Merck's PD-1 Inhibitor Keytruda Approved in China for First-Line Treatment of Esophageal or Gastroesophageal Junction Cancer

SHANGHAI, Sept. 6, 2021 /PRNewswire/ -- Merck Sharp & Dohme (MSD), the corporate name for Merck & Co., Inc. in Kenilworth, New Jersey, USA, announced that its PD-1 inhibitor pembrolizumab (brand name: KEYTRUDA®) has been approved by China's National Medical Products Administration (NMPA) in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma. The approval of this new indication is based on data from the global pivotal Phase 3 clinical trial KEYNOTE-590.

“Esophageal cancer is the fifth most common malignant tumor in China”^[1], patients have long faced the challenge of limited treatment options,"Anna Tian, Global Senior Vice President and President, China at MSD, said，“We believe this approval will enable more patients with esophageal or gastroesophageal junction cancer to benefit from cutting-edge treatment options. This also further underscores our unwavering determination and commitment to consistently prioritizing patient needs and ensuring that innovative treatment regimens can promptly reach and benefit more patients in China.”

Esophageal cancer has long been a major malignancy threatening the health of the Chinese population.^[2]According to the latest data released by the World Health Organization, in 2020, China recorded approximately 320,000 new cases and 300,000 deaths from esophageal cancer, both accounting for more than half of the global totals.^[1],[3]. The symptoms of early-stage esophageal cancer are generally subtle, commonly manifesting as a recurrent foreign body sensation or choking sensation when swallowing food, or retrosternal pain. Once these symptoms persist, or when there is a noticeable choking sensation or dysphagia during swallowing, it indicates that the esophageal cancer has progressed to an intermediate or advanced stage.^[2]。

“In China, approximately 70% of esophageal cancer patients present with intermediate or advanced-stage disease at diagnosis, losing the opportunity for curative surgical resection, with a five-year survival rate of only 15%–20%.”^[2], and therapeutic approaches have seen few breakthroughs for a long time,”Professor Shen Lin, Vice President of Peking University Cancer Hospital, Director of the Department of Gastrointestinal Oncology, and Deputy Director of the Beijing Institute for Cancer Research, pointed out，“The approval of this new indication for pembrolizumab not only provides a new first-line treatment option for patients with unresectable locally advanced or metastatic esophageal cancer, but is also expected to update clinical practice guidelines in China, thereby transforming the treatment paradigm for esophageal cancer in China.”

“Pembrolizumab as`World's First`Tumor Immunotherapy for First-Line Treatment of Esophageal Cancer，will bring a milestone breakthrough to esophageal cancer treatment in China,”Dr. Li Zhengqing, Senior Vice President and President of MSD's China Research and Development Center, stated，“We will continue to actively explore more approaches and possibilities with the potential to transform cancer treatment, enabling innovative therapeutic regimens to address a broader spectrum of malignant tumors characterized by high incidence, low overall survival rates, and significant treatment challenges, thereby benefiting more Chinese patients。”

[1] IARC. Globocan 2020 China.

[2] Guidelines for the Diagnosis and Treatment of Esophageal Cancer (2018 Edition). Chinese Journal of Digestive Diseases and Imaging (Electronic Edition), 9(4):35.

[3] IARC. Globocan 2020 World.