Merck’s anti-PD-1 therapy was approved by the National Medical Products Administration (NMPA) in China in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or gastroesophageal junction (GEJ). This new indication was granted approval based on overall survival (OS) findings from a Phase 3 KEYNOTE-590 trial. KEYTRUDA is now approved for eight indications across five different types of cancer in China.
“In China, esophageal and gastroesophageal junction cancers are leading causes of death, and there have been few treatment advances for patients over the past several decades,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “With this approval of KEYTRUDA plus chemotherapy – the first for an anti-PD-1 regimen in the first-line setting – we can now provide patients with an immunotherapy treatment option earlier in the course of treatment that has been shown to significantly improve survival.”
“Compared to the rest of the world, China has a disproportionate number of patients who are diagnosed with and who die from esophageal cancer, the fifth most commonly diagnosed cancer and the fourth leading cause of cancer-related death in the country,” said Prof. Shen Lin, vice president, Clinical Oncology, Beijing Cancer Hospital and Peking University, and deputy director, Beijing Institute for Cancer Research. “This approval for KEYTRUDA provides an important new option to patients with advanced esophageal carcinoma in China who currently have limited available treatment options in the first-line setting.”
“We are thrilled to bring this new KEYTRUDA combination treatment option, which has shown significant improvements in progression-free and overall survival, to esophageal cancer patients in China,” said Anna Van Acker, president, MSD China. “We continue to work with urgency to address the unmet needs of patients in China through our broad global clinical program, and we are committed to working with stakeholders to ensure patient access.”
This is the second indication for KEYTRUDA in esophageal cancer in China. In addition to this new approval, KEYTRUDA is approved in China for a second-line treatment of certain patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10). Merck is continuing to study KEYTRUDA across multiple settings and stages of gastrointestinal cancer through its broad clinical program, including studies in esophageal, gastric, hepatobiliary, pancreatic, colorectal and anal cancers.
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