Why Did NuCana Stop Phase 3 Biliary Tract Cancer Trial?

NuCana plc NCNA will discontinue its NuTide:121 study following a pre-planned futility analysis by the study's Independent Data Monitoring Committee (IDMC). 

• The NuTide:121 Phase 3 trial assessed Acelarin plus Cisplatin in patients with previously untreated advanced biliary tract cancer.
• Although a higher objective response rate was observed in the Acelarin plus cisplatin arm, this did not translate into an overall survival benefit. 
• The IDMC concluded that Acelarin plus cisplatin was unlikely to achieve its primary objective of demonstrating at least a 2.2-month improvement in overall survival compared to the standard of care, gemcitabine plus cisplatin. 
• Acelarin plus cisplatin was generally well tolerated.
• In September, the FDA has granted Fast Track designation to Acelarin (NUC-1031) for the first-line treatment of advanced biliary tract cancer.
• The Company is moving forward with other ProTides in clinical development, NUC-3373, and NUC-7738. 
• The Company expects dosing the first patients in the Phase 3 study of NUC-3373 combined with other agents for colorectal cancer in 2H of 2022.
• NUC-7738 is entering Phase 2 development in solid tumors and lymphoma patients and expects to announce additional data in 2022. 
• Price Action: NCNA shares are down 55.8% at $1.30 during the premarket session on the last check Thursday.