Bristol Myers Squibb (NYSE: BMY) today announced that Part A of the Phase 3 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.
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 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 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.
About Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 431,000 new cases and 179,000 deaths worldwide each year. RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. The five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 14% and five-year disease-free survival (DFS) rates for those with localized disease that can be resected are just over 50%.
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries.
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com