Odivo (nivolumab) combined with chemotherapy and Odivo combined with ipilimumab in the treatment of patients with advanced unresectable or metastatic esophageal squamous cell carcinoma can bring significant survival benefits

Odivo is the world's first and currently the only PD-1/L1 inhibitor that has been proven to have significant efficacy in the first-line treatment of upper gastrointestinal malignancies (regardless of histological type and tumor location).

According to the CheckMate-648 study, Odivo combined with chemotherapy and Odivo combined with ipilimumab achieved statistically significant overall survival benefits in PD-L1 positive patients and all random populations

On April 8, 2021, Bristol-Myers Squibb (NYSE: BMY) today announced the positive results of its Phase III clinical study CheckMate -648.

In a pre-set interim analysis, Odivo combined with chemotherapy showed statistical differences and clinical benefits in the overall survival (OS) of the primary endpoint tumor PD-L1 positive population and the secondary endpoint OS of all random populations.

The Odivo plus Ipilimumab group also reached the primary and secondary study endpoints, and showed statistically significant and clinically significant overall survival improvement in patients with PD-L1 tumors and all randomized populations.

In this study, the safety of Odivo and Odivo combined with ipilimumab is consistent with the safety previously reported.

"For patients with esophageal cancer whose cancer has spread at the time of diagnosis, the research results of Odivo-based combination therapy are an extremely important development for them, and it is expected to bring them new treatment options in the future.

CheckMate -648 research data is based on CheckMate -649 research data.

Bristol-Myers Squibb will complete the further evaluation of CheckMate-648 research data in the future, and look forward to publishing the results at an academic conference in the near future.

About CheckMate -648

CheckMate -648 is a phase III randomized clinical study designed to evaluate the use of Odivo combined with ipilimumab or Odivo combined with fluorouracil and cisplatin for advanced unresectable compared with chemotherapy alone (fluorouracil + cisplatin) Or the efficacy and safety of patients with metastatic esophageal squamous cell carcinoma.

The primary endpoint of the study was to compare the overall survival (OS) and progression-free survival (PFS) of PD-L1 positive patients with tumors that were evaluated by blinded independent center assessment (BICR) by comparing Odivo-based combination therapy and chemotherapy.

Patients in the Odivo plus Ipilimumab group received Odivo 3 mg/kg (once every 2 weeks) combined with Ipilimumab 1 mg/kg (once every 6 weeks) and continued treatment for up to 24 months Or until the disease progresses or intolerable toxicity occurs.

Patients in the Odivo combined chemotherapy group received Odivo 240 mg (days 1 and 15) combined with fluorouracil 800 mg/m2/day (days 1 to 5, 5 days in total) and cisplatin 80 mg/m2 (Day 1) treatment, every 4 weeks is a course of treatment.

About esophageal cancer

Esophageal cancer is the eighth most common cancer in the world and the sixth leading cause of cancer deaths.