Bristol Myers Squibb Provides an Update on Kidney Cancer Treatment

On July 29, Bristol Myers Squibb released findings from Part A of their Phase 3 trial. The findings showed that Opdivo (nivolumab) plus Yervoy (ipilimumab) failed to meet the expected endpoints of disease-free survival (DFS) for patients with a certain type of kidney cancer.

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Renal Cell Carcinoma and its Expected Treatments

Localized renal cell carcinoma (RCC) is the most common kidney cancer; each year, there are 431,000 new cases and 179,000 deaths worldwide. This cancer occurs in the lining of the small filtering tubes of the kidney. It is possible for this kind of kidney cancer to appear in one or both kidneys simultaneously. From there, cancer cells can easily spread to other body parts or organs through the bloodstream. Something going wrong with the genes of the kidney is likely the cause.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that uses the body’s immune system to generate an anti-tumor response. The first PD-1 inhibitor to receive regulatory approval globally, over 65 countries have given it approval. Over the years and across multiple clinical trials, Opdivo has treated over 35,000 patients. 

Yervoy human monoclonal antibody binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), inhibiting T-cell activity. Yervoy binds to CTLA-4, which boosts the activation of tumor-infiltrating T-cells. This increase in T-cell response includes an anti-tumor immune response.

What the Findings of the Clinical Trial Means

CheckMate -914 is a randomized, double-blind, placebo-controlled Phase 3 trial that contains two parts. Part A examines the efficacy of Opdivo when combined with Yervoy compared to a placebo, while Part B evaluates Opdivo alone. The patients of this trial were those diagnosed with RCC who have undergone full or partial kidney removal and are at moderate to high risk of relapse. 

The Blinded Independent Central Review (BICR) assessed that the findings from Part A of the study showed that the combination of Opdivo and Yervoy did not meet the endpoints of DFS that Bristol expected. These findings consistently match previous studies of the treatment combination in kidney cancer. 

Despite this, Dana Walker, M.D., M.S.C.E., vice president and development program lead of genitourinary cancers at 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.”

Part B of the trial has yet to conclude its findings. Opdivo might still prove to be an effective treatment for this kind of kidney cancer. 

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Author

Max Heirich