Bristol-Myers Squibb reported positive results from two separate Phase III clinical trials, CheckMate -577 and CheckMate -649, evaluating Opdivo for metastatic gastric cancer, gastroesophageal junction (GEJ) cancer or esophageal adenocarcinoma. Both trials met their respective primary endpoints.
CheckMate-577 was a randomized, multi-center, double-blind study evaluating Opdivo as an adjuvant therapy in patients with resected esophageal or GEJ cancer who had received neoadjuvant chemoradiation therapy (CRT) therapy but did not achieve a complete pathological response. Patients were randomized to receive a placebo or Opdivo 240 mg by intravenous infusion every two weeks for 16 weeks, followed by Opdivo 480 mg every four weeks until disease progression or unacceptable toxicity. Patients in the Opdivo treatment arm demonstrated a statistically significant improvement in the primary endpoint of disease-free survival (DFS) compared to placebo in the all-randomized population.
BMS will fully evaluate the available CheckMate -577 data and plans to present the results at an upcoming medical conference, as well as discuss them with health authorities. The CheckMate -577 trial will continue as planned to allow for future analysis of the secondary endpoint of overall survival (OS).
CheckMate-649 is a randomized, multi-center, open-label study evaluating Opdivo plus chemotherapy or the Opdivo plus Yervoy combination compared to chemotherapy alone in patients with previously untreated, non-HER2-positive, advanced or metastatic gastric cancer, GEJ cancer or esophageal adenocarcinoma. Patients in the Opdivo plus chemotherapy arm received Opdivo 360 mg plus capecitabine and oxaliplatin (CapeOX) every three weeks or Opdivo 240 mg plus 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX) every two weeks. Patients in the Opdivo plus Yervoy arm received Opdivo 1 mg/kg plus Yervoy 3 mg/kg every three weeks for four cycles, followed by Opdivo 240 mg every two weeks. Patients in the chemotherapy arm received FOLFOX or CapeOX every two or three weeks, respectively. All patients continued treatment for two years or until disease progression, unacceptable toxicity, or withdrawal of consent. The trial met both primary endpoints of 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.
BMS 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.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response.
Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan, and China.
About Gastric Cancer
Gastric cancer is the fifth most common cancer and the third leading cause of cancer death worldwide. The five-year relative survival rate is 5.5% for patients diagnosed with metastatic disease in the U.S. There are several cancers that can be classified as gastric cancer, including certain types of cancers that form in the GEJ, the area of the digestive tract where the esophagus and stomach connect. While GEJ cancer has a lower prevalence than gastric cancer, it continues to rise. First-line treatment for patients with gastric or GEJ cancer often provides the best chance for efficacy as many patients cannot proceed to subsequent treatments in later settings due to deterioration.
About Esophageal Cancer
Esophageal cancer is the seventh most common cancer and the sixth leading cause of death from cancer worldwide. The five-year relative survival rate is 4.9% or less for patients diagnosed with metastatic disease in the U.S. The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for approximately 85% and 15% of all esophageal cancers, respectively, though esophageal tumor histology can vary by region with the highest rate of esophageal adenocarcinoma occurring in North America (65%). The majority of cases are diagnosed in the advanced setting and impact a patient’s daily life, including their ability to eat and drink.