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GU Cancers 2021 | BREAKPOINT: cabozantinib after first-line ICI in RCC

Giuseppe Procopio, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, gives a summary of the Phase II BREAKPOINT trial (NCT03463681) investigating cabozantinib after first-line immune checkpoint inhibitor (ICI) therapy in patients with advanced or unresectable renal cell carcinoma (RCC). Cabozantinib treatment has demonstrated prolonged survival in previously treated metastatic RCC patients. The primary endpoint of the BREAKPOINT study is progression-free survival (PFS). So far, the study, which has analyzed data from 22 patients, found that 22% of patients achieved a partial response and 5% of patients achieved stable disease. At a median follow-up of 7.2 months, the median PFS was 7.2 months. Thus far, cabozantinib therapy after first-line ICI therapy has demonstrated clinical activity and has been well-tolerated. This interview took place during the 2021 Genitourinary Cancers Symposium.

Transcript (edited for clarity)

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.

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Disclosures

Dr Giuseppe Procopio, MD, has participated in an advisory role for AstraZeneca, Bayer, Ipsen, Janssen, Merckx, MSD Pharmaceuticals, Novartis, Pfizer and BMS.

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