Odivo assisted in the treatment of myocardial immersive urethrial skin cancer, which extended the disease-free survival of patients by nearly 2 times

On February 8, 2021, NYSE: BMY announced the results of a Phase III clinical study, CheckMate -274: Odivo (Navuliyu monoanti) The treatment of patients with high risk of recurrence of muscle-layer immersive urethroid cancer reached the main study endpoint in all random populations and PD-L1 expression ≥1% of patients, which significantly improved patient disease-free survival (DFS).
CheckMate-274 study was the first Phase III clinical study to evaluate immunotherapy as an auxiliary treatment for myospheric leaching urethra cancer and achieved positive results.
in all randomized populations, the mid-level 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; %(Risk ratio of 0.70; 98.31% confidence interval of .CI: 0.54 to 0.89, p.lt;0.001).
in PD-L1 expression ≥1% of patients, Odivo reduced the risk of recurrence or death by 47%, while the mid-DFS in Odysseotherapy and placebo control groups was not achieved and 10.8 was not achieved, respectively. Months (risk ratio of 0.53;98.87% confidence interval (CI: 0.34 to 0.84, p.lt;0.001).
the study data will be presented orally at the American Society of Clinical Oncology Reproductive Urological System Oncology Symposium (ASCO-GU) on February 12, 2021 at 16:36-16:46 EST.
" muscle-layer immersive urethra cancer patients usually need to undergo a bladder removal to save lives, but about 50 percent of patients still face postoperative recurrence.
"According to the CheckMate-274 clinical study, patients treated with Navuliyu monotherapy had nearly twice the disease-free life of the placebo group," said Dean Bajorin, M.D., a reproductive urologist at memorial Sloan Kettering Cancer Center.
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 improved efficacy at key secondary study endpoints, including non-urinary tract skin recurrence (NUTRFS, i.e., the patient's survival time without recurrence of the disease outside the bladder, ureter, or kidney).
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 (risk ratio of 0.72; 95 percent confidence interval (CI: 0.58 to 0.89).
In ≥1% of patients with PD-L1 expression, the mid-range NUTRFS in the Odivo treatment group and the placebo control group did not reach and 10.9 months, respectively (risk ratio of 0.54; 95% confidence interval (CI: 0.38 to 0.77).
study, Odivo'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.
"By moving the application of immunotherapy to the early stages of cancer, we will have the opportunity to intervene in the progress of the disease, reduce tumor recurrence, and deliver better treatment results for patients," said Dana Walker, M.D., director of the Pershing Mespresso Reproductive Urological Tumor Development Program.
we are pleased to see the clinical benefits of The CheckMate-274 results for cancer patients, as well as to all the patients and researchers involved in the trial.
we look forward to working with health authorities around the world to reach more patients with this treatment.
" About CheckMate-274CheckMate -274 is a randomized, double-blind, multi-center Phase III clinical study designed to assess the efficacy and safety of Odivo's comparative placebo for patients with high risk of recurrence of myocardial leaching 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.
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 (DFS≥ of all randomized patients (i.e., those who intended to treat) and tumor expression PD-L1≥1%.
critical secondary endpoints include total lifetime (OS), non-urethra skin recurrence (NUTRFS), and disease-specific lifetime (DSS).
about urethra cancer, which usually originates in the bladder, is the world's 10th most common tumor, with about 550,000 new confirmed cases worldwide each year.
in addition to the bladder, urethra cancer can occur in other parts of the urinary system, including the ureter and kidneys.
most urethra skin cancers can be diagnosed at an early stage, but the recurrence rate and progression rate of the disease is high, more than 50% of patients with leaching urethroid cancer who undergo a root resection will face recurrence after surgery.
recurrence was poor prognostic for patients with metastatic urethra skin cancer, and the total survival of the medium after systematic treatment was about 12 to 14 months.
about Odiodevo being approved as the world's first PD-1 inhibitor in July 2014 and has now been approved in 66 countries and territories with a total of 11 tumor species, covering lung cancer, head and neck Cancer, stomach cancer, esophageal cancer, liver cancer, kidney cancer, colorectal cancer, urethra cancer, melanoma, Hodgkin's lymphoma, thoracic tumors, benefiting more than 590,000 patients worldwide.
Odivo is the first approved immuno-oncology drug approved in China, currently approved in China the following 3 adaptation certificates, in addition to which no other adaptation certificate has been approved: 1) for the treatment of skin growth factor recipient (EGFR) gene mutation negative and mesolytic lymphoma kinase (ALK) negative, previously received platinum-containing course chemotherapy after disease progression or insuperable local late 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 PD-L1 tumor cells ≥1%); 3) for the treatment of patients with advanced or relapsed gastric or gastroesophageal adenocarcinoma 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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