Merck KGaA. (8/23/21). "Press Release: Merck Statement on Phase II Study of Bintrafusp Alfa in First-Line Treatment of Biliary Tract Cancer". Darmstadt.

	Organisation	Merck KGaA
	Group	Merck (DE) (Group)
	Organisation 2	GlaxoSmithKline plc (LSE: GSK, NYSE: GSK)
	Today	GSK plc (LSE: GSK, NYSE: GSK)
	Group	GSK (Group)
	Product	bintrafusp alfa (M7824, MSB0011359C)
	Product 2	phase 2 study

COMPANY STATEMENT

Based on a review of data conducted by the Independent Data Monitoring Committee (IDMC), Merck has decided to discontinue the Phase II INTR@PID BTC 055 study evaluating bintrafusp alfa with gemcitabine plus cisplatin in the first-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC), as the study is unlikely to achieve the primary objective of overall survival. No new safety signals were identified.

Health authorities and trial investigators are being notified of the decision and patients currently receiving bintrafusp alfa in the trial will be advised about next steps by their investigators.

Merck thanks the investigators and the patients and their families who participated in this clinical trial. We will share the data and analyses from this study with the scientific community in the future.

Bintrafusp alfa (M7824), discovered in-house at Merck, is currently in clinical development through a strategic alliance with GSK.

*Bintrafusp alfa is not approved for any use anywhere in the world.

Record changed: 2023-06-05