Bristol-Myers Squibb Opdivo is approved for the third indication in China!

Cancer immunotherapy giant Bristol-Myers Squibb (BMS) recently announced that the Chinese National Drug Administration (NMPA) has approved the anti-PD-1 therapy Opdivo (generic name: nivolumab) for the treatment of two or more types of patients who have previously received Systemic treatment for patients with advanced or recurrent adenocarcinoma of the stomach or gastroesophageal junction.

Opdivo was approved for listing in China in June 2018 and became the first approved immuno-oncology (I-O) treatment drug in the Chinese market. The approval of the indication for gastric / gastroesophageal junction adenocarcinoma is also the third indication for Opdivo to be approved in China after non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (SCCHN).

The approval is based on data from the Phase III ATTRACTION-2 study, which is the world ’s first phase III clinical trial of gastric cancer immuno-tumor therapy. The study results for the first time clarified the effectiveness and safety of gastric cancer immunotherapy in the East Asian population, and also made Opdivo the first and so far the only PD confirmed by Phase III clinical studies to bring significant survival benefits to patients with advanced gastric cancer in China -1 inhibitor.

0010010 quot;In China, gastric cancer has become the second largest cancer after lung cancer, and its morbidity and mortality account for nearly 50% of the world. Among them, the main reason for the death to account for nearly half of the world is that about 80% of Chinese gastric cancer patients At the time of diagnosis, it is late, and there are few treatment options and limitations in efficacy. Therefore, it is the current primary goal to help these patients prolong their survival and improve their quality of life. 0010010 quot; Professor Lin said, 0010010 quot;ATTRACTION-2 study results confirm that the use of nivolumab injection in third-line or above third-line treatment of gastric cancer is safe, and once this part of the patient benefits, the survival time of 61.3% of the patients can be extended to More than two years. As the first immuno-oncology drug approved for gastric cancer treatment in China, nivolumab monoclonal injection breaks through the stalemate of 0010010 quot;backline drug shortage 0010010 quot; in the treatment of gastric cancer in China, and is expected to restore confidence in the treatment of advanced gastric cancer. Landmark. 0010010 quot;

0010010 quot;Odivo 0010010 #39;s expansion of indications to advanced gastric cancer in China demonstrates the speed and intensity of the Chinese government 0010010 #39;s efforts to benefit patients with innovative drugs. 0010010 quot; Ms. Chen Siyuan, President of Bristol-Myers Squibb China and Hong Kong, said, 0010010 quot;Bristol-Myers Squibb is committed to promoting China The determination to develop the treatment of high-risk diseases is obvious to all. This approval has brought more long-term survival hopes for Chinese patients with advanced gastric cancer, and successfully filled the 0010010 #39;gap 0010010 #39; in the treatment of advanced gastric cancer in China. As a pioneer in the field of immuno-oncology, We firmly believe that the potential of Odivo and Odivo-based combination therapy will continue to innovate and accelerate its application in more tumor types. At the same time, we have always been 0010010 #39;patient-centered 0010010 #39; through the cooperation with all sectors of society Work together to improve the accessibility of innovative drugs and benefit more Chinese patients. 0010010 quot;

Give life to the 0010010 quot;stomach 0010010 quot;, Chinese patients with advanced gastric cancer achieve significant survival benefits

The multi-center Phase III clinical trial ATTRACTION-2 study included patients from East Asia (including Taiwan, Japan, and South Korea) to evaluate Odivo 0010010 #39;s treatment of unresectable, advanced, or relapsed adenocarcinoma of the stomach and gastroesophageal junction Effectiveness and safety. The results showed that Opdivo reduced the risk of death by 38% compared to the control group selected in the study (median overall survival [OS]: 5.26 months vs 4.14 months; HR = 0.62 [95% CI: 0.51-0.76] , P 0010010 lt;0.0001), the one-year survival rate doubled to 27.3% (12-month survival rate: 27.3% vs 11.6%). In addition, in this trial, Odivo 0010010 #39;s safety was consistent with previous reports of solid tumor clinical trials, and the incidence of grade 3-4 treatment-related adverse events was 10%. Based on this result, Odivo became the world 0010010 #39;s first approved immuno-oncology drug for the treatment of advanced gastric cancer.

0010010 quot;The ATTRACTION-2 study pioneeredly confirmed that PD-1 inhibitors can achieve a long-term survival qualitative leap in patients with advanced gastric cancer. It is worth noting that the subgroup results of this study show that the population data of Taiwan and the overall population of China Consistently, compared with the control group, nivolumab antibody injection can significantly reduce the risk of death by 51%, which clarifies its added value for Chinese gastric cancer patients. 0010010 quot;Professor Shen Lin said, 0010010 quot; Gastric cancer immunity led by this study Based on the key data of treatment, PD-1 inhibitors have been unanimously recommended by domestic and foreign guidelines as a new standard for the treatment of gastric cancer in the third line or above. 0010010 quot;

Give life time, Bristol-Myers Squibb helps the development of gastrointestinal cancer prevention and treatment

0010010 nbsp;Digestive tract tumors led by gastric cancer have the characteristics of high incidence, late stage of disease and limited treatment in China. The data shows that of the top five tumor types with the highest mortality rate in China, gastrointestinal tumors account for four, including gastric cancer, liver cancer, esophageal cancer and colon cancer [3].

In order to further meet the unresolved treatment needs of high-incidence cancer patients in China, Bristol-Myers Squibb has conducted more than 30 clinical studies on immuno-oncology in China, most of which are phase III clinical studies, covering multiple gastrointestinal tumors.

While focusing on the research and development of innovative drugs, as a socially responsible enterprise, Bristol-Myers Squibb also actively participated in the 0010010 quot;Give Life to Time 0010010 quot; gastrointestinal tumors initiated by the China Cancer Association Rehabilitation Branch and supported by experts and celebrities from all walks of life Disease education project. Since 2019, the project will continue to carry out scientific work on the prevention, diagnosis and treatment of gastrointestinal tumors through the WeChat mini-program of 0010010 quot;giving time to life 0010010 quot; in order to increase public attention to gastrointestinal tumors and raise the population at high risk. The awareness of 0010010 quot;early diagnosis and timely treatment 0010010 quot; strengthens the patients 0010010 #39; belief of 0010010 quot;optimistic facing and active treatment 0010010 quot;.