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Overall survival data for the ipilimumab-nivolumab combination versus sunitinib from the phase 3 CheckMate-214 clinical trial have been published online in the New England Journal of Medicine.
Patients with intermediate-risk or poor-risk clear cell renal cell carcinoma (RCC) respond better and survive longer with first-line treatment with the ipilimumab-nivolumab combination than with standard sunitinib treatment.
Overall survival rates at 18 months were 75% vs 60% in favour of the ipilimumab-nivolumab combination. The risk for death was 37% lower for the combination compared with sunitinib. A significantly higher proportion of patients responded to the combination therapy: 42% of intermediate- or poor-risk RCC patients had an objective response with the combination versus 27% with sunitinib, and 9% of patients had a complete response with the combination vs 1% with sunitinib. Median progression-free survival (PFS) was longer with the combination, but this finding was not significant: 11.6 vs 8.4 months. The combination group also reported greater quality of life.
When overall survival data were analysed for all patients in the study (including favourable-risk patients) researchers found an 18-month overall survival rate of 78% for the ipilimumab-nivolumab combination versus 68% with sunitinib alone. This difference in overall survival rate was significant.
“This trial has produced practice-changing results in kidney cancer and represents another important step in the clinical trials program at MSK [Memorial Sloan Kettering Cancer Centre]. We believe the results of this trial will now make this combination the standard of care in advanced metastatic kidney cancer,” said Dr Motzer, lead investigator at MSK.
In England and Wales, the National Institute for Health and Care Excellence (NICE) is currently appraising the use of the ipilimumab-nivolumab combination for previously untreated patients with metastatic RCC. The appraisal committee meeting is taking place on 10th May 2018, and NICE guidance is expected to be published in October 2018. We will keep you updated on the progress of this appraisal.