Merck's Pembrolizumab (Keytruda®) Approved in China for First-Line Treatment of HER2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

On June 25, 2024, the global pharmaceutical giant Merck officially announced in its official statement that its highly anticipated PD-1 inhibitor pembrolizumab (brand name: Keytruda®) has been approved by the China National Medical Products Administration (NMPA) for use in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment for patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (Combined Positive Score (CPS) ≥1) based on a validated test.

This groundbreaking new indication approval is undoubtedly based on the excellent data from Merck's large-scale global Phase III clinical trial KEYNOTE-811.

Gastric cancer, a highly prevalent malignancy worldwide, poses an even greater challenge in China, with its incidence and mortality rates remaining alarmingly high. According to the latest data from the World Health Organization (WHO), China sees approximately 358,000 new cases of gastric cancer and around 260,000 deaths from the disease each year. Among these cases, the vast majority, over 95%, are of the adenocarcinoma subtype, making the treatment and prevention of gastric cancer of utmost importance.

Unfortunately, the early detection rate of gastric cancer in China is relatively low, accounting for only around 20% of the total cases. This means that most patients are diagnosed at more advanced stages, significantly increasing the difficulty and complexity of their treatment. Even more concerning is the dismal 5-year survival rate of less than 10% for patients with advanced gastric cancer, making it a formidable challenge.

Against this backdrop, the approval of Merck's pembrolizumab (Keytruda®) undoubtedly brings new hope and treatment options for gastric cancer patients. As a potent immune checkpoint inhibitor, pembrolizumab can inhibit the tumor's immune evasion mechanisms, activating the patient's own immune system to precisely target the tumor cells. In the KEYNOTE-811 clinical trial, pembrolizumab combined with other chemotherapeutic agents demonstrated excellent efficacy and safety, providing a new treatment strategy for gastric cancer patients.

This approval of the new indication for pembrolizumab (Keytruda®) not only marks a significant advancement in the treatment of gastric cancer in China but also showcases Merck's capabilities and commitment as a global pharmaceutical leader. We have every reason to believe that with further research and clinical application, pembrolizumab will play an increasingly important role in the treatment of gastric cancer, bringing hope to more patients.