A trial of Bristol-Myers Squibb’s immune system booster Opdivo has been stopped early after a survival benefit for patients with advanced kidney cancer was demonstrated.
An Independent Data Monitoring Committee put an early stop to the Phase III study after interim analysis concluded that it met its primary endpoint, showing that the PD-1 inhibitor beat Afinitor (everolimus) in improving overall survival.
Opdivo (nivolumab) has already caused quite a stir as a treatment for advanced skin cancer and metastatic non-small cell lung cancer, but according to BMS this is the first time an immuno-oncology agent has shown a survival advantage in advanced renal cell carcinoma (RCC), “a patient group that currently has limited treatment options”.
No mention was made on whether secondary endpoints of the 821-patient CheckMate-025 study - including objective response rate and progression-free survival - were met, but BMS said it plans to present full results at a later stage when evaluation of all the data is complete.
RCC is the most common type of kidney cancer in adults, accounting for more than 100,000 deaths worldwide each year.