The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the nivolumab plus cabozantinib combination for the first-line treatment of people with advanced renal cell carcinoma (RCC).
The European Commission will now review the CHMP recommendation and make a final decision in the next few months on whether to approve the combination. If approved, the combination will be licensed for use within the European Union. The Medicines and Healthcare products Regulatory Agency (MHRA) will need to approve the nivolumab/cabozantinib combination before it can be used in the UK.
The recommendation was based on findings from the phase 3 CheckMate-9ER trial. This study showed that in untreated patients with advanced RCC the combination reduced the risk of disease progression or death by 49% compared to sunitinib. The time to when the treatment stopped working and the cancer started growing again (progression-free survival) was 16.6 months with the combination compared to 8.3 months with sunitinib. Overall survival time could not be assessed because the patients have not been followed-up for long enough. However, there was a 40% reduction in the risk of death with the combination.
The number of serious side effects was similar for both the nivolumab/cabozantinib combination and sunitinib. However, liver side effects were more common with the combination. Nineteen percent of patients on the combination required corticosteroids due to immune-related side effects.
The nivolumab/cabozantinib was approved by the FDA in the United States on 22 January 2021 for the first-line treatment of patients with advanced RCC.