CheckMate -025 trial: 26% of patients treated with Nivolumab are alive at five years in previously treated advanced or metastatic renal cell carcinoma
Five-year follow-up results from the phase 3 CheckMate -025 study continue to demonstrate that treatment with Nivolumab ( Opdivo ) delivers superior overall survival ( OS ) and objective response rates ( ORR ) in patients with previously treated advanced or metastatic renal cell carcinoma ( RCC ) compared to those treated with Everolimus ( Afinitor ).
With an extended minimum follow-up of 64 months, patients treated with Nivolumab continue to demonstrate OS benefit with 26% of patients alive compared to 18% of patients treated with Everolimus.
Additionally, the percentage of patients experiencing an objective response was 23% for Nivolumab versus 4% for Everolimus and the median duration of response ( mDOR ) for Nivolumab was also maintained longer than for Everolimus ( 18.2 months vs. 14 months, respectively ).
The overall safety profile was consistent with that observed in previously reported analyses from CheckMate -025 in patients with renal cell carcinoma.
No new safety signals or drug-related deaths occurred with extended follow-up.
CheckMate -025 is an open-label, randomized phase 3 study of Nivolumab versus Everolimus in patients with previously treated advanced renal cell carcinoma after prior anti-angiogenic therapy.
Patients ( n=803 ) received either Nivolumab ( n=406 ) 3 mg/kg intravenously ( IV ) every two weeks or Everolimus ( n=397 ) 10 mg orally once daily until disease progression or unacceptable toxicity.
The primary endpoint of the study was overall survival. Secondary endpoints included objective response rate, progression-free survival, quality of life and safety.
With a minimum of five years of follow-up, the incidence and type of treatment-related adverse events were consistent with the primary analysis.
Treatment-related grade 3/4 adverse effects were experienced by 21% of patients in the Nivolumab group and 37% in the Everolimus group.
Renal cell carcinoma is the most common type of kidney cancer in adults, accounting for more than 140,000 deaths worldwide each year.
Renal cell carcinoma is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe.
Globally, the five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 12.1%. ( Xagena )
Source: BMS, 2020