On February 22, 2022 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 second interim analysis, which is expected to occur in the second half of 2022 after the 644th patient has completed 28 weeks of follow-up (Press release, Nucana BioPharmaceuticals, FEB 22, 2022, View Source [SID1234608805]). The NuTide:121 study 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. As previously announced, NuCana expects to conduct the first interim analysis after the 418th patient has completed 28 weeks of follow-up, which is expected to occur in the first half of 2022.
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NuCana believes that a statistically significant improvement in the Objective Response Rate (ORR) at either of the first two 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. At the first interim analysis, an improvement in ORR of approximately 14% or more in the Acelarin plus cisplatin arm compared to the gemcitabine plus cisplatin arm would be statistically significant. Due to the larger number of patients included in the second interim analysis, an improvement in ORR of approximately 9% or more would be statistically significant. 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.
"We are delighted with the pace of enrollment in the NuTide:121 study especially against the backdrop of the Covid pandemic," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "With the enrollment of the 644th evaluable patient, we are now in position to complete two pre-specified interim analyses in 2022."
Mr. Griffith continued: "In the ABC-08 study of first-line patients with biliary tract cancer, Acelarin plus cisplatin achieved an ORR of 44% 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. Biliary tract cancer is a devastating disease and we believe Acelarin could represent a new option to help address the significant unmet need for more effective medicines."
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 16,000 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.