Nivolumab-ipilimumab fails to show DFS benefit for certain patients with kidney cancer
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Part A of a phase 3 trial assessing adjuvant nivolumab and ipilimumab for certain patients with renal cell carcinoma failed to meet the primary endpoint of DFS, according to topline data released by the agents’ manufacturer.
CheckMate -914 includes patients with localized disease who underwent radical or partial nephrectomy and have a moderate or high risk for relapse.
DFS assessed by blinded independent central review served as the primary endpoint of both part A, which compared nivolumab (Opdivo, Bristol Myers Squibb) plus ipilimumab (Yervoy, Bristol Myers Squibb) against placebo, and part B, which is evaluating nivolumab alone vs. placebo. Secondary endpoints included OS and incidence of adverse events.
Although the combination missed the primary endpoint in part A of the trial, it exhibited a safety profile consistent with previous studies in solid tumors, according to a press release from Bristol Myers Squibb.
“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, MD, MSCE, vice president and development program lead for genitourinary cancers at Bristol Myers Squibb, said in the press release. “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.”
Bristol Myers Squibb will complete a full evaluation of available data from part A and will work with investigators to present the results to the scientific community, according to the press release. Part B of the trial continues.
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