Odivo became the world's first first-line immunotherapy drug for gastric cancer approved by regulatory agencies

Bristol-Myers Squibb recently announced that the U.
S.
Food and Drug Administration (FDA) approved Odivo (Navulimab injection) combined with fluoropyrimidine and platinum-based chemotherapy drugs for the treatment of advanced or metastatic gastric cancer, gastroesophagus Patients with junctional carcinoma and esophageal adenocarcinoma, regardless of PD-L1 expression status
.

This approval is based on the results of the Phase III clinical study CheckMate -649

The results of the study on this patient population showed that in all random patient populations (overall survival [OS] hazard ratio [HR]: 0.
80; 95% confidence interval [CI]: 0.
71-0.
90; P=0.
0002) and PD-L1 In the patient population with positive expression and combined positive score (CPS) ≥5 (OS HR: 0.
71; 95% CI: 0.
61-0.
83; P<0.
0001), Odivo combined with chemotherapy showed significant OS benefits compared with chemotherapy alone
.

In addition, the results of an exploratory analysis of all patients showed that the one-year survival rate of patients in the Odivo combined chemotherapy group was 55%, and that of the chemotherapy alone group was 48% [2]

"CheckMate-649 study results show that Odivo combined with chemotherapy can significantly improve the survival of patients with metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, and reduce the risk of death by 20%
.

In addition, after one year of treatment, survival The proportion of patients is 55%

      Warnings and precautions for the use of Odivo treatment: serious and fatal immune-mediated adverse reactions, including pneumonia, colitis, hepatitis and liver toxicity, endocrine diseases, nephritis and renal insufficiency, skin adverse reactions, and other immune-mediated adverse reactions Reactions; Infusion-related reactions; Complications of allogeneic hematopoietic stem cell transplantation (HSCT); Embryo-fetal toxicity; When Odivo is used in combination with thalidomide analogs and dexamethasone, it increases the risk of multiple myeloma patients Mortality, therefore, is not recommended for use outside of controlled clinical trials
.

      "Throughout the past, there has been little progress in the treatment of patients with metastatic gastroesophageal adenocarcinoma, but we have always been committed to bringing breakthrough innovative drugs to patients in need
.

" General Manager of Bristol-Myers Squibb in the United States and oncology, immunology and Adam Lenkowsky, head of the Cardiovascular Division, said, “Based on the results of CheckMate-649 research, Odivo has become the first and currently the only one that can be used in combination with chemotherapy to bring patients with metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.

      *Odivo was approved as the world’s first PD-1 inhibitor in July 2014.
It has been approved for a total of 11 tumor types in 66 countries and regions, covering lung cancer, head and neck cancer, stomach cancer, esophageal cancer, liver cancer, Kidney cancer, colorectal cancer, urothelial cancer, melanoma, Hodgkin’s lymphoma, and pleural tumors benefit more than 590,000 patients worldwide
.

      Odivo is the first immuno-oncology drug approved for marketing in China.
It has been approved for a total of 3 indications in China.
Other indications have not been approved except for the following:

      1) For the treatment of epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative, disease progression or intolerable locally advanced or metastatic non-small cells after previous platinum-containing chemotherapy Adult patients with lung cancer (NSCLC);
      2) For recurrent or metastatic heads with disease progression during or after treatment with platinum-containing regimens and positive tumor PD-L1 expression (PD-L1 expression tumor cells ≥ 1%) Patients with squamous cell carcinoma of the neck (SCCHN);
      3) For the treatment of patients with advanced or recurrent adenocarcinoma of the stomach or gastroesophageal junction who have received two or more systemic treatments in the past
.

      Odivo is the only PD-1 inhibitor directly involved in the development of Nobel Prize winners in Physiology or Medicine 
.

Bristol-Myers Squibb has the exclusive right to use the PD-1 patent of Dr.
Shuyou Ben