On February 15, Bristol-Myers Squibb (BMS) announced the 5-year follow-up data from the Phase III CheckMate-025 study evaluating Opdivo in patients with advanced or metastatic renal cell carcinoma (RCC).
CheckMate -025 is an open-label, randomized Phase III clinical trial designed to evaluate the efficacy and safety of Opdivo compared with everolimus in patients with advanced or metastatic renal cell carcinoma (RCC) who have previously received anti-angiogenic therapy.
After a minimum follow-up of 64 months, 26% of patients treated with Opdivo remained alive, compared to 18% in the everolimus group. Additionally, the objective response rates (ORR) for the Opdivo and everolimus groups were 23% and 4%, respectively, with median durations of response (DoR) of 18.2 and 14 months, respectively.
The safety profile was consistent with previous reports, with the incidence of grade 3/4 adverse events being 21% and 37% in patients treated with Opdivo and everolimus, respectively.
Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, causing more than 140,000 deaths worldwide each year. The incidence of kidney cancer in men is approximately twice that in women, with the highest rates observed in North America and Europe. Globally, the five-year survival rate for patients with metastatic or advanced renal cell carcinoma is 12.1%.