Both the Phase3 Opdivo clinical trials, dubbed CheckMate -577, and CheckMate -649, have reached their primary end-points
Opdivo shows positive results in two Phase 3 clinical trials. (Credit: Chokniti Khongchum from Pixabay.)
Bristol Myers Squibb has unveiled positive results from two different Phase 3 clinical trials, evaluating its PD-1 immune checkpoint inhibitor Opdivo (nivolumab).
Opdivo has been designed to harness the body’s own immune system to fight cancer, and help restore the body’s anti-tumour immune response. The drug has been evaluated in various clinical trials, against different types of tumours.
CheckMate -577 met primary endpoint of disease-free survival (DFS)
The first Phase 3 clinical trial, dubbed CheckMate -577 has evaluated Opdivo as adjuvant therapy for resected oesophageal or gastroesophageal junction cancer (GEJ). The trial has reached the primary endpoint of disease-free survival (DFS) at a prespecified interim analysis.
The clinical study demonstrated that treatment with Opdivo after neoadjuvant chemoradiation therapy (CRT) and complete surgical resection has improved the primary endpoint of DFS than placebo. Opdivo showed a safety profile consistent with previously reported studies.
Bristol Myers Squibb gastrointestinal cancers development lead Ian Waxman said: “Opdivo is the first and only therapy to improve disease-free survival, along with a manageable safety profile, for patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and surgery.
“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.”
CheckMate -649 studied Opdivo plus chemotherapy for metastatic gastric and GEJ cancers
The second Phase 3 clinical trial CheckMate -649 has evaluated Opdivo in combination with chemotherapy as a first-line treatment for metastatic gastric cancer, GEJ cancer or esophageal adenocarcinoma, compared to chemotherapy alone.
The trial has reached primary endpoints including overall survival (OS) at interim analysis and progression-free survival (PFS) at the final analysis, both in patients whose tumours express PD-L1 with a combined positive score (CPS) greater than or equal to five.
In the clinical trial, Opdivo and chemotherapy showed safety profiles similar to the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers.
Waxman added: “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.”