CheckMate -577 trial for Opdivo meets primary endpoint of disease-free survival
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. The OS benefit was also observed in the all-randomized population. 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 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.
“There is an urgent need to improve therapeutic options for patients with esophageal and stomach cancer. 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. Janjigian, M.D., Principal Investigator, Chief, Gastrointestinal Oncology, Memorial Sloan Kettering Cancer Center. “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.”
“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. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol Myers Squibb. “We look forward to engaging health authorities worldwide with the goal of bringing this immunotherapy-based treatment option to patients as soon as possible.”
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.
CheckMate -649 is also evaluating the Opdivo plus Yervoy (ipilimumab) combination compared to chemotherapy in patients with gastric cancer, GEJ cancer or esophageal adenocarcinoma. The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature.