Keytruda® Receives its Third Approval for Digestive Tract Tumors in China

Shanghai, China - December 18, 2023: Merck, known as MSD outside the United States and Canada, announced that its PD-1 inhibitor, Pembrolizumab, marketed as Keytruda®, has received approval from 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. This new indication approval is based on data from the global Phase III clinical trial, KEYNOTE-859.

Tina Tian, Senior Vice President and President of Merck China, stated, "This approval marks the third indication for Pembrolizumab in first-line treatment of digestive tract tumors in China. Currently, Pembrolizumab has been approved for the treatment of multiple tumor types in the field of digestive tract cancers, including gastric cancer, colorectal cancer, liver cancer, and esophageal cancer, which rank among the top five cancer-related causes of death in China. We are delighted to see Pembrolizumab providing new treatment options for an increasing number of patients with digestive tract tumors, reaffirming our commitment to benefiting more patients in China through innovative therapies."

According to the latest data released by the World Health Organization (WHO), there are approximately 478,000 new cases of gastric cancer and 373,000 deaths annually in China, ranking third in both new and fatal cancer cases. The majority of gastric cancer cases are adenocarcinomas, accounting for over 95%. Early-stage gastric cancer accounts for a low proportion in China, with only about 20% of patients being diagnosed at an early stage. Most patients are diagnosed at advanced stages, where the five-year survival rate is less than 10%.

Professor Qin Shukui, Principal Investigator of KEYNOTE-859 study, Director, and Chief Physician of Nanjing Tianyinshan Hospital, commented, "Among patients with gastric or gastroesophageal junction cancer, over 80% are HER2-negative. The Chinese gastric cancer diagnosis and treatment guidelines have clearly indicated the importance of assessing HER2 expression status, in addition to routine pathological histological types and Lauren classification. With the approval of Pembrolizumab for this new indication, we hope that patients with advanced gastric cancer in China can embrace more hope for survival."

Dr. Li Zhengqing, Senior Vice President and President of Merck Global R&D Center China, said, "This approval represents a significant milestone for patients with advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma and marks the 12th indication for Pembrolizumab in China. HER2 is a clinically relevant target in gastric cancer, and accurate testing and evaluation of HER2 protein expression and gene amplification status are of great significance in the clinical diagnosis and treatment of gastric cancer. Merck has an extensive clinical research program in digestive tract cancers, and we will continue to bring new treatment options for more cancer patients in China."

In this dynamic landscape of cancer treatment, the approval of Pembrolizumab for a new indication underscores the continuous efforts and advancements in improving therapeutic options for patients with gastric or gastroesophageal junction adenocarcinoma. With its proven efficacy and commitment to oncology research, Merck remains dedicated to addressing the unmet needs of patients and improving outcomes in the fight against cancer.