OdivoIt is the first and only one in the world that has been proved to be effective in the first-line treatment of malignant tumors of the upper digestive tract (regardless of histological type and tumor location).PD-1/L1Inhibitor
According toCheckMate-648Research，OdivoCombined chemotherapy andOdivoUnionIpimumab在PD-L1Statistically significant overall survival benefits were achieved in positive patients and all random populations.
Shanghai, April 9 / PRNewswire-FirstCall /-- Bristol-Myers Squibb China has released the positive results of the phase III clinical trial CheckMate-648. The purpose of this study is to evaluateOdivo(Navelliu monoclonal antibody) combined with chemotherapy orOdivoUnionIpimumabEfficacy and safety of (ESCC) in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma.
In a predetermined interim analysisOdivoCombination chemotherapy showed statistical differences and clinical benefits in the overall survival (OS) of tumor PD-L1 positive patients at the main end point and the OS of all random populations at secondary endpoints. In addition, (BICR) was evaluated by blind independent centers in tumor PD-L1 positive people.OdivoCombination chemotherapy also showed statistical differences and clinical benefits at the other major study end point, progression-free survival ((PFS)).
OdivoUnionIpimumabThe group also reached both primary and secondary endpoints, showing statistically significant improvement in overall survival in tumor PD-L1-positive patients and in all random populations.OdivoUnionIpimumabThe group did not reach another major end point of the study, namely, the progression-free survival of patients with PD-L1-positive tumors as assessed by BICR.
In this studyOdivo及OdivoUnionIpimumabThe safety is consistent with that previously reported.
"the findings of Odevo-based combination therapy are an extremely important development for patients with esophageal cancer whose cancer has spread at the time of diagnosis, and are expected to bring them new treatment options in the future." Dr. Ian M. Waxman, head of gastrointestinal oncology research and development at Bristol-Myers Squibb, said, "the CheckMate-648 study further demonstrates our commitment to patients. We have always been committed to finding a combination of treatment strategies to help improve the prognosis of patients who lack treatment, such as gastrointestinal tumors. "
CheckMate-648research data are based on CheckMate-649research data. According to the results of these two clinical trials, Odevo has become the first and only PD-1/L1 inhibitor in the world that has been proven to have significant survival benefits in the treatment of malignant tumors of the upper digestive tract (including stomach, gastroesophageal junction and esophagus) in a variety of histological types and tumor sites. In addition, the results of these two studies complement previous clinical data and prove thatOdivoThe treatment of esophageal cancer metastasis from the late stage to the early stage of the disease can bring clinical benefits.
Bristol-Myers Squibb will complete a further evaluation of the CheckMate-648 research data and look forward to announcing the results at an academic conference in the near future. At the same time, the company will also share the results with various health authorities. Here, Bristol-Myers Squibb would also like to express its special thanks to all the patients and researchers who participated in the clinical study of CheckMate-648.
AboutCheckMate-648
CheckMate-648 is a phase III randomized clinical trial designed to evaluate compared with chemotherapy alone (fluorouracil + cisplatin)OdivoUnionIpimumab或OdivoEfficacy and safety of fluorouracil combined with cisplatin in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma.
The main end point of the study was compared with Odevo-based combination therapy and chemotherapy, and the overall survival time ((OS)) and progression-free survival ((PFS)) of PD-L1-positive patients with (BICR) were evaluated through a blind independent center. Secondary endpoints included overall survival and progression-free survival of all random populations assessed by BICR.
OdivoUnionIpimumabThe patients in the control group receivedOdivo3mg/kg union (every 2 weeks)IpimumabTreatment of 1mg/kg (once every 6 weeks) continues for 24 months or until the disease progresses or intolerable toxicity occurs.
OdivoPatients in the combined chemotherapy group receivedOdivo240mg (days 1 and 15) combined with fluorouracil 800 mg/m ²/ day (days 1 to 5, for a total of 5 days) and cisplatin 80 mg/m ²(day 1), every 4 weeks as a course of treatment. Patients continue to acceptOdivoTreatment up to 24 months or until disease progression or intolerable toxicity, and continue to receive chemotherapy until disease progression or intolerable toxicity.
About esophageal cancer
Esophageal carcinomaIt is the eighth most common cancer in the world and the sixth leading cause of cancer death. In 2020, there were about 604000 new cases and more than 544000 deaths worldwide. Squamous cell carcinoma ((ESCC)) and adenocarcinoma are still the two most common types, accounting for nearly 90% and 10% of the total number of patients with esophageal cancer, respectively. Most ESCC cases are concentrated in Asia, accounting for about 80 per cent of global ESCC cases in 2020. Most patients with esophageal cancer are diagnosed at an advanced stage and affect their daily life, including diet. Esophageal squamous cell carcinoma usually occurs in the upper and middle part of the esophagus, while adenocarcinoma originates from the cells of the mucous secretory glands of the esophagus, and most often occurs in the lower part of the esophagus.