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Findings from an expanded access programme giving 389 metastatic renal cell carcinoma (RCC) patients access to nivolumab have been published in the journal, Renal Cell Carcinoma. Of the patients on the programme, 32% were at least 70 years of age and 18% were at least 75 years of age.
The phase III CheckMate 025 trial was used to gain approval for nivolumab as a second-line treatment for patients with metastatic RCC who had failed treatment with a vascular endothelial growth factor (VEGF) inhibitor. However, older patients were under-represented in this trial, and little is known about the activity of nivolumab in this group of patients. The expanded access programme was designed to provide nivolumab to older patients with metastatic RCC.
The safety and efficacy data from the subgroup of older patients were similar to that reported for the expanded access programme overall and the CheckMate 025 trial.
These findings suggest that nivolumab is safe and effective in older patients with pretreated metastatic RCC.