On September 15, 2021 NuCana plc (NASDAQ: NCNA) reported it has completed enrollment of the number of patients in the ongoing Phase III NuTide:121 study required to conduct the first interim analysis (Press release, Nucana BioPharmaceuticals, SEP 15, 2021, View Source [SID1234587744]). The study, which is comparing Acelarin combined with cisplatin to the global standard of care, gemcitabine plus cisplatin, as a first-line treatment for patients with advanced biliary tract cancer, has enrolled 418 patients with measurable disease. The first interim analysis will be conducted after the 418th patient has completed 28 weeks of follow-up, which is expected to occur in the first half of 2022. NuCana believes that a statistically significant improvement in the Objective Response Rate (ORR) at the first interim analysis, accompanied by positive trends in other endpoints, has the potential to allow for accelerated approval of a new drug application (NDA) for Acelarin in the United States. Recruitment in the NuTide:121 study, which is intended to enroll up to 828 patients, is ongoing and NuCana believes subsequent analyses could provide the confirmatory data to support full (regular) approval.
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"We are very pleased to achieve this important enrollment milestone which brings us closer to our goal of developing more effective and safer medicines for patients with cancer," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "Biliary tract cancer is a devastating disease and there is a significant need for more effective medicines. We are especially grateful to all of the patients, their families, the investigators and other health care professionals involved in the NuTide:121 study."
Mr. Griffith continued: "The primary objective of the first interim analysis is to demonstrate at least a 14% improvement in the ORR in the Acelarin plus cisplatin arm compared to the gemcitabine plus cisplatin arm. In the ABC-08 study of Acelarin plus cisplatin as a first-line treatment for patients with biliary tract cancer, an ORR of 44% was achieved among the evaluable population. This compared favorably to the ORR of 26% achieved among evaluable patients treated with gemcitabine plus cisplatin in the ABC-02 study, which established this regimen as the global standard of care. We look forward to announcing the outcome of this first interim analysis in the first half of 2022."
About NuTide:121
NuTide:121 is a global, multi-center, 1:1 randomized Phase 3 study comparing Acelarin, a ProTide transformation of gemcitabine, in combination with cisplatin, to gemcitabine in combination with cisplatin in up to 828 patients with advanced biliary tract cancer who have not previously received treatment for advanced disease. The primary endpoints of NuTide:121 are Overall Survival (OS) and Objective Response Rate (ORR) and the FDA-approved protocol includes three interim analyses. Based on the statistical analysis plan, 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, accompanied by positive trends in other endpoints, has the potential to allow for an accelerated approval of a new drug application (NDA) for Acelarin in the United States. Under this scenario, the NuTide:121 study would continue and the Company believes it could use the data from subsequent analyses as the confirmatory data required to support full (regular) approval. There are currently no agents approved for the first-line treatment of patients with biliary tract cancer.
About Biliary Tract Cancer
Biliary tract cancer, including cholangiocarcinoma, gallbladder and ampullary carcinoma, are a group of cancers originating in the biliary tract. The biliary tract is comprised of the gallbladder and interconnecting ducts responsible for the transport of 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 first-line treatment of patients with advanced biliary tract cancer; however, the worldwide standard of care in these patients is the combination of gemcitabine and cisplatin. Patients receiving this regimen have a median overall survival of 11.7 months.