![]() The two main types of lung cancer are non-small cell and small cell. Lung cancer is the leading cause of cancer deaths globally. Key secondary endpoints include overall survival (OS), major pathologic response (MPR) and time to death or distant metastases. The primary endpoints of the trial are pathologic complete response (pCR) and event-free survival. For the primary analysis, 358 patients were randomized to receive either Opdivo 360 mg plus histology-based platinum doublet chemotherapy every three weeks for up to three doses, or platinum doublet chemotherapy every three weeks for up to three doses, followed by surgery. To date, Opdivo has shown improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.ĬheckMate -816 is a Phase 3 randomized, open label, multi-center trial evaluating Opdivo plus chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable non-small cell lung cancer. In non-metastatic NSCLC, Bristol Myers Squibb and collaborators are exploring the use of immunotherapy in the neoadjuvant, adjuvant and peri-operative settings, as well as in association with chemoradiation. The CheckMate -816 trial is currently ongoing to assess the other primary endpoint of event-free survival (EFS), to which the company remains blinded, as well as key secondary endpoints. The company will complete a full evaluation of the available CheckMate -816 data, work with investigators to present the results at an upcoming medical conference and discuss potential regulatory options with health authorities. We’re grateful to the patients and investigators who participated in the CheckMate -816 trial.” “In addition, these data add to our growing scientific understanding of the potential of immunotherapy approaches to transform outcomes in earlier stages of different cancer types, when the immune system may be more responsive. “The CheckMate -816 results build on Bristol Myers Squibb’s heritage in the treatment of thoracic cancers, where Opdivo-based regimens have demonstrated superior overall survival in patients with metastatic non-small cell lung cancer and unresectable malignant pleural mesothelioma,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. We look forward to following patients in this trial of nivolumab plus chemotherapy as a new way of treating resectable non-small cell lung cancer, with the potential that an improvement in pathologic complete response will lead to extended event-free survival and, ultimately, overall survival.” “Nivolumab has shown benefit as an adjuvant, or post-surgical, treatment option in other cancer types, and the positive results from CheckMate -816 speak to its potential in the neoadjuvant setting of resectable non-small cell lung cancer. “Up to half of patients who undergo surgery for non-metastatic lung cancer will experience disease recurrence,” said Mark Awad, M.D., Ph.D., clinical director, Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute. The safety profile of Opdivo plus chemotherapy was consistent with previously reported studies in NSCLC. Patients in the experimental arm of the trial received up to three doses of Opdivo plus chemotherapy prior to surgery, a standard number of cycles of therapy in the neoadjuvant setting. CheckMate -816 is the first and only Phase 3 trial to demonstrate a benefit with an immune checkpoint inhibitor in combination with chemotherapy as a neoadjuvant treatment in non-metastatic NSCLC. In the trial, significantly more patients treated with Opdivo (nivolumab) plus chemotherapy before surgery showed no evidence of cancer cells in their resected tissue compared to those treated with chemotherapy alone. Opdivo -based treatments have now shown benefit in four Phase 3 clinical trials in early-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanomaīristol Myers Squibb (NYSE: BMY) today announced that the Phase 3 CheckMate -816 trial met a primary endpoint of pathologic complete response (pCR) in resectable non-small cell lung cancer (NSCLC). ![]() Positive results mark the first time an immune checkpoint inhibitor-based combination has demonstrated superior efficacy versus chemotherapy as neoadjuvant therapy in a Phase 3 trial in resectable non-small cell lung cancer CheckMate - 816 met a primary endpoint of improved pathologic complete response in patients who received Opdivo plus chemotherapy before surgery
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