Bristol Myers Squibb Announces Opdivo as China's First Immuno-Oncology Therapy Approved for Advanced Gastric Cancer

Shanghai, March 13, 2020 /PRNewswire/ -- Bristol-Myers Squibb announced today thatOpdivo(Nivolumab Injection) has been officially approved by the China National Medical Products Administration for the treatment ofPatients with advanced or recurrent gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic treatment regimens. This is the first immuno-oncology (I-O) drug in China, following non-small cell lung cancer and head and neck squamous cell carcinomaOpdivoThe third indication approved in China.

This approval is based on the Phase III clinical study named ATTRACTION-2, which was the first Phase III clinical trial of immuno-oncology therapy for gastric cancer initiated worldwide. The results of this study clarified for the first time the efficacy and safety of immunotherapy for gastric cancer in East Asian populations, thereby enablingOpdivoIt has become the first and, to date, only PD-1 inhibitor proven by Phase III clinical trials to provide significant survival benefits for Chinese patients with advanced gastric cancer.

“In China, gastric cancer has become the second most common cancer after lung cancer”^[3], accounting for nearly 50% of the global incidence and mortality^[3,4]. The primary reason for this, with deaths accounting for nearly half of the global total, is that approximately 80% of gastric cancer patients in China are diagnosed at an advanced stage.^[5], there are few available treatment options, and their efficacy is limited. Therefore, the primary current goal is to help these patients prolong survival and improve quality of life.”Professor Shen Lin, Vice President of Peking University Cancer Hospital and Director of the Department of Gastrointestinal Medical Oncology, stated，“The ATTRACTION-2 study results confirmed that Nivolumab injection (”Opdivo) demonstrates a favorable safety profile in third-line or later treatment of gastric cancer, and patients in this population who derive benefit^[1], with 61.3% of patients surviving for more than two years^[2]“As the first immuno-oncology drug approved in China for the treatment of gastric cancer, nivolumab injection has broken the deadlock of ‘lack of later-line therapies’ in gastric cancer treatment in China, holding promise to restore confidence in the management of advanced gastric cancer and representing a milestone.”

“Opdivo“The expansion of indications to advanced gastric cancer in China underscores the speed and intensity with which the Chinese government is making innovative medicines accessible to patients.”Ms. Chen Siyuan, President of Bristol-Myers Squibb in Mainland China and Hong Kong, stated,“Bristol-Myers Squibb’s commitment to advancing the treatment of high-incidence diseases in China is evident to all. This approval brings hope for long-term survival to more Chinese patients with advanced gastric cancer, successfully filling the ‘gap’ in the treatment of advanced gastric cancer in China. As a pioneer in the field of immuno-oncology, we firmly believe”OpdivowithOpdivothe potential of combination therapies based on it, we will continue to innovate and accelerate the exploration of its applications in more tumor types. Meanwhile, we always remain ‘patient-centric,’ working closely with all sectors of society to improve the accessibility of innovative medicines and benefit more patients in China.”

"Stomach" for Life, Chinese Patients with Advanced Gastric Cancer Achieve Significant Survival Benefits

The multicenter Phase III clinical trial ATTRACTION-2 study enrolled patients exclusively from East Asia (including Taiwan, China, Japan, and South Korea), aiming to evaluateOpdivoEfficacy and Safety in the Treatment of Unresectable, Previously Treated Advanced or Recurrent Gastric and Gastroesophageal Junction Adenocarcinoma^[6]. The results showed that, compared with the control group selected for the study,OpdivoCan reduce the risk of death by 38%^[2], with the one-year survival rate doubling to 27.3%^[2]. In addition, in this trial,OpdivoThe safety profile was consistent with that reported in previous clinical trials of solid tumors, with a 10% incidence of grade 3–4 treatment-related adverse events.^[6]. Based on these results,Opdivobecame the first immuno-oncology drug approved globally for the treatment of advanced gastric cancer.

“The ATTRACTION-2 study pioneeringly confirmed that PD-1 inhibitors can enable patients with advanced gastric cancer to achieve a qualitative leap in long-term survival. Notably, the subgroup results of this study showed that the data from the Taiwan, China population were consistent with the overall population results. Compared with the control group, nivolumab injection significantly reduced the risk of death by 51%.”^[7], clarifying its added value for Chinese gastric cancer patients.”Professor Shen Lin stated,“Based on the pivotal data on gastric cancer immunotherapy led by this study, PD-1 inhibitors are now consistently recommended by domestic and international guidelines as the new standard for third-line or later treatment of gastric cancer.”

Adding Time to Life: Bristol-Myers Squibb Supports the Advancement of Gastrointestinal Cancer Prevention and Treatment

Gastrointestinal tumors, led by gastric cancer, are characterized by high incidence, late-stage diagnosis, and limited treatment options in China. Data show that among the five cancer types with the highest mortality rates in China, four are gastrointestinal tumors, including gastric cancer, liver cancer, esophageal cancer, and colorectal cancer.^[3]。

To further address the unmet treatment needs of patients with high-incidence cancers in China, Bristol-Myers Squibb has currently initiated more than 30 immuno-oncology clinical studies in China, the majority of which are Phase III trials covering multiple types of gastrointestinal tumors.

While focusing on the research and development of innovative drugs, Bristol-Myers Squibb, as a socially responsible enterprise, has also actively participated in the "Give Life Time" gastrointestinal cancer disease education project. This initiative was launched by the Rehabilitation Branch of the China Anti-Cancer Association and is jointly supported by experts and public figures from all sectors of society. Since 2019, the project has continuously carried out nationwide science popularization efforts on the prevention, diagnosis, and treatment of gastrointestinal cancers through the "Give Life Time" WeChat mini-program. These efforts aim to raise public awareness of gastrointestinal cancers, enhance high-risk groups' consciousness of "early diagnosis and timely treatment," and strengthen patients' belief in "facing the disease with optimism and pursuing active treatment."

Note:

^[1]Note: “Benefit” refers to the patient population achieving partial or complete response.

^[2] Chen L-T. et al. A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION‑2): 2‑year update data [J]. Gastric Cancer 2019(19).

^[3] WHO, Globocan 2018 China. Available from <http://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf>

^[4] WHO, Globocan 2018 World. Available from <http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf>

^[5] Lei Y., et al. Incidence and mortality of stomach cancer in China,2014[J].Chinese Journal of Cancer Research,2018,30(03):291-298.

^[6] Kang YK, et al. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Dec 2;390(10111):2461-2471. doi: 10.1016/S0140-6736(17)31827-5. Epub 2017 Oct 6.

^[7] Chao Y, et al. Nivolumab in Advanced Gastric or Gastroesophageal Junction Cancer Refractory to, or Intolerant of, at Least Two Previous Chemotherapy Regimens: a Taiwanese Subgroup Analysis of ATTRACTION-2 Study. Presented at the GEST (2019) Gastroenterological Society of Taiwan - 2019 Annual Meeting