Breaking through the ten-year bottleneck, Odivo® combined chemotherapy was approved as the first and only first-line immunotherapy for advanced gastric cancer in China

On August 30, 2021, Bristol-Myers Squibb announced that Odivo (Navulimab injection) has been approved to add new indications in China
.

The National Medical Products Administration of China approved Odivo combined with fluorouracil and platinum-based chemotherapy for first-line treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma

On August 30, 2021, Bristol-Myers Squibb announced that Odivo (Navulimab injection) has been approved to add new indications in China

The approval is based on a key global phase III clinical study called CheckMate-649, which aims to evaluate Odivo combined chemotherapy and compare chemotherapy alone for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

In this study, the safety characteristics of Odivo combined with chemotherapy are consistent with the known safety characteristics of Odivo and chemotherapy, and no new safety signals have been observed
.
Taking the "Wo" first-line treatment opportunity and breaking the Chinese "stomach" problem solving the "Wo" first-line treatment opportunity to breaking the Chinese "stomach"
problem A total of more than 2000 patients were enrolled
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The study included 208 patients with gastric cancer and gastroesophageal junction cancer in mainland China, who were randomly assigned to the Odivo combined chemotherapy group or the chemotherapy group alone, and their proportion ranked first among all countries
.

"The latest cancer epidemic data of the National Cancer Center shows that the annual incidence of gastric cancer in China is 400,000, ranking first in the world.
The
CheckMate-649 study has included a considerable number of Chinese people, so its success is particularly useful for guiding and promoting the reform of gastric cancer clinical practice in China.
Significance
.
” Professor Lin Shen, deputy dean of Peking University Cancer Hospital, pointed out, “The results of the Chinese subgroup of the study show that the objective remission rate of Chinese patients receiving Odivo and chemotherapy combined treatment can reach 59%, and the risk of death is reduced by 39%.
The overall survival was improved to 14.
3 months compared with chemotherapy alone, which indicates that the first-line immune combined chemotherapy regimen is in line with the treatment practice of gastric cancer in China
.
The approval of Odivo is expected to completely revolutionize the first-line treatment standard for advanced gastric cancer in China
.

" In 2020, the number of new cases and deaths of gastric cancer in China will account for 44% and 49% of the global total, and about 80% of gastric cancer patients are in advanced or even advanced stages when they are discovered
.
Advanced patients are often treated due to weight loss and malnutrition.
Tolerability is reduced, so first-line treatment is the best opportunity for its curative effect
.
However, for most patients, the survival benefits brought by standard first-line chemotherapy in the past are very limited, and there is an urgent clinical need for innovative therapies that can bring hope for long-term survival
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"Professor Li Jin, director of the Department of Oncology, Oriental Hospital of Tongji University, Shanghai, said, "The milestone result of the CheckMate-649 study confirms that the Odivo-based treatment program has achieved the first in the first-line treatment of gastric cancer in the past ten years.
The major breakthrough is expected to open up a new situation for the problem of gastric cancer in China, and it also strengthens confidence in the in-depth research and expansion of immunotherapy in the field of gastric cancer and digestive tract
.
" Leading science to open a new era, co-expanding and protecting the lives of patients with the "stomach" Leading science to open a new era,
co-expanding the
lives of patients with the "stomach" Supported by the research results of CheckMate -649, Chinese Society of Clinical Oncology (CSCO) Both the National Comprehensive Cancer Network (NCCN) and the National Comprehensive Cancer Network (NCCN) have incorporated Odivo combined chemotherapy into the new version of the gastric cancer diagnosis and treatment guidelines, and unanimously recommend it for the first-line treatment of inoperable advanced or metastatic gastric cancer .

"In China, comprehensively deepen the reform of the drug approval system.
In the context, this time China was approved only 4 and a half months after the indication was approved by the U.
S.
Food and Drug Administration (FDA).
The'China Speed' has once again refreshed history
.
This also marks another milestone for Bristol-Myers Squibb to implement the "China 2030 Strategy" and accelerate the implementation of innovative drugs globally
.
Ms.
Chen Siyuan, President of Bristol-Myers Squibb China and Hong Kong, said, "Since Odivo was approved as the third-line indication for gastric cancer in 2020, and now it has been approved as the first first-line immunotherapy, Bristol-Myers Squibb is expected to redefine advanced gastric cancer in China.
Standard of treatment
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As a leader in the field of immuno-oncology therapy rooted in China, we have long been committed to the development of the treatment of the digestive tract and other high-incidence cancers; at the same time, we will continue to work with all parties in the society to improve the availability of drugs and change the lives of patients
.
"
Since Odivo became the first approved tumor immunotherapy drug in China in 2018, Bristol-Myers Squibb has always paid close attention to the accessibility of innovative treatments by Chinese patients, and has actively cooperated with all sectors of society to explore and promote the establishment of innovative drugs.
Hierarchical payment system, covering multiple models such as supplementary commercial medical insurance, patient assistance plans, etc. .
As of July 2021, Odiwo has been included in the reimbursement scope of 44 local commercial supplementary medical insurance projects across the country, of which 18 new projects will be added in 2021; at the same time, with the support of Bristol-Myers Squibb, China Cancer The Foundation (CFC) launched the Odivo Patient Assistance Project in 2019
.
With the approval of the new indication for Odivo, the China Cancer Foundation announced that the scope of Odivo’s patient assistance program will be expanded to the first-line treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma indications, and relieve patients Pay the pressure to help more patients obtain long-term survival opportunities
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