Setback: Bristol Myers drug combo fails to meet main goal in kidney cancer trial
Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults
Princeton: Bristol Myers Squibb has announced that Part A of the Phase 3 CheckMate -914 trial, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as an adjuvant treatment for patients with localized renal cell carcinoma (RCC) who have undergone full or partial removal of the kidney and who are at moderate or high risk of relapse, did not meet the primary endpoint of disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR).The safety profile was consistent with previously reported studies of the Opdivo plus Yervoy combination in solid tumors.
Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 431,000 new cases and 179,000 deaths worldwide each year. RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. The five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 14% and five-year disease-free survival (DFS) rates for those with localized disease that can be resected are just over 50%.
"Even with notable progress in the treatment of metastatic renal cell carcinoma, there are still limited treatment options available for patients with localized disease," said Dana Walker, M.D., M.S.C.E., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb. "Opdivo and Opdivo-based combinations have shown survival benefits in several earlier-stage and advanced cancers, including genitourinary tumors, and we are disappointed that the final analysis of CheckMate -914 Part A did not show this same benefit for the post-surgical treatment of patients with localized RCC. Nonetheless, we are dedicated to continuing research and advancing cancer care for all patients with RCC."
Opdivo and Opdivo-based combinations have demonstrated clinical benefits across several RCC patient populations, including: Opdivo plus Yervoy for the first-line treatment of patients with previously untreated, intermediate- and poor-risk RCC (CheckMate -214 trial), Opdivo and Opdivo plus Yervoy combined with a tyrosine kinase inhibitor for the first-line treatment of patients with previously untreated advanced RCC (CheckMate -9ER and COSMIC-313, respectively) and Opdivo for the second-line treatment of patients with previously treated advanced or metastatic RCC (CheckMate -025). The company is also investigating Opdivo and Opdivo plus Yervoy in combination with novel agents targeting alternative immunomodulatory molecules and pathways in RCC.
"The company will complete a full evaluation of the available CheckMate -914 Part A data and work with investigators to share the results with the scientific community," the company stated.
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