Phase III clinical study of Odivo (Navulimab) adjuvant treatment of esophageal cancer and gastroesophageal junction cancer after surgery, CheckMate-577 reached the primary endpoint of disease-free survival

On August 11, 2020, NYSE: BMY announced that a project called CheckMate-649 was designed to evaluate the use of Odivo (Navuliyu monomatic) combined chemotherapy for PD-L1 expression positive, or combined positive score (CPS) compared to individual chemotherapy. The key Phase III clinical studies of the first-line therapeutic effect of metastatic gastric cancer, gastroesophageal connecting cancer or esophageal adenocarcinoma patients reached the total end-of-life (OS) and non-progressive survival (PFS) of the main study;
OS benefits were also observed in all random populations.
is the first and only PD-1 inhibitor to be used in combination with chemotherapy, and both OS and PFS are superior to PD-1 inhibitors for chemotherapy alone.
study, the safety characteristics of Odivo combined chemotherapy were consistent with those of known Odivo and first-line chemotherapy for stomach and esophageal cancer.
" there is an urgent need to improve treatment for patients with esophageal and stomach cancers.
response to current standard chemotherapy was short-lived, and less than 6 percent of metastasis patients survived for more than five years.
"The immunotherapy has revolutionized the way we treat patients with different types of tumors," said Dr. Yelena Y. Janjigian, lead researcher at CheckMate-649 and director of the Gastrointestinal Oncology Department at Sloan-Kettering Cancer Center.
the results of the much-anticipated CheckMate-649 study are expected to provide patients with survival benefits that are superior to standard chemotherapy.
" "CheckMate-649 is the largest clinical study ever conducted in the field of stomach and esophageal cancer.
results show that Odevo combined chemotherapy will hopefully change the first-line treatment pattern of stomach cancer, gastroesophageal joint cancer or esophageal adenocarcinoma, and become a new standard of treatment for such patients. "We look forward to working closely with health administrations around the world to bring this immunotherapy-based treatment option to patients as soon as possible," said Dr. Ian M. Waxman, head of research and development at
's Hundred Mercies Gastrointestinal Cancer Group.
" Shishi Shiguibao will complete a comprehensive assessment of the available data from the CheckMate-649 study and work with the researchers to present the results at a later academic conference.
, the study and its results will also be discussed with the health administration.
addition, the CheckMate-649 study evaluated the effectiveness of Odivo's combined epipentherapy chemotherapy for patients with stomach cancer, gastroesophageal connecting cancer, or esophageal adenocarcinoma.
this part of the study is still in the process of data maturing, hundreds of meishi Guibao blind to this data.
Navuliyu monoantior has not yet been approved Chinese mainland esophageal cancer adaptation certificate in the united States.
ibimu monoantiton has not yet been approved Chinese mainland the world.
About CheckMate -649CheckMate-649 is a Phase III randomized, multi-center, open-label clinical study designed to assess the efficacy of those with HER2-negative, advanced or metastatic stomach cancer, gastroesophageal joint cancer, or esophageal adenocarcinoma for the treatment of her2-negative, advanced or metastatic gastric cancer or esophageal cancer compared to individual chemotherapy.
patients in the navuliyu monoantitor combination chemotherapy group were treated with navuliyu monoantitor 360 mg combined kapitabin and Osali platinum (CapeOX) once every 3 weeks, or navuliyu monoantitor 240 mg combined with 5-fluorouracil, folate and oxaliplatin (FOLFOX) every 2 weeks.
Navuliyu single anti-combined Ipimu monoantigroup patients received Navuliyu single resistance 1 mg/kg combined Ipimu single resistance 3 mg/kg treatment, once every 3 weeks, after four cycles of continuous drug use, sequential Navuliyu single resistance 240 mg, every 2 weeks.
chemotherapy group received FOLFOX treatment every 2 weeks, or CapeOX treatment, every 3 weeks.
all patients continue to be treated for up to two years, or until the disease progresses, is insulable to toxicity or withdraws informed consent.
the main endpoints of the study were the total survival (OS) of patients with PD-L1 expression-positive i.e. combined positive score (CPS) of 5 compared to individual chemotherapy, and the progress-free survival (PFS) assessed by the Independent BlindNess Central Review Committee (BICR).
Key secondary endpoints include CPS1 patients treated with Navuliyu mono-anti-combination chemotherapy, as well as OS from all random patients, and OS and to symptom worsening time (TTSD) in patients treated with Narvulyu monoantigen monoantigen monoantitic chemotherapy.
about stomach cancer, which is the fifth most common cancer in the world and the third leading cause of death.
china, stomach cancer is the second largest tumor after lung cancer, and its morbidity and mortality rate account for 44% and 50% of the global incidence and death of stomach cancer, respectively.
broad definition of stomach cancer, including gastroesophageal joint (GEJ) cancer, which forms at the junction of the stomach and esophageal, can be attributed to stomach cancer.
compared with stomach cancer, the prevalence of gastroesophageal cancer is low, but it is on the rise.
because many patients with stomach cancer are unable to withstand follow-up treatment due to the deterioration of their condition, first-line treatment is often the best chance for patients with stomach or gastroesophageal cancer to achieve results.
about esophageal cancer is the seventh most common cancer in the world and the sixth leading cause of cancer death.
Although the histological characteristics of esophageal cancer vary by region, squamous cell carcinoma and adenocarcinoma are still the two most common types, accounting for nearly 85% and 15% of the total number of esophageal cancer patients, respectively.
most people with esophageal cancer are diagnosed with advanced stages and their daily lives, including their diet, are affected.
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