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    Phase III study of NUC-1031+cisplatin vs gemcitabine plus cisplatin for first-line treatment of patients with advanced biliary tract cancer (NuTide:121)

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    Authors
    Knox, J.
    McNamara, Mairead G
    Goyal, L.
    Cosgrove, D.
    Springfeld, C.
    Sjoquist, K.
    Park, J. O.
    Verdaguer, H.
    Braconi, C.
    Ross, P.
    Oh, D. Y.
    De Gramont, A.
    Shroff, R. T.
    Zalcberg, J. R.
    Palmer, D.
    Valle, Juan W
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    Affiliation
    Princess Margaret Cancer Centre, Princess Margaret Cancer Center, Toronto, ON, Canada
    Issue Date
    2021
    
    Metadata
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    Abstract
    Background Biliary tract cancer (BTC) is an aggressive disease with a poor prognosis. Gemcitabine + cisplatin (GemCis) is the accepted global standard of care; however, key cancer resistance mechanisms associated with the transport, activation and breakdown of gemcitabine are known to limit its clinical activity. NUC-1031 is a phosphoramidate transformation of gemcitabine designed to overcome these key resistance mechanisms and generate much higher levels of the active anti-cancer metabolite, dFdCTP, in cells. Promising efficacy has been observed in the phase Ib ABC-08 study of NUC-1031 + cisplatin for first-line treatment of advanced BTC. Of 21 patients (pts) enrolled in 2 dose cohorts (NUC-1031 625 mg/m2 or 725 mg/m2 + cisplatin 25 mg/m2 on Days 1 and 8 of 21-day cycles), 16 were considered to be efficacy evaluable. In this population, 1 pt had a CR and 6 pts had PRs, resulting in an ORR of 44% (7/16). This compares favorably to the 26% ORR reported for GemCis. In addition, 6 pts had SD, resulting in a DCR of 81% (13/16). The combination was well tolerated with no unexpected AEs or DLTs. The recommended dose of NUC-1031 with cisplatin was 725 mg/m2. The encouraging efficacy and tolerability profile led to initiation of a global registrational study. Trial design NuTide:121 is a phase III, open-label, randomised study of NUC-1031 + cisplatin vs GemCis for first-line treatment of advanced BTC. Pts ?18 years with histologically- or cytologically-confirmed BTC (including cholangiocarcinoma, gallbladder, or ampullary cancer), who have had no prior systemic chemotherapy for locally advanced/metastatic disease, are eligible. A total of 828 pts are being randomised (1:1) to either 725 mg/m2 NUC-1031 or 1000 mg/m2 gemcitabine, both with 25 mg/m2 cisplatin, administered on Days 1 and 8 of 21-day cycles. Primary endpoints are OS and ORR. Secondary endpoints include PFS, safety, PK and pt-reported QoL. In addition to the final analysis, three interim analyses are planned. NuTide:121 is being conducted at approximately 125 sites across North America, Europe and Asia Pacific.
    Citation
    Knox J, McNamara MG, Goyal L, Cosgrove D, Springfeld C, Sjoquist K, et al. 59TiP Phase III study of NUC-1031 + cisplatin vs gemcitabine + cisplatin for first-line treatment of patients with advanced biliary tract cancer (NuTide:121). Vol. 32, Annals of Oncology. Elsevier BV; 2021. p. S381.
    Journal
    Annals of Oncology
    URI
    http://hdl.handle.net/10541/624700
    DOI
    10.1016/j.annonc.2021.08.338
    Additional Links
    https://dx.doi.org/10.1016/j.annonc.2021.08.338
    Type
    Other
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.annonc.2021.08.338
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