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Merck (Merck KGaA) recently announced the top-line data from the second phase of the INTR@PID BTC 047 study.
A total of 159 patients were enrolled in the study.
Milind Javle, an investigator of the INTR@PID BTC 047 study and professor of gastrointestinal oncology at MD Anderson Cancer Center, said: “In view of the high unmet medical needs in BTC treatment, single-agent immunotherapy has a significant effect on all PD-L1 expression levels.
Danny Bar Zohar, MD, Head of Global Development, Merck's Healthcare Business Unit, said: "This study shows that bintrafusp alfa has single-agent activity against locally advanced or metastatic BTC, a disease that has historically been difficult to treat.
Currently, a Phase 2/3 study (INTR@PID BTC 055) is evaluating bintrafusp alfa combined with chemotherapy as the first-line treatment of BTC.
Cholangiocarcinoma-cholangiocarcinoma
Cholangiocarcinoma (BTC) is the general term for a group of rare aggressive gastrointestinal cancers, including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC) and gallbladder cancer (GBC).
bintrafusp alfa (M7824) is a dual-function immunotherapy, discovered by Merck internally, and is currently undergoing clinical development through a strategic alliance with GlaxoSmithKline.
Original source: Merck Reports Topline Data for Bintrafusp Alfa as Second-Line Monotherapy Treatment in Biliary Tract Cancer