On February 4th, Merck&Company announced that its PD-1 inhibitor pembrolizumab has been approved by the National Medical Products Administration (NMPA) of China for first-line treatment in combination with gemcitabine and cisplatin for locally advanced or metastatic biliary tract cancer (BTC) patients. The approval of this new indication is based on data from the global phase III clinical trial KEYNOTE-966.
Biliary tract malignant tumor is a type of malignant tumor originating from the epithelial cells of the bile duct, characterized by difficult early diagnosis, low curative resection rate, and high recurrence rate. Bile duct cancer mainly includes gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma. Among them, intrahepatic cholangiocarcinoma is the second largest primary liver cancer after hepatocellular carcinoma, accounting for approximately 10% to 15% of primary liver cancer.
"Bile duct cancer is a highly invasive tumor. Due to its insidious onset, unclear and atypical early symptoms, and rapid progression, most patients with bile duct cancer have reached the advanced stage when diagnosed. Unfortunately, advanced patients face limited treatment options, with a five-year survival rate of less than 5%, and there is an urgent need for new treatment methods and drugs to seek breakthroughs." Professor Qin Shukui from Nanjing Tianyinshan Hospital affiliated with China Pharmaceutical University.
The KEYNOTE-966 study is a randomized, double-blind, placebo-controlled international multicenter phase III clinical study aimed at evaluating the efficacy and safety of the PD-1 immune checkpoint inhibitor pembrolizumab combined with gemcitabine and cisplatin (GC) chemotherapy regimen compared to the GC regimen for first-line treatment of advanced or unresectable biliary tract cancer patients.
Ana Tian, senior vice president of MSD Global and president of China, said, "In recent years, the incidence rate of biliary malignant tumors has been on the rise, and the treatment options for advanced patients are limited. We will be committed to covering more malignant tumors with high incidence rate and mortality, low overall survival rate, and difficult treatment, and bring more innovative treatment options to cancer patients at a faster speed."
Up to now, Pabolizumab has been approved for 13 indications in China, covering the treatment of melanoma, lung cancer, esophageal cancer, colorectal cancer, head and neck cancer, gastric cancer, liver cancer, breast cancer, bile duct cancer and MSI-H solid tumor.