Merck's PD-1 Inhibitor Keytruda® Approved in China in Combination with Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Biliary Tract Cancer

Keytruda®Approved in China as the13Indication

ShanghaiFebruary 4, 2024PR Newswire -- MSD (the corporate name of Merck & Co., Inc., Kenilworth, N.J., USA) announced that its PD-1 inhibitor pembrolizumab (brand name: Keytruda®) has been approved by the National Medical Products Administration (NMPA) of China for first-line treatment in combination with gemcitabine and cisplatin for patients with locally advanced or metastatic biliary tract cancer (BTC). The approval of this new indication is based on data from the global Phase III clinical trial KEYNOTE-966.

"We are pleased to see that, driven by the full implementation of the Healthy China 2030 strategy, the review and approval process for innovative drugs continues to accelerate, particularly in terms of significantly improved accessibility for new drugs urgently needed in clinical practice."Anna Tian, Senior Vice President of MSD Global and President of MSD China"In recent years, the incidence of biliary tract malignant tumors has been on the rise."^[1], and treatment options for advanced patients are limited^[2]"As a leader in the field of cancer treatment, we are committed to addressing more malignant tumors with high incidence and mortality rates, low overall survival rates, and significant treatment challenges, while bringing more innovative treatment options to cancer patients at a faster pace."

Biliary tract malignant tumor is a malignant tumor originating from the epithelial cells of the bile duct, characterized by difficult early diagnosis, low radical resection rate, and high recurrence rate.^[3]Biliary tract cancer mainly includes gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma.^[4]Among them, intrahepatic cholangiocarcinoma is the second most common primary liver cancer, accounting for approximately 10% to 15% of primary liver cancers, only after hepatocellular carcinoma.^[5]。

"Biliary tract cancer is a group of highly aggressive tumors."^[6]Due to its insidious onset, non-obvious and atypical early symptoms, and rapid progression, most patients with biliary tract cancer are already in the advanced stage at the time of diagnosis.^[3].Regrettably, patients in the advanced stage face limited treatment options.^[2], with a five-year survival rate of less than 5%.^[4]", urgently seeking breakthroughs with new treatments and drugs."KEYNOTE-966Principal Investigator in China, Professor Shukui Qin from Nanjing Tianyin Mountain Hospital Affiliated to China Pharmaceutical University"The approval of the pembrolizumab combination regimen brings a new treatment option to a wide range of patients with biliary tract cancer, which is very encouraging."

"Patients with advanced biliary tract cancer often face a poor prognosis."^[2]Patients with bile duct cancer that is already in the advanced stage at the time of diagnosis have a survival time of less than one year.^[1]，" Dr. Li Zhengqing, Senior Vice President of MSD Global and President of MSD China Research Center"We look forward to the approval of pembrolizumab further addressing the urgent need for innovative treatment options in the field of biliary tract cancer therapy in China."