The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature. The company will complete a full evaluation of the available CheckMate -649 data and work with investigators to share the results at an upcoming medical conference, as well as discuss them with health authorities.ĬheckMate -649 is also evaluating the Opdivo plus Yervoy (ipilimumab) combination compared to chemotherapy in patients with gastric cancer, GEJ cancer or esophageal adenocarcinoma. Teclistamab in Relapsed or Refractory Multiple Myeloma Clinical Decisions Screening for Atrial Fibrillation in Asymptomatic Older Adults Perspective Noncompete Agreements The Need for a Refresh. “We look forward to engaging health authorities worldwide with the goal of bringing this immunotherapy-based treatment option to patients as soon as possible.” Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol Myers Squibb. “The results from CheckMate -649, the largest study of gastric and esophageal cancers conducted to date, indicate the potential for Opdivo plus chemotherapy to change practice in the first-line setting and become a new standard of care for certain patients with gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma,” said Ian M. “Immunotherapy helped transform how we care for our patients across different tumor types, and the encouraging results from CheckMate -649 represent a new opportunity to improve survival for patients beyond standard chemotherapy.” ![]() Janjigian, M.D., Principal Investigator, Chief, Gastrointestinal Oncology, Memorial Sloan Kettering Cancer Center. Responses to the current standard chemotherapy in patients are short lived, and less than 6% of patients with metastatic disease survive beyond five years,” said Yelena Y. “There is an urgent need to improve therapeutic options for patients with esophageal and stomach cancer. The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. Opdivo is the first and only PD-1 inhibitor to demonstrate superior OS and PFS in combination with chemotherapy when compared to chemotherapy alone in patients with gastric cancer, GEJ cancer or esophageal adenocarcinoma. The OS benefit was also observed in the all-randomized population. These results represent the first treatment advance in many years for these patients, potentially establishing adjuvant nivolumab as a new standard of care.Bristol Myers Squibb announced that CheckMate -649, a pivotal Phase 3 trial evaluating Opdivo (nivolumab) plus chemotherapy compared to chemotherapy alone as a first-line treatment for metastatic gastric cancer, gastroesophageal junction (GEJ) cancer or esophageal adenocarcinoma, met both primary endpoints of overall survival (OS) at a pre-specified interim analysis and progression-free survival (PFS) at final analysis in patients whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5. Data including DFS rate and an analysis of DFS across pre-specified subgroups will be presented.Īdjuvant nivolumab is the first therapeutic to provide a statistically significant and clinically meaningful improvement in DFS vs placebo and a well-tolerated safety profile in patients with resected EC/GEJC, who have received neoadjuvant CRT. The frequency of serious TRAEs and TRAEs leading to discontinuation were ≤ 9% with nivolumab and 3% with placebo (Table). ![]() ![]() The majority of treatment-related adverse events (TRAEs) were grade 1 or 2. At a pre-specified interim analysis, adjuvant nivolumab showed a statistically significant improvement in DFS vs placebo (HR 0.69 P = 0.0003) median DFS was doubled (22.4 vs 11.0 mo, respectively Table). Approximately 70% of patients had adenocarcinoma and almost 60% had a pathologic lymph node status ≥ypN1 in both groups. Indication : Esophageal Cancer, Gastroesophageal junction cancerħ94 patients were randomized (nivolumab, 532 placebo, 262).
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