On March 2, 2022 NuCana plc (NASDAQ: NCNA) reported that the NuTide:121 study is being discontinued following a pre-planned futility analysis by the study’s Independent Data Monitoring Committee (IDMC) (Press release, Nucana BioPharmaceuticals, MAR 2, 2022, View Source [SID1234609374]). Although a higher objective response rate, as assessed by Blinded Independent Central Review, 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 as compared to the standard of care, gemcitabine plus cisplatin. Acelarin plus cisplatin was generally well tolerated.
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"This disappointing news highlights the challenges associated with developing new medicines for patients with biliary tract cancer," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "NuCana will carefully review these data to determine future potential development pathways for Acelarin. We are extremely grateful to all the patients, their families, the investigators and other health care professionals involved in the NuTide:121 study."
Dr. Jennifer J. Knox, Professor of Medicine at the University of Toronto, Clinician Investigator at the Princess Margaret Cancer Centre and Chief Investigator of the NuTide:121 study stated: "Biliary tract cancer comprises a very difficult group of tumors to treat and developing effective therapies in this setting is extremely challenging. I, along with the other NuTide:121 investigators, am dedicated to developing better treatment options for patients with biliary tract cancer. While the outcome of NuTide:121 is disappointing, it will not diminish our determination to address the unmet needs of these patients."
Mr. Griffith continued: "NuCana remains committed to improving the survival outcomes for patients with cancer. Our other ProTides in clinical development, NUC-3373 and NUC-7738, are based on unique chemical entities with distinct modes of action and we expect numerous data readouts and development milestones throughout 2022. NUC-3373 continues to generate promising data in the Phase 1b/2 colorectal cancer study and is entering a Phase 1/2 study in patients with solid tumors to identify additional indications for development. In addition, we anticipate dosing the first patients in the Phase 3 study of NUC-3373 combined with other agents for the treatment of patients with colorectal cancer in the second half of 2022. In the US alone, there are more than 145,000 patients diagnosed with colorectal cancer annually. Finally, NUC-7738 is entering Phase 2 development in patients with solid tumors and lymphoma and we expect to announce additional data in 2022. We are in a robust financial position to execute our strategic plan and generate important data readouts from our ongoing studies."