Merck's PD-1 Inhibitor Keytruda® Approved in China for First-Line Treatment of HER2-Negative Gastric or Gastroesophageal Junction Adenocarcinoma

MSD’s PD-1 Inhibitor Keytruda® Approved in China for New Indication in Combination with Chemotherapy for Locally Advanced Unresectable or Metastatic HER2-Negative Gastric or Gastroesophageal Junction Adenocarcinoma

Keytruda® Receives Third Approval in China for First-Line Treatment of Gastrointestinal Tumors

Shanghai, China, December 18, 2023 — MSD (the corporate name of Merck & Co., Inc., Kenilworth, NJ, USA) announced that its PD-1 inhibitor pembrolizumab (trade name: Keytruda®) has been approved by the National Medical Products Administration (NMPA) of China for use in combination with fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. The approval of this new indication is based on data from the global Phase III clinical trial KEYNOTE-859.

Anna Tian
MSD Global Senior Vice President and President for China

This approval marks the third indication for pembrolizumab in the first-line treatment of gastrointestinal tumors in China. In the field of gastrointestinal tumors, pembrolizumab has been approved in China for the treatment of multiple types of cancers, including gastric cancer, colorectal cancer, liver cancer, and esophageal cancer, which rank second to fifth among the leading causes of cancer-related deaths in China. We are pleased to see that pembrolizumab can bring new treatment options to an increasing number of patients with gastrointestinal tumors, reaffirming our commitment to benefiting more patients in China through innovative therapies.

According to the latest data released by the WHO, China sees about 478,000 new cases of gastric cancer each year and approximately 373,000 deaths, ranking third in both new cancer cases and cancer-related deaths1. The vast majority of gastric cancers are adenocarcinomas, accounting for over 95%2. The proportion of early-stage gastric cancer patients in China is very low, only around 20%, with most patients already at an advanced stage upon diagnosis3. The five-year survival rate for advanced gastric cancer is less than 10%4.

Professor Shukui Qin
Principal Investigator of KEYNOTE-859 Study in China, President and Chief Physician of Nanjing Tianyin Mountain Hospital

It is currently known that the proportion of HER2-negative patients with gastric or gastroesophageal junction cancer exceeds about 80%5,6. China’s gastric cancer diagnosis and treatment guidelines have clearly stated that for the standard diagnosis of gastric cancer, in addition to the conventional histopathological type and Laurén classification, the HER2 expression status should also be determined3. We hope that with the approval of this new indication for pembrolizumab, Chinese patients with advanced gastric cancer can welcome more survival hope.

Dr. Li Zhengqing
President of MSD Global Senior Vice President and China Research Center

This approval marks an important milestone for patients with advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma. It also represents the 12th indication for pembrolizumab in China. HER2 is a crucial clinical target in gastric cancer treatment, and the accurate detection and assessment of HER2 protein expression and gene amplification status are vital for clinical diagnosis and treatment of gastric cancer. MSD has an extensive clinical research program in gastrointestinal cancers, and we will continue to bring new treatment options to more oncology patients in China.

References:
1.GLOBOCAN(2020)ChinaFactSheet
2. Ma Qianchen, Zhang Benyan, Rui Weiwei, Wang Ting, Luo Fangxiu, Wang Chaofu, Yuan Fei. Analysis of Pathological Types of 3071 Cases of Gastric Cancer in China [J]. Theory and Practice of Diagnostics, 2022, 21(05): 560-566.
3. Medical Administration Department of the National Health Commission of the People's Republic of China. (2022) Guidelines for the Diagnosis and Treatment of Gastric Cancer

Editor: Bai Ji

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