There is now an additional cure option for patients with advanced kidney cancer. The European Commission has in fact approved cabozantinib in combination with nivolumab for the first-line treatment of this disease. The approval is based on the results of the CheckMate-9ER clinical trial, presented at the Presidential Symposium of the European Society for Medical Oncology (ESMO) Virtual Congress 2020 and published in the New England Journal of Medicine (NEJM) in early March. In patients who received the combination, median progression-free survival doubled compared to patients who received standard sunitinib therapy: 16.6 months versus 8.3 months. Overall survival also showed statistically significant improvements, with a 40% reduction in the risk of death. Additionally, cabozantinib in combination with nivolumab demonstrated a superior objective response rate, with twice as many patients responding as sunitinib (55.7% vs 27.1%) and 8% vs 4.6% having got a full answer. The combination was also well tolerated and reflects the already known safety profiles of the two drugs.
Additional data from the CheckMate-9ER study were presented in February at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium 2021. These data highlight superior and sustained efficacy of cabozantinib in combination with nivolumab compared to sunitinib for the treatment of first line of advanced kidney cancer, with a median follow-up of 23.5 months, with an improvement in quality of life due to a lower treatment burden, a reduction in the risk of deterioration, and a reduction in disease-related symptoms.
“The combination of nivolumab with cabozantinib combines two drugs proven for advanced renal cell carcinoma that together have shown superior efficacy for all key endpoints and patient subgroups, compared to sunitinib. Furthermore, the safety profile of this association was manageable according to known protocols, leading to a low rate of treatment-related discontinuations, “explains Marc-Oliver Grimm, Professor of Medicine and Head of the Department of Urology at Jena University Hospital ( Thuringia, Germany): “With today’s approval – he concludes – clinicians in the European Union will be able to offer patients with advanced renal cell carcinoma an additional combination therapy that can help them achieve early control of their disease and improve survival outcomes “.