous safety data observed in CaboPoint, no new safety signals were reported, and cabozantinib is a potent VGF-TKI that investigators have learned to manage, Albigès notes. In this study, patients were treated at the full dose of 60 mg per day, but in case of toxicity, investigators could reduce the dosing, Albigès concludes.