Heavyweight: Navuliyu monotherapy first-line treatment of stomach and esophageal cancer, significantly improving the total survival and non-progression survival.

on !-- 21, 2020, NYSE: BMY announced the main results of the key Phase III study, CheckMate-649.
Compared to individual chemotherapy, Odivo (Navulyu monoanti) combined chemotherapy first-line treatment of non-removable advanced or metastatic gastric cancer, gastroesophageal connecting cancer (GEJ) or esophageal adenocarcinoma patients achieved statistically significant and clinically significant total survival (OS) and progressive survival (PFS) benefits.
Odivo was the first PD-1 inhibitor to benefit patients significantly from OS and PFS in combination with chemotherapy for the treatment of stomach cancer, gastroesophageal joint cancer, or esophageal adenocarcinoma.
, OS and PFS benefits were observed in patients with PD-L1 expression-positive, or combined positive score (CPS) of 5, reaching the two main endpoints of the study.
also observed OS benefits in all random populations.
in patients with PD-L1 positive i.e. combined positive score (CPS) of 5, the mid-ODS in the Odivo combined chemotherapy group (risk ratio: 0.71; 98.4% confidence interval : 0.59-0.86; p.lt;0.0001) was 14.4 months (95% CI: 13.1-16.2) and the controlled individual chemotherapy group was 11.1 months (95% CI: 10.0-12.1).
PFS (HR: 0.68; 98% CI: 0.56-0.81; p.lt;0.0001) was 7.7 months (95% CI: 7.0-9.2) and 6.0 months (95% CI: 5.6-6.9) in the chemotherapy group alone.
the study, the safety characteristics of Odyssotherapy were consistent with the known safety characteristics of Odivo and chemotherapy, and no new safety signals were observed.
CheckMate-649 is by far the largest randomized, global Phase III study in a first-line treatment of stomach and esophageal cancer based on immunochemical checkpoint inhibitors.
"Currently, chemotherapy is the first-line standard treatment for patients with advanced or metastatic HER2-negative stomach or gastroesophageal connecting cancer.
chemotherapy is an important treatment option for these patients, first-time patients usually benefit from limited survival for less than a year after receiving chemotherapy alone.
Dr. Markus Moehler, Professor of Clinical Gastrointestinal Oncology, Johannes Guttenberg University Medical Center, Mainz, said, "With no immunotherapy program approved in the first-line treatment in this area, there is still an urgent need for innovative treatments for patients with advanced or metastasis gastrointestinal cancer worldwide."
" study showed that Odyssotherapy also showed significant statistical OS benefits in patients who were positive for PD-L1 and CPS1 and in all random populations.
in all random populations, the mid-OS in the Odivo combined chemotherapy group was 13.8 months (95% CI: 12.6-14.6) and in the individual chemotherapy group 11.6 months (95% CI: 10.9-12.5) (HR: 0.80;99.3% CI: 0.68-0.94; p=0.0002).
in patients who were positive for PD-L1 and had CPS1, the mesos in the Odivo combined chemotherapy group were 14.0 months (95% CI: 12.6-15.0) and in the individual chemotherapy group 11.3 months (95% CI: 10.6-12.3) (HR: 0.77; 99.3% CI: 0.64-0.92; p=0.0001).
"CheckMate-649 has recently become the first global study in more than a decade to achieve significant total lifetime benefits beyond chemotherapy in the first line of treatment for HER2-negative stomach, gastroesophageal connecting or esophageal adenocarcinoma.
, regardless of the specific site of the patient's tumor, Odivo combination chemotherapy treatment program is expected to become the first-line treatment of this part of the patient's new standard. "We will discuss the available data from the CheckMate-649 study with health authorities around the world to bring this important new treatment to patients who really need it," said Dr. Ian M. Waxman, head of research and development at
's Centennomics Gastrointestinal Oncology Group.
" In all levels of adverse events (TRAEs) associated with severe treatment at levels 3-4, the rate of occurrence in patients in the Odivo combined chemotherapy group (22 percent at all levels, 17 percent at levels 3-4) was slightly higher than in patients in the single chemotherapy group (12 percent at all levels, 10 percent at levels 3-4).
36% and 17% of patients in the Odevo combined chemotherapy group were suspended for all levels and 3-4 levels of TRAEs, respectively, while 24% and 9% were in the individual chemotherapy group.
data, the rates of TRAEs in the Odivo combined chemotherapy group were basically the same among patients in each subgroup.
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 gastric cancer, gastroesophageal connecting or esophageal cancer who have not been treated in the past with Navuliyu monotherapy or Navuliyu monoantigen monotherapy compared to individual chemotherapy.
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 monoantigen chemotherapy and OS from all random patients, as well as OS from patients treated with Navuliyu monoantigen monoantigen monoantigen chemotherapy and to the time of symptom deterioration (TTSD).
patients in the navuliyu monoantitor chemotherapy group were treated with Navuliyu monoantitor 360 mg combined capedabin and Osali platinum (CapeOX) every 3 weeks, or navuliyu monoantitor 240 mg combined with 5-fluoruriacine, folate and osaliptin (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, once every 3 weeks.
all patients continue to be treated for up to two years, or until the disease progresses, is insulable or withdraws informed consent.
about stomach cancer !--/ewebeditor:page--!--ewebeditor:page title"--gastric cancer is the fifth most common cancer in the world and the third leading cause of cancer death.
2018, there will be more than 1,000,000 new cases of stomach cancer and about 783,000 deaths worldwide.
, stomach cancer is the second largest type of cancer after lung cancer, with morbidity and mortality accounting 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 increasing.
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 death.
2018, there will be about 572,000 new cases of esophageal cancer and about 508,000 deaths worldwide.
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 terminally ill at the time of diagnosis and their daily lives, including their diet, are affected.
About Odiodivo was approved as the world's first PD-1 inhibitor in July 2014 and has been approved in 66 countries and territories for 11 tumors, covering lung, head and neck, stomach, esophageal, liver, kidney, colorectal, urethra, melanoma, Hodgkin's lymphoma, thoracic tumors, and more than 590,000 patients worldwide.
Odivo is the first approved immuno-oncology drug approved in China, currently approved a total of 3 adaptations in China, except for the following adaptation certificates have not yet been approved: 1) for the treatment of skin growth factor recipient (EGFR) gene mutation negative and mesozoic lymphoma kinase (ALK) negative, previously received platinum-containing course chemotherapy after disease progression or insuperable local late-stage or metastatic non-small cell lung cancer (NCLC) ) adult patients; 2) patients with relapsed or metastatic head and neck squamous cell carcinoma (SCCHN) who have developed the disease during or after treatment with platinum-containing programs and who have positive expression of tumor PD-L1 (expression of PD-L1 tumor cells by 1%); and 3) for the treatment of patients with advanced or relapsed stomach or gastroesophageal cancer who have previously received two or more systemic treatment options.
is the only PD-1 inhibitor developed directly by nobel laureates in physiology or medicine.
Meishi Shiguibao owns the exclusive use of Dr. Ben Yu's PD-1 patent.
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