The CheckMate 9ER trial is a phase III trial, open label, that compared nivolumab plus cabozantinib versus sunitinib in patients with treatment naïve metastatic or advanced renal cell carcinoma with clear cell component. It demonstrated a benefit in progression free survival, overall survival and overall response rate of nivolumab plus cabozantinib versus sunitinib with a median follow-up of 18 months. That was maintained with a follow-up of 30 months.
At this conference we presented the relationship of depth of response with the outcomes. We already knew from previous work that the depth of response has a direct relationship with overall survival in advanced renal cell carcinoma. We demonstrated again that patients in the nivolumab plus cabozantinib arm had higher rates of response and that these responses had a direct relationship with progression free survival and overall survival. So, increasingly deeper responses were associated with increasing improvements in PFS and OS.
It’s useful because it gives you an idea of the prognosis of the patient but you can’t change anything. So the patient has a response or not; it’s just giving information about the prognosis and how it’s going to go and how the disease is going to go. But you can’t change anything.
Could this affect other studies in the future?
It could, maybe. And maybe depth of response or the percentage of response should be an endpoint. We know that patients with big shrinkage of the tumour had better prognoses and it’s important information for prognosis.