Update on CheckMate -914 trial evaluating Opdivo + Yervoy as adjuvant treatment of localized renal cell carcinoma.- BMS
Bristol Myers Squibb announced that Part A of the Phase III 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.
“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. Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -914 clinical trial.
About CheckMate -914 :CheckMate -914 is a Phase III, randomized, double-blind, placebo-controlled trial evaluating Opdivo in combination with Yervoy compared to placebo (Part A), and Opdivo alone compared to placebo (Part B), in patients with localized renal cell carcinoma (RCC) who have undergone surgery to remove part or all of a kidney and who are at moderate to high risk of relapse. Both parts of the study have a primary endpoint of disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR). Key secondary endpoints include overall survival (OS) and incidence of adverse events (AEs). Part B of the study is ongoing.
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