![]() ![]() 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. To date, the Opdivo clinical development program has treated more than 35,000 patients. 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. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. 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. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines, like I-O, a reality for patients. Our researchers are developing a diverse, purposefully built pipeline designed to target different immune system pathways and address the complex and specific interactions between the tumor, its microenvironment and the immune system. Through a unique multidisciplinary approach powered by translational science, we harness our deep scientific experience in oncology and Immuno-Oncology (I-O) research to identify novel treatments tailored to individual patient needs. The focus of our research is to increase quality, long-term survival for patients and make cure a possibility. For patients diagnosed with metastatic lung cancer, the five-year survival rate is approximately 5%.īristol-Myers Squibb: Advancing Oncology ResearchĪt Bristol-Myers Squibb, patients are at the center of everything we do. Survival rates vary depending on the stage and type of the cancer when diagnosed. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer and accounts for up to 85% of diagnoses. The two main types of lung cancer are non-small cell and small cell. Lung cancer is the leading cause of cancer deaths globally. Secondary endpoints included progression-free survival (PFS), overall response rate (ORR), and efficacy measures according to biomarkers. The primary endpoint of the trial was OS in the intent to treat population. Patients in the control arm were treated with up to four cycles of chemotherapy and optional pemetrexed maintenance (if eligible) until disease progression or toxicity. Patients in the experimental arm were treated for up to two years or until disease progression or unacceptable toxicity. The company will complete a full evaluation of the CheckMate -9LA data and looks forward to presenting these results at an upcoming congress and sharing them with regulatory authorities.ĬheckMate -9LA is an open-label, multi-center, randomized phase 3 trial evaluating Opdivo (360 mg Q3W) plus Yervoy (1 mg/kg Q6W) combined with chemotherapy (two cycles) compared to chemotherapy alone (up to four cycles followed by optional pemetrexed maintenance therapy if eligible) as a first-line treatment in patients with advanced NSCLC regardless of PD-L1 expression and histology. ![]() “These results build on the benefit the combination of Opdivo plus Yervoy has previously shown in first-line melanoma, renal cell carcinoma and most recently lung cancer, and may provide a new therapeutic option for patients.” “We are excited by the CheckMate -9LA results, which demonstrate the potential of Opdivo plus low-dose Yervoy to provide a survival benefit to patients with non-small cell lung cancer in the first-line setting when administered concomitantly with a limited course of chemotherapy,” said Fouad Namouni, M.D., head, Oncology Development, Bristol-Myers Squibb. The safety profile of Opdivo plus low-dose Yervoy and two cycles of chemotherapy in CheckMate -9LA was reflective of the known safety profiles of the immunotherapy and chemotherapy components in first-line NSCLC. The comparator in this study was chemotherapy alone for up to four cycles followed by optional maintenance therapy. PRINCETON, N.J.-( BUSINESS WIRE)- Bristol-Myers Squibb Company (NYSE: BMY) today announced that CheckMate -9LA, a pivotal Phase 3 trial evaluating Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) given concomitantly with two cycles of chemotherapy for the first-line treatment of advanced non-small cell lung cancer (NSCLC), met its primary endpoint of superior overall survival (OS) at a pre-specified interim analysis. ![]()
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