Bristol Myers Squibb has revealed the results from the Phase III CheckMate-649 evaluating Opdivo (nivolumab) plus chemotherapy in first-line metastatic gastric cancer, gastroesophageal junction (GEJ) cancer or oesophageal adenocarcinoma.
In the trial, Opdivo plus chemotherapy met both primary endpoints of overall survival and progression-free survival in patients whose tumours express PD-L1. BMS has not revealed the full data as of yet, but plans to share the results at an upcoming medical conference and discuss them with healthcare regulators.
“The results from CheckMate -649, the largest study of gastric and oesophageal 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 oesophageal adenocarcinoma,” said Ian M. Waxman, development lead, Gastrointestinal Cancers, Bristol Myers Squibb.
BMS also released the topline results from the Phase III CheckMate-577 trial evaluating Opdivo as an adjuvant therapy for patients with resected oesophageal or GEJ cancer.
At a pre-specified interim analysis, the immunotherapy met its primary endpoint of disease-free survival, demonstrating a statistically significant improvement compared to placebo.
“The results from CheckMate -577 are immensely important for physicians and patients, and have the potential to establish Opdivo as a new standard of care. We plan to provide our data to health authorities worldwide with the goal of bringing Opdivo as an adjuvant therapy to these patients with high unmet need,” added Waxman.