The phase 2 CaboPoint trial is exploring cabozantinib in patients with locally advanced or metastatic renal cell carcinoma who progressed after first-line checkpoint inhibitor–based combination therapy.
Laurence Albiges, MD, PhD, Institut Gustave Roussy, Villejuif, France, discusses preliminary data from the phase 2 CaboPoint trial (NCT03945773), which point to the efficacy of cabozantinib (Cabometyx) in patients with locally advanced or metastatic renal cell carcinoma (RCC) with a clear-cell component who had progressed after first-line treatment with checkpoint inhibitor–based combination therapy.1
Standard of care for renal cell carcinoma is combination therapy in clear cell RCC, meaning either a doublet of immune checkpoint or an immune checkpoint plus a VGF TKI. However, what we don't know is what should be the treatment to be administered when we have a failure after a combination regimen. And usually what we do is have sequential use of VGF TKI that we haven't used in first line.
The CaboPoint study has been developed to address the question of the activity and safety of cabozantinib as a second-line regimen after our first-line combination. So it's a phase 2 non-randomized study with 2 cohorts. The first cohort, cohort A, is for patients who failed a regimen that was IO-IO meaning nivolumab (Opdivo) plus ipilimumab (Yervoy) and cohort B is for patients who had failed a regimen of VGF TKI plus IO.
Overall, about 120 patients have been enrolled. However, what we reported at the 2023 ASCO GU Cancers Symposium was the first interim analysis of the first 88 patients for which we had more than 3 months’ follow-up.
The primary objective of this study is response rate. And so here in this interim analysis, we are reporting a response rate that is about 30% overall, with a split of 32% in patients who failed prior IO-IO (cohort A) and 25% in patients who failed prior VGF TKI plus IO (cohort B).
Transcript has been edited for clarity.
1. 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. J Clin Oncol. 2023;41(suppl 6):606. doi:10.1200/JCO.2023.41.6_suppl.606