Navuliyu monoantigen is used to treat the successful treatment of muscle layer immersion urethra cancer after rooting surgery (CheckMate -274 study)

On February 9th, Shishi Meishiguibao announced that a key Phase III clinical study called CheckMate-274 had reached the end-of-disease survival of the main study in all randomized populations and in 1≥1% of patients with tumor expression PD-L1≥1%.
CheckMate-274 is the first and only Phase III clinical study to have been shown as an auxiliary treatment for these patients to reduce their risk of recurrence.
study, Odivo's safety characteristics were consistent with those previously reported in other solid tumor clinical studies.
approved in July 2014 as the world's first PD-1 inhibitor, Odysseopathic has been approved in 66 countries and territories a total of 11 tumors, benefiting more than 590,000 patients worldwide.
in China, Odysseo is also the first approved immuno-oncology drug, which has been approved with three adaptation certificates.
CheckMate-274 is a randomized, double-blind, multi-center Phase 3 clinical study designed to assess the efficacy and safety of Odivo (Navuliyu monoanti) compared placebo for patients with high risk of recurrence of muscle-layer immersive urethroid cancer after surgery.
patients were admitted to the group regardless of whether they had received new complementary treatment before surgery, and whether participants received new complementary treatment with cisplatin was a strated factor in the study.
a total of 709 patients were randomly grouped at a 1:1 scale and treated with 240 mg of Odivo or placebo every two weeks for up to a year.
the main endpoint of the study was the disease-free survival of all randomized patients (i.e., those who intended to treat) and tumor expression PD-L1≥1% of patients.
critical secondary endpoints include total lifetime (OS), non-urethra skin recurrence (NUTRFS), and disease-specific lifetime (DSS).
study showed that in all randomized populations, the middle DFS (21.0 months) in the treatment group receiving Odivo was nearly doubled compared to the middle DFS (10.9 months) in the placebo control group;
In ≥1% of patients with PD-L1 expression, Odivo reduced the risk of recurrence or death by 47%, while the mid-level DFS in the Odivo treatment group and the placebo control group did not reach and 10.8 months, respectively.
Dr Dean Bajorin, M.D., a reproductive urologist at memorial Sloan Kettering Cancer Center, said: "Patients with myosome-immersive urethra cancer usually need to undergo a bladder removal to save their lives, but about 50 per cent of patients still face a postoperative recurrence.
, according to the CheckMate-274 clinical study, patients treated with Navuliyu monotherapy had nearly twice the disease-free lifeseavings of the placebo group.
the results are of great clinical significance and are expected to change the existing treatment methods for myospheric leaching urethra cancer to meet the urgent needs of patients for the effectiveness and tolerance of postoperative treatment.
In addition, Odevo showed improvements in efficacy at key secondary study endpoints, including non-urinary pathway skin recurrence (NUTRFS, i.e., the survival time of patients without recurrence of disease outside the bladder, ureter, or kidneys).
in all random populations, the mid-level NUTRFS in patients treated with Odivo was more than two years (24.6 months) and the placebo group was 13.7 months.
in ≥1% of patients with PD-L1 expression, the mid-level NUTRFS in the Odivo treatment group and the placebo control group did not reach and 10.9 months, respectively.
study, Odevo's safety characteristics were consistent with those previously reported in other solid tumor clinical studies.
treatment-related adverse events (TRAEs) were 77.5 per cent and 55.5 per cent, respectively, and the rates of stage 3 or 4 TRAEs were 17.9 per cent and 7.2 per cent, respectively.
Centennies plans to complete a comprehensive assessment of CheckMate-274 research data and work with researchers to present their findings at an upcoming academic conference, while Shishi Shishiguibao will also communicate with health authorities about the results.
The CheckMate-274 study will continue as planned, followed by an analysis of secondary endpoints such as total lifetime and disease-specific survival.
about urethra cancer, which usually originates in cells inside the bladder, is the 10th most common tumor in the world.
about 550,000 new confirmed cases worldwide each year.
addition to the bladder, urethra cancer can occur in other parts of the urinary system, including the ureter and kidneys.
most bladder cancers can be diagnosed at an early stage, but the recurrence and deterioration rates are high.
more than 50% of patients will face a recurrence of the disease after surgery.
for patients with advanced urethra skin cancer with metastasis, poor first-line treatment remission is a major clinical challenge, and second-line treatment is still limited.
About Odivo Odivo was approved as the world's first PD-1 inhibitor in July 2014 and has been approved in 66 countries and territories for a total of 11 tumors1, 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 and has been approved in China for the following three adaptations, among other things: 1) for the treatment of skin growth factor recipient (EGFR) gene mutation negative and mesozoic lymphoma kinase (ALK) negative, previously received platinum-containing 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 developed the disease during or after treatment with platinum-containing programs and who were positive for tumor PD-L1 expression (expression of tumor cells ≥1%); and 3) for the treatment of patients with advanced or relapsed gastric or gastroesophageal gland 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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