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    A phase I study of ADCT-402 (Loncastuximab Tesirine), a novel pyrrolobenzodiazepine-based antibody-drug conjugate, in relapsed/refractory B-cell Non-Hodgkin lymphoma

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    Authors
    Kahl, BS
    Hamadani, M
    Radford, John A
    Carlo-Stella, C
    Caimi, P
    Reid, E
    Feingold, JM
    Ardeshna, KM
    Solh, M
    Heffner, LT
    Ungar, D
    He, S
    Boni, J
    Havenith, K
    O'Connor, OA
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    Affiliation
    Department of Medicine, Oncology Division, Washington University, St. Louis, Missouri.
    Issue Date
    2019
    
    Metadata
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    Abstract
    PURPOSE: ADCT-402 (loncastuximab tesirine) is an antibody-drug conjugate comprising a CD19-targeting antibody and pyrrolobenzodiazepine dimers. A first-in-human study evaluated the safety and preliminary clinical activity of loncastuximab tesirine in patients with B-cell non-Hodgkin lymphoma (NHL). PATIENTS AND METHODS: A multicenter, phase I, dose-escalation and dose-expansion study enrolled patients ages ?18 years with relapsed/refractory (R/R) B-cell NHL. Patients received loncastuximab tesirine every 3 weeks at doses assigned by a 3+3 dose-escalation design. Dose escalation was used to assess the safety and tolerability of loncastuximab tesirine to determine the dose for expansion. Secondary objectives evaluated clinical activity, characterized the pharmacokinetic profile, and evaluated antidrug antibodies. RESULTS: During dose escalation, 88 patients with R/R B-cell NHL were treated with loncastuximab tesirine at doses 15 to 200 ?g/kg. Treatment-emergent adverse events (TEAEs) were experienced by 87/88 (98.9%) patients. Most common TEAEs (?20% of patients) were hematologic abnormalities, fatigue, edema, liver test abnormalities, nausea, rash, and dyspnea. Grade ?3 TEAEs (?5% of patients) included hematologic abnormalities, liver test abnormalities, fatigue, and dyspnea. Overall response rate at doses ?120 ?g/kg was 59.4% (41 of 69 patients; 40.6% complete response; 18.8% partial response). Median duration of response, progression-free survival, and overall survival (all doses) were 4.8, 5.5, and 11.6 months, respectively. Drug exposure increased with increasing dose, showing moderate accumulation with multiple doses ?150 ?g/kg. There was no evidence of immunogenicity. CONCLUSIONS: Loncastuximab tesirine had promising activity with acceptable safety in this dose-escalation study. A phase II study with initial dosing at 150 ?g/kg has been initiated based on these results.
    Citation
    Kahl BS, Hamadani M, Radford J, Carlo-Stella C, Caimi P, Reid E, et al. A Phase I Study of ADCT-402 (Loncastuximab Tesirine), a Novel Pyrrolobenzodiazepine-Based Antibody-Drug Conjugate, in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma. Clin Cancer Res. 2019;25(23):6986-94.
    Journal
    Clinical Cancer Research
    URI
    http://hdl.handle.net/10541/622559
    DOI
    10.1158/1078-0432.CCR-19-0711
    PubMed ID
    31685491
    Additional Links
    https://dx.doi.org/10.1158/1078-0432.CCR-19-0711
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1158/1078-0432.CCR-19-0711
    Scopus Count
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