First immunotherapy approved for renal cell cancer

The European Union (EU) has approved the combination of nivolumab plus ipilimumab for the first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC). This is the first approval of immunotherapy for RCC in the EU.

The approval is based on results from the phase 3, randomised, open-label study, CheckMate-214, which was stopped early when an interim analysis showed that the combination demonstrated a significant increase in overall survival, with a 37% decreased risk of death in intermediate- and poor-risk patients compared to sunitinib which is a current standard of care (HR 0.63; 99.8%: 95% CI 0.44–0.89; p<0.0001). The survival benefit was seen regardless of PD-L1 expression level.

The combination also demonstrated a higher objective response rate of 41.6% (CI 36.9–46.5; p<0.0001) versus 26.5% for sunitinib (CI 22.4–31.0) and a complete response rate of 9.4% versus 1.2%. The combination of nivolumab and ipilimumab was better tolerated than sunitinib.

‘Currently, less than 50% of patients with metastatic RCC survive beyond two years, and there is almost no complete remission observed, which underscores the need for new treatments for this disease,’ says Dr Bernard Escudier, former Chairman of the Genitourinary Oncology Committee, Institut Gustave Roussy in France. ‘This approval offers patients a first-line treatment option that has demonstrated a complete response rate of almost 10% and a significant improvement in overall survival with fewer adverse reactions compared to sunitinib.’

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