NuCana (NCNA) Reports First Patient Dosed in Both US and Europe in Phase III Study of Acelarin (NUC-1031) for First-Line Treatment of Patients with Biliary Tract Cancer

NuCana plc (NASDAQ: NCNA) announced that the first patients have been dosed in its Phase III study of Acelarin (NUC-1031) plus cisplatin for the first-line treatment of patients with biliary tract cancer and that the study design is being presented at the ASCO-GI Conference in San Francisco. The enrollment of patients in NuTide:121 follows U.S. Food and Drug Administration (FDA) clearance of the company's investigational new drug application (IND) for Acelarin.

“We are pleased to have commenced dosing the first patients in our Phase III NuTide:121 study,” said Hugh Griffith, NuCana’s Chief Executive Officer. “Acelarin in combination with cisplatin has been shown in early clinical studies to achieve higher response rates compared to the current standard of care in patients with advanced biliary tract cancer, a devastating disease for which there is a significant need for more effective medicines.”

NuTide:121 is a global, multi-center, randomized Phase III study that is enrolling up to 828 patients in approximately 120 sites across North America, Europe, Asia and Australia. Patients are being randomized 1:1 and treated with either a combination of Acelarin (725 mg/m2) plus cisplatin (25 mg/m2) or the current standard of care regimen, gemcitabine (1,000 mg/m2) plus cisplatin (25 mg/m2).

NuCana also announced the presentation of a poster “NUC-1031 in combination with cisplatin for first-line treatment of patients with advanced biliary tract cancer (NuTide:121)” at the ASCO-GI Conference being held in San Francisco, CA. The poster details the study design of NuTide:121 and reviews the encouraging results previously reported in the Phase Ib ABC-08 Study. The poster may be found here.

The primary objectives of NuTide:121 are Overall Survival (OS) and Objective Response Rate (ORR). Three interim analyses, including two designed to support accelerated approval, are planned as part of the Phase III study protocol, in addition to the final analysis. Based on discussions with the FDA and subject to any further regulatory guidance, the Company believes that a statistically significant improvement in ORR at either of the first two interim analyses, supported by positive trends in other endpoints, could potentially allow for an accelerated approval of a new drug application (NDA) for Acelarin. Accelerated approval requires a confirmatory clinical study to verify the drug’s clinical benefit. If accelerated approval were to occur, NuTide:121 would continue and the Company anticipates that data from subsequent analyses could provide the confirmatory data to support full (regular) approval.

More information about this study may be found here.

About Biliary Tract Cancer

Biliary tract cancer, including cholangiocarcinoma, gallbladder and ampullary carcinoma, is cancer originating in the bile duct, a vessel that transports bile from the liver to the gallbladder and small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 18,000 of those diagnoses in the United States. There are currently no agents approved for the treatment of biliary tract cancer; however, the worldwide standard of care in biliary tract cancer patients with locally advanced or metastatic disease is the combination of gemcitabine and cisplatin. Patients receiving this regimen have a median overall survival of 11.7 months.

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