08302021

Opdivo® combination chemotherapy regimen approved as China's first and only first-line immunotherapy for advanced gastric cancer

Breaking through the ten-year bottleneck of first-line treatment and reshaping the treatment pattern of advanced gastric cancer in China

· The Opdivo combination chemotherapy regimen is the first and currently the only immunotherapy approved for the first-line treatment of advanced gastric cancer in China, and is not restricted by PD-L1 expression levels;

· Opdivo is currently the only PD-1 inhibitor that has been confirmed by global phase III clinical studies to have a significant overall survival benefit when combined with chemotherapy as a first-line treatment for advanced gastric cancer;

· Among Chinese patients, patients who received Opdivo combined with chemotherapy achieved clinically significant double benefits in overall survival and progression-free survival compared with chemotherapy, and achieved a higher objective response rate.

BMS

30/08/21

(Shanghai, China - August 30, 2021) Bristol-Myers Squibb announced today that Opdivo (nivolumab injection) has been approved for new indications in China. The China National Medical Products Administration has approved Opdivo combined with fluorouracil and platinum-based drug chemotherapy for the first-line treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. This is China's first immuno-oncology (I-O) drug approved for first-line treatment indications of advanced gastric cancer; Opdivo is also the only PD-1 inhibitor currently approved for gastric cancer indications in China.

The approval is based on a global pivotal Phase III clinical study called CheckMate -649, which aims to evaluate the efficacy and safety of Opdivo combined with chemotherapy compared with chemotherapy alone for the first-line treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in global populations (including Chinese patients). CheckMate -649 is the world's first Phase III study to prove that immunotherapy combined with chemotherapy brings significant survival benefits to first-line gastric cancer patients compared with chemotherapy alone. It is also the only clinical study to achieve dual benefits in overall survival (OS) and progression-free survival (PFS). The benefits of Chinese patients are consistent with the overall global population [1]: In all randomized populations, the median OS and median PFS of the Opdivo combined with chemotherapy group were 14.3 months and 8.3 months; the median OS and PFS of the chemotherapy alone group were 10.3 months and 5.6 months respectively. The objective response rate (ORR) was 59% in the Opdivo plus chemotherapy group and 41% in the chemotherapy alone group.

In this study, the safety profile of Opdivo combined with chemotherapy was consistent with the known safety profile of Opdivo and chemotherapy, and no new safety signals were observed.

Take the first-line treatment opportunity for "Wo" and solve China's "stomach" problems

CheckMate -649 is the largest clinical study of gastric cancer immunotherapy conducted to date, enrolling more than 2,000 patients worldwide. The study included 208 patients with gastric cancer and gastroesophageal junction cancer in mainland China, who were randomly assigned to the Opdivo combination chemotherapy group or the chemotherapy alone group, ranking first among all countries.

"The latest cancer epidemic data from the National Cancer Center shows that the annual incidence of gastric cancer in China reaches 400,000 [2], ranking first in the world. The CheckMate -649 study included a considerable number of Chinese people, so its success is particularly meaningful in guiding and promoting changes in the clinical practice of gastric cancer in China." Professor Shen Lin, Vice President of Peking University Cancer Hospital, pointed out, "The results of the Chinese subgroup of this study show that Chinese patients receiving Opdivo and chemotherapy The objective response rate of combination therapy can reach 59%1, the risk of death is reduced by 39%1, and the median overall survival time is improved to 14.3 months1 compared with chemotherapy alone. This indicates that the first-line immunotherapy combination chemotherapy regimen is in line with the treatment practice of gastric cancer in China. The approval of Odivo is expected to comprehensively revolutionize the first-line treatment standard of advanced gastric cancer in China. "

"In 2020, the number of new gastric cancer cases and deaths in China accounted for 44% and 49% of the world's total respectively[3],[4], and about 80% of gastric cancer patients are in the advanced stage or even the advanced stage when discovered[5]. Advanced patients often have reduced tolerance to treatment due to weight loss and malnutrition, so first-line treatment is their best chance to achieve curative effect. However, for the vast majority of patients, the survival benefits of previous first-line standard chemotherapy are very limited, and there is an urgent clinical need for innovative therapies that can bring hope for long-term survival." Professor Li Jin, Director of the Department of Oncology, Dongfang Hospital Affiliated to Tongji University in Shanghai, said, "This landmark result of the CheckMate -649 study confirms that Opdivo-based treatment has achieved the first major breakthrough in the field of first-line treatment of gastric cancer in the past decade. It is expected to open up a new situation for the problem of gastric cancer in China, and 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, and jointly expanding the lives of patients who can protect their "stomach"

Supported by the research results of CheckMate -649, the Chinese Society of Clinical Oncology (CSCO) and the National Comprehensive Cancer Network (NCCN) have included Opdivo combined with chemotherapy into the new gastric cancer diagnosis and treatment guidelines, and unanimously recommend it for the first-line treatment of inoperable advanced or metastatic gastric cancer.

"In the context of China's comprehensive deepening of the reform of the drug approval system, this approval in China was only four and a half months after the indication was approved by the U.S. Food and Drug Administration (FDA), and 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 launch of innovative drugs around the world." said Ms. Chen Siyuan, President of Bristol-Myers Squibb in Mainland China and Hong Kong. , "Since Opdivo was approved as a 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 the treatment standards for advanced gastric cancer in China. As a leader in the field of immuno-oncology treatment rooted in China, we have long been committed to the development of treatments for digestive tract and other high-risk cancers; at the same time, we will continue to work with all parties in society to improve drug accessibility and change patients' lives."

Since Opdivo 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 to Chinese patients and actively cooperated with all sectors of society to explore and promote the establishment of innovative multi-level payment systems, covering various models such as supplementary commercial medical insurance and patient assistance plans. As of July 2021, 44 local commercial supplementary medical insurance projects across the country have included Odivo in the reimbursement scope, including 18 new projects in 2021; at the same time, with the support of Bristol-Myers Squibb, the China Cancer Foundation (CFC) launched the Odivo patient assistance project in 2019. With the approval of new indications for Opdivo, the China Cancer Foundation announced that the scope of the Opdivo patient assistance project will be expanded to first-line treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma indications, reducing patients' payment pressure and helping more patients gain a chance of long-term survival.

[1] Shen, L. et. al. 2021, First-line nivolumab plus chemotherapy versus chemotherapy in patients with advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma: CheckMate 649 Chinese subgroup analysis, AACR 2021, presentation number CT184, April 2021.

[2] Zhang SW, Sun KX, Zheng RS, Zeng HM, Wang SM, Chen R, Wei WQ, He J. Cancer incidence and mortality in China, 2015[J]. JNCC, 2020, 1(1):2-11. DOI: https://doi.org/10.1016/j.jncc.2020.12.001.

[3] WHO, Globocan 2020 World. Available from https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf

[4] WHO, Globocan 2020 China. Available from https://gco.iarc.fr/today/data/factsheets/populations/160-china-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.