CheckMate -9ER trial: Cabozantinib in combination with Nivolumab has shown clinically meaningful efficacy results across all endpoints in untreated advanced renal cell carcinoma
CheckMate -9ER, a pivotal phase III trial evaluating Cabozantinib ( Cabometyx ) in combination with Nivolumab ( Opdivo ) compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma ( RCC ), met its primary endpoint of progression-free survival ( PFS ) at final analysis, as well as the secondary endpoints of overall survival ( OS ) at a pre-specified interim analysis, and objective response rate ( ORR ).
The safety profiles of Cabozantinib and Nivolumab observed in the trial reflect the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in first-line renal cell carcinoma.
CheckMate -9ER is an open-label, randomized, multi-national phase III trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma.
Patients are randomized 1:1 to Nivolumab and Cabozantinib or Sunitinib.
The primary endpoint is progression-free survival. Secondary endpoints include overall survival and objective response rate.
The primary efficacy analysis is comparing the doublet combination versus Sunitinib in all randomized patients.
There are over 400,000 new cases of kidney cancer diagnosed worldwide each year. Of these, renal cell carcinoma is the most common type of kidney cancer, accounting for approximately 90% of cases.
It is twice as common in men, and male patients account for over two thirds of deaths.
If detected in the early stages, the five-year survival rate is high, but for patients with advanced ( aRCC ) or late-stage metastatic RCC, the survival rate is much lower, around 12%, with no identified cure for this disease. ( Xagena )
Source: Ipsen, 2020