MSD's PD-1 Inhibitor Keytruda Approved for Esophageal Cancer, Adding to Its 21 Indications

VCBeat (WeChat ID: vcbeat) learned from foreign media reports that global biopharmaceutical giant MSD (Merck & Co.) recently announced that its anti-tumor drug Keytruda has received FDA approval for the treatment of esophageal cancer.

Keytruda is a PD-1 inhibitor that received FDA approval in September 2014, initially for the treatment of melanoma. Following five years of clinical research, the drug is now indicated for an additional 20 conditions, including non-small cell lung cancer, small cell lung cancer, head and neck cancer, primary mediastinal large B-cell lymphoma, gastric cancer, esophageal cancer, cervical cancer, and liver cancer. PD-1 inhibitors, also known as programmed death-1 inhibitors, have emerged as a focal point in oncology immunotherapy research in recent years, demonstrating exceptional breadth, depth, and durability of response.

Merck & Co., Inc. initially presented the clinical trial report for KEYTRUDA-181 at the ASCO Gastrointestinal Cancers Symposium (ASCO GI) in January 2019. The report detailed the treatment outcomes of 628 patients with esophageal cancer. Clinical data demonstrated that the chemotherapy regimen based on this drug reduced the risk of death by 31% compared to regimens using paclitaxel, docetaxel, or irinotecan. This marked the first time researchers identified a significant efficacy of PD-1 inhibitors in patients with gastrointestinal cancers.

Keytruda is a broad-spectrum anticancer drug, with over 1,000 clinical trials demonstrating its significant efficacy in the treatment of various cancers and other diseases.

Founded in 1891 and headquartered in New Jersey, USA, Merck & Co., Inc. (known as MSD outside the United States and Canada) is a leading biopharmaceutical company. The company is dedicated to developing innovative vaccines and oral medications for the treatment of various cancers, rare diseases, and inflammatory conditions, thereby improving patient outcomes. Listed on the New York Stock Exchange in January 1978 under the ticker symbol MRK, the company currently employs tens of thousands of people and operates in more than 140 countries worldwide.

In addition to its prescription drug business, MSD also conducts animal health operations in various countries, covering multiple areas such as the prevention, treatment, and control of diseases in livestock, poultry, and pets, with a commitment to safeguarding the health of both animals and humans.

Jonathan Cheng, a clinical research expert at MSD’s Oncology Research Laboratories, stated, “Treatment options for patients with advanced esophageal cancer are very limited, particularly as the disease progresses. Following FDA approval, Keytruda will become the first anti-PD-1 therapy indicated for the treatment of locally advanced recurrent or metastatic esophageal squamous cell carcinoma, providing patients with a new treatment option.”

Professor Takashi Kojima of the laboratory stated, “The prognosis for patients with esophageal cancer is poor; in the face of disease progression, hospitals lack first-line treatment options and there is no established standard of care. According to clinical data on Keytruda, the overall survival rate of patients with esophageal cancer has increased, representing a significant milestone in the history of human medicine.”

(Compiled by Xu Xiaoxue)