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Bristol Myers: CheckMate -914 Part A Trial With Opdivo Plus Yervoy Fails To Meet Primary Goal

Biopharmaceutical company Bristol-Myers Squibb Co. (BMY) Friday announced that Part A of the Phase 3 CheckMate -914 trial, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab), as adjuvant treatment of localized renal cell carcinoma or RCC, did not meet the primary endpoint.

In pre-market activity on the NYSE, Bristol Myers shares were losing around 1.4 percent to trade at $73.69.

CheckMate -914 is a Phase 3, 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 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 or DFS as assessed by Blinded Independent Central Review (BICR). Key secondary endpoints include overall survival and incidence of adverse events.

In the Part A trial, the safety profile was consistent with previously reported studies of the Opdivo plus Yervoy combination in solid tumors.

The company noted that Part B of the study is ongoing.

The company said Opdivo and Opdivo-based combinations have demonstrated clinical benefits across several RCC patient populations.

The company is also investigating Opdivo and Opdivo plus Yervoy in combination with novel agents targeting alternative immunomodulatory molecules and pathways in RCC.

Bristol Myers Squibb 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.

Dana Walker, vice president, development program lead, genitourinary cancers, Bristol Myers Squibb, said, "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."

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