NuCana halts phase 3 study of acelarin for biliary tract cancer
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A phase 3 study of acelarin in combination with cisplatin for biliary tract cancer is being discontinued at the recommendation of the study’s independent data monitoring committee, according to a press release from the agent’s manufacturer.
The decision follows a preplanned futility assessment performed at the first interim analysis of the NuTide:121 study.
The study evaluated acelarin (NUC-1031, NuCana) — a chemical modification of gemcitabine — plus cisplatin vs. standard-of-care gemcitabine plus cisplatin among patients with advanced biliary tract cancer.
The acelarin regimen appeared well-tolerated and conferred a higher objective response rate as assessed by blinded independent central review; however, that did not translate to an OS benefit. The data monitoring committee concluded that the regimen would be unlikely to meet the primary objective of a 2.2-month or longer improvement in OS vs. gemcitabine and cisplatin.
“Biliary tract cancer comprises a very difficult group of tumors to treat and developing effective therapies in this setting is extremely challenging,” Jennifer J. Knox, MSc, MD, FRCPC, professor of medicine at University of Toronto, clinician investigator at Princess Margaret Cancer Centre and chief investigator of the NuTide:121 study, said in the press release. “While the outcome of NuTide:121 is disappointing, it will not diminish our determination to address the unmet needs of these patients.”
NuCana has two other agents in clinical development.
NUC-3373, a chemical entity derived from the chemotherapy agent 5-FU, is under investigation in a phase 1b/phase 2 study for patients with metastatic colorectal cancer. NUC-7738, which the company described as a transformation of the novel anticancer nucleoside analog 3’-deoxyadenosine, is entering phase 2 development for patients with solid tumors or lymphoma.
“[These] other ProTides ... are based on unique chemical entities with distinct modes of action, and we expect numerous data readouts and development milestones throughout 2022,” Hugh S. Griffith, founder and CEO of NuCana, said in the press release.
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