NuCana plc (NASDAQ: 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.
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