BREAKPOINT trial is a multilevel Phase II trial designed to assess the role of cabozantinib after a previous immune checkpoint inhibitor used in first-line in advanced renal cell carcinoma.
This study was designed in order to assess the clinical activity and the safety profile of cabozantinib in a population affected by the advance of the renal cell carcinoma, predominantly with the [inaudible], in the patient receiving their first line with IO/IO or an IO/TKI combination...
BREAKPOINT trial is a multilevel Phase II trial designed to assess the role of cabozantinib after a previous immune checkpoint inhibitor used in first-line in advanced renal cell carcinoma.
This study was designed in order to assess the clinical activity and the safety profile of cabozantinib in a population affected by the advance of the renal cell carcinoma, predominantly with the [inaudible], in the patient receiving their first line with IO/IO or an IO/TKI combination. This represent an unmet medical need for the general community of physicians and investigators in the landscape of the events of the renal cell carcinoma.
So this study was a multicenter trial designed three years ago. And until now, 22 patients were enrolled. And in this study population, the median progression-free survival, that was the primary endpoint, was 7.2 months. And the treatment was safe and the basic model without unexpected toxicity.
And in this clinical trial, grade III-IV adverse events occurred in 22.7% of the patients, and most common adverse events were hand and foot skin reaction, fatigue, mucositis, diarrhea, and hypertension. So, the majority of the patients are able to continue the treatment at the full dose, and some patients required a dose modification.
Of course, this is a mid-term analysis of the clinical trial. Because of the simple science, it will be over 49 patients. And hopefully to complete the accrual in the next month, in order to present an update of this clinical study.
So in summary, a Phase II trial support the clinical activity of cabozantinib after IO/IO or IO/tyrosine kinase inhibitors in second-line events of the renal cell carcinoma.