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The first results from a phase 2 study (FRACTION-RCC) looking at new immunotherapy combinations in patients with advanced kidney cancer have been published. Patients who had not been previously treated with immunotherapy (immunotherapy-naive patients) were treated with a combination of nivolumab plus a new immunotherapy called relatlimab or nivolumab plus ipilimumab.
Immunotherapy-naive patients were recruited from 32 hospitals in six countries and randomly allocated to be treated with nivolumab plus relatlimab infusion once every 2 weeks or nivolumab plus ipilimumab infusion once every 3 weeks for four doses, followed by nivolumab infusion once every 4 weeks for up to two years.
Thirty (30) patients were treated with nivolumab plus relatlimab and 30 patients were treated with nivolumab plus ipilimumab. Nearly a third of patients (30%) responded to treatment with nivolumab plus relatlimab. The average duration of this response was 33 weeks. At 24 weeks, just over 4 in 10 patients were progression-free, in other words their cancer had not worsened or progressed. The results for the nivolumab plus ipilimumab combination were similar, with one fifth of patients responding to treatment and about half of the patients being progression-free at 24 weeks.
Just over 1 in 10 patients reported serious or life-threatening treatment-related side effects with nivolumab plus relatlimab and a third of patients reported serious or life-threatening treatment-related side effects with nivolumab plus ipilimumab.
Nivolumab plus relatlimab showed anti-tumour activity in immunotherapy-naive patients with advanced kidney cancer and was well tolerated. The findings from this study also support the use of nivolumab plus ipilimumab as an effective combination treatment for immunotherapy-naive patients with advanced kidney cancer.
