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FDA授予NUC-1031治疗胆管癌的快速通道指定
Cholangiocarcinoma is highly malignant and has a poor prognosis. According to statistics, in the United States, there are about 10,000 new cases of cholangiocarcinoma every year. There are more cholangiocarcinoma patients in Asia, with an incidence rate of about 3 in 100,000. For a long time, the medical community has been exploring new treatment methods, hoping to change the clinical treatment pattern of cholangiocarcinoma.
The FDA has granted Fast Track designation to NUC-1031 (acelarin), a first-in-class nucleotide analog, as a potential first-line treatment option for patients with advanced biliary tract cancer, according to a press release from NuCana plc.
NUC-1031 represents a new class of anticancer drugs designed to overcome gemcitabine resistance mechanisms. The plasma stability of NUC-1031 is higher than gemcitabine, 8.3 hours and 1.5 hours respectively; the intracellular level of dFdCTP is increased (dFdCTP is an active anti-cancer metabolite with less toxicity).
(Source: Internet)
NUC-1031 + cisplatin and gemcitabine + cisplatin are currently being studied as part of the Phase 3 NuTide:121 trial (NCT04163900) for the first-line treatment of patients with advanced biliary tract cancer.
Previously, NUC-1031 had early clinical activity in patients with heavily pretreated platinum-resistant ovarian cancer, based on preliminary results from the Phase 2 PRO-105 trial (NCT03146663).
The randomized, open-label, 2-part PRO-105 trial is designed to determine the optimal dose of NUC-1031 in patients with 3 or more prior lines of platinum-resistant ovarian cancer. The trial included heavily pretreated patients with a median of five prior lines of therapy, with 72% of patients having at least one complication at study entry.
In Part 1 of the trial, patients were randomly assigned to receive either 500 mg/m2 of NUC-1031 or 750 mg/m2 of NUC-1031, with all patients receiving treatment on days 1, 8 and 15 of a 28-day treatment cycle. Randomization was stratified according to BRCA1/2 mutation status and the number of patients who had previously received chemotherapy.
Among 45 evaluable patients, NUC-1031 monotherapy produced a complete response in 1 patient and a partial response in 2 patients according to the criteria of blinded independent central review. The condition of 16 patients treated with NUC-1031 was stable.
23 patients received 2 or more cycles of NUC-1031 treatment, with a confirmed objective response rate of 13% and a disease control rate of 83%. However, NuCana plc said these are preliminary results and may change in the future.
In Part 2 of the trial, researchers plan to more closely examine the safety, pharmacokinetics, dosing intensity, and clinical activity of NUC-1031 in the expansion cohort. However, NuCana decided not to proceed with Part 2 of the PRO-105 trial. Instead, the company will focus its resources on exploring the drug's use in biliary tract cancer and investigating the efficacy of NUC-3373, a ProTide convert of fluorouracil, in colorectal cancer.
References:
FDA Grants Fast Track Status to NUC-1031 for Biliary Tract Cancer (onclive.com)
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