The trial of the immunotherapy combination, although approved in other renal cell carcinoma indications, did not meet the endpoint of disease-free survival in patients with localized disease.
The phase 3 CheckMate-914 trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as an adjuvant treatment for patients with localized renal cell carcinoma (RCC) did not meet the primary endpoint of disease-free survival, according to an announcement from Bristol-Myers Squibb. BMS was pursuing the combination to treat patients with localized renal cell carcinoma who have undergone full or partial removal of the kidney and who are at moderate or high risk of relapse.
The safety profile was consistent with previously reported studies of the Opdivo plus Yervoy combination in solid tumors.
“Even with notable progress in the treatment of metastatic renal cell carcinoma, there are still limited treatment options available for patients with localized disease,” Dana Walker, M.D., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb, said in a press release. “We 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: the first-line treatment of patients with previously untreated, intermediate- and poor-risk renal cell carcinoma; with a tyrosine kinase inhibitor for the first-line treatment of patients with previously untreated advanced RCC; and Opdivo for the second-line treatment of patients with previously treated advanced or metastatic renal cell carcinoma.
The company is also investigating Opdivo and Opdivo plus Yervoy in combination with novel agents targeting alternative immunomodulatory molecules and pathways in renal cell carcinoma.