Milan, April 20 (beraking latest news Health) – European Commission’s green light for the monoclonal antibody nivolumab, an immunotherapy drug, in combination with cabozantinib for the first-line treatment of adult patients with advanced renal cell carcinoma (Rcc). This was announced by the American Bristol Myers Squibb (Bms), recalling that “there are two nivolumab-based therapies now authorized for the first-line treatment of patients with advanced RCC in the European Union: nivolumab plus ipilimumab in intermediate-risk disease or unfavorable, and nivolumab in combination with cabozantinib, approved regardless of risk category. “
The decision of the European Commission – explains Bms in a note – is based on the results of the phase 3 CheckMate-9ER study, which demonstrated a superior efficacy of nivolumab in combination with cabozantinib compared to sunitinib for the 3 key endpoints: progression, primary endpoint, objective response rate and overall survival. The nivolumab-cabozantinib combination was well tolerated, with a safety profile reflecting the known one of both medicinal products, and a low rate of treatment-related adverse events leading to discontinuation of therapy.
“With this approval, we can now offer patients two different nivolumab-based combinations that have demonstrated significant survival benefits compared to sunitinib – said Dana Walker, vice president, development program lead, genitourinary cancers BMS – Today’s milestone adds to ours. research heritage to develop and make available new treatments for patients with advanced renal cell carcinoma, first with the only option based on two immunotherapies, nivolumab plus ipilimumab, and now with a new regimen that combines immunotherapy with a tyrosine kinase inhibitor. We are ready to collaborate with a large group of European stakeholders to offer nivolumab in combination with cabozantinib to patients who may benefit from this treatment. “
“The nivolumab-cabozantinib combination combines two proven agents in advanced renal cell carcinoma, which together showed superior efficacy for key endpoints and patient subgroups compared to sunitinib in the CheckMate-9ER study,” says Marc-Oliver Grimm, Professor of medicine and urology department head, Jena University Hospital – Additionally, the safety profile of the association was manageable with known protocols, leading to a low rate of treatment-related interruptions. With today’s approval, clinicians across the The European Union will be able to offer patients with advanced CPR an additional combination therapy that can help them achieve early disease control and improve survival outcomes. “
Nivolumab in combination with cabozantinib has been approved against CRC in the European Union with a flexible dosing regimen, i.e. the possibility of using nivolumab 240 mg administered intravenously every 2 weeks, or nivolumab 480 mg administered for intravenously every 4 weeks, in combination with cabozantinib 40 mg administered once daily orally. In addition to the EU, the combination of nivolumab with cabozantinib was approved in January 2021 for the first-line treatment of advanced renal cell carcinoma by the U.S. Food and Drug Administration, and further registration applications are being evaluated by other regulatory agencies around the world. The results of the CheckMate-9ER study were published in the ‘New England Journal of Medicine’ last March.
“With advances in research, patients are living with advanced kidney cancer longer than in the past and therefore it has become increasingly important to consider how treatment affects everyday life,” said Rachel Giles, International Kidney Cancer Coalition. We are pleased to see the approval of a new first-line association for patients with advanced renal cell carcinoma, which has the potential not only to control the cancer but also to maintain their health-related quality of life. ” .