Program Schedule

824
An Open-Label Phase 3 Study of Isavuconazole (VITAL): Focus on Mucormycosis

Session: Poster Abstract Session: Clinical - Clinical Trials
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • FMarty 824_VITAL Mucor poster.pdf (158.3 kB)
  • Background: Isavuconazole (ISA) is a novel, broad-spectrum triazole antifungal, available as a water-soluble prodrug in IV and oral formulations, for the treatment of invasive fungal disease (IFD). The objective of this analysis is to report the overall response, survival, and safety in a subset of patients with invasive mucormycosis (IM) who were treated with ISA.

    Methods: VITAL was a Phase III, multicenter, open-label trial conducted to evaluate safety and efficacy of ISA treatment in patients with rare IFD. Eligibility criteria and evaluated outcomes are outlined in clinicaltrials.gov, NCT00634049. Patients received IV or PO ISA 200 mg TID for 2 days followed by 200 mg/day until day 180, end of treatment (EOT). An independent data review committee (DRC) categorized patients as having proven or probable IFD by EORTC/MSG criteria. DRC-assessed overall response at EOT, survival, and adverse events (AEs) using standard definitions are reported for patients with proven/probable IM.

    Results: Overall 37 patients with IM received ISA for a median of 84 days (range 2–882). Baseline demographics, study outcomes, and survival are shown in Table 1. Survival at 180 days was 53%. Overall 95% of patients experienced an AE, 76% experienced a serious AE (SAE). Only 3 (8%) SAEs were attributed to ISA.

    Table 1. Baseline demographics, study outcomes, and survival

    Parameter

    All patients   (N=37)

    Baseline characteristics

     

        Age (years), median (range)

    50 (22–79)

        Male, n (%)

    30 (81)

    Primary underlying condition, n (%)

     

        Hematological malignancy

    22 (60)

        Allogeneic bone marrow transplant

    13 (35)

        Diabetes mellitus

    3 (8)

    Immune status n, (%)

     

        Neutropenic

    10 (27)

        Corticosteroid use

    10 (27)

        T-cell immunosuppressant use

    18 (49)

    Organ involvement

     

        Pulmonary

    22 (59)

        Sinus

    16 (43)

        Central nervous system

    6 (16)

        Skin

    2 (5)

        Bone

    5 (14)

        Disseminated

    11 (30)

    Efficacy

     

    Overall Response at EOT, n (%)

     

        Complete

    5 (14)

        Partial

    6 (16)

        Stable

    10 (27)

        Progression

    14 (38)

        Missinga

    2 (5)

    Survival rateb, % (95% CI)

     

        Day 42

    65 (47, 78)

        Day 84

    59 (42, 73)

        Day 120

    56 (39, 71)

        Day 180

    53 (35, 68)

    aTwo people continued treatment at EOT cutoff

    bKaplan–Meier method

    Conclusion: ISA appears to be a safe and promising agent for the treatment of mucormycosis in a particularly high-risk immunocompromised population.

    Francisco M. Marty1, John R. Perfect2, Oliver a. Cornely3, Kathleen M. Mullane4, Galia Rahav5, Misun Lee6, Masanori Ito6, Rochelle Maher6, Bernhardt Zeiher6 and Luis Ostrosky-Zeichner7, (1)Brigham and Women's Hospital, Boston, MA, (2)Duke University, Durham, NC, (3)University Hospital of Cologne, Koeln, Germany, (4)University of Chicago Medicine, Chicago, IL, (5)Sheba Medical Center, Tel Hashomer, Israel, (6)Astellas Pharma Global Development, Northbrook, IL, (7)University of Texas, Houston, TX

    Disclosures:

    F. M. Marty, Astellas: Grant Investigator, Research support
    Chimerix: Grant Investigator, Research support
    Merck: Consultant, Consulting fee
    Vertex: Consultant, Consulting fee
    WHISCON: Grant Investigator, Research support
    Alexion: Consultant, Consulting fee
    Gilead: Consultant, Consulting fee
    ViroPharma: Grant Investigator, Research support
    GlaxoSmithKline: Grant Investigator, Research support

    J. R. Perfect, Astellas: Grant Investigator and Scientific Advisor, Consulting fee
    Merck: Investigator, Grant recipient
    F2G: Scientific Advisor, Consulting fee
    Scynerxis: Scientific Advisor, Consulting fee
    Viamet: Scientific Advisor, Consulting fee

    O. A. Cornely, German Federal Ministry of Research and Education (BMBF grant 01KN1106): Grant Investigator, Grant recipient
    European Commission: Grant Investigator, Grant recipient
    Astellas: Investigator, Scientific Advisor and Speaker's Bureau, Consulting fee, Research grant and Speaker honorarium
    Gilead: Investigator, Scientific Advisor and Speaker's Bureau, Consulting fee and Research grant
    Merck/MSD: Investigator, Scientific Advisor and Speaker's Bureau, Consulting fee, Research grant and Speaker honorarium
    Pfizer: Investigator, Scientific Advisor and Speaker's Bureau, Consulting fee, Research grant and Speaker honorarium
    3M: Consultant and Investigator, Consulting fee and Research grant
    Cubist: Consultant and Investigator, Consulting fee and Research grant
    Basilea: Consultant and Investigator, Consulting fee and Research grant
    F2G: Consultant and Investigator, Consulting fee and Research grant
    GSK: Consultant and Investigator, Consulting fee and Research grant
    Optimer: Consultant and Investigator, Consulting fee and Research grant
    Actelion: Investigator, Research grant
    Sanofi Pasteur: Consultant, Consulting fee
    Quintiles: Investigator, Research grant
    Summit/Vifor: Consultant, Consulting fee
    Viropharma: Investigator, Research grant
    Celgene: Investigator, Research grant
    Genzyme: Investigator, Research grant
    Miltenyi: Investigator, Research grant

    K. M. Mullane, Astellas: Research Contractor and Speaker's Bureau, Research support
    Anson Pharmaceuticals: Research Contractor, Research support
    Chimerix: Research Contractor and Scientific Advisor, Research support
    Cubist / optimer: Research Contractor, Scientific Advisor and Speaker's Bureau, Consulting fee, Research support and Speaker honorarium
    Merck sharp and Dolme Corp: Research Contractor and Scientific Advisor, Consulting fee and Research support
    Rebiotix: Research Contractor, Research support
    Viropharma: Research Contractor, Research support
    Pfizer: Research Contractor, Research support

    G. Rahav, Astellas: Grant Investigator and Scientific Advisor, Consulting fee and Research grant
    MSD: Consultant, Grant Investigator and Scientific Advisor, Consulting fee, Research grant and Speaker honorarium

    M. Lee, Astellas: Employee, Salary

    M. Ito, Astellas: Employee, Salary

    R. Maher, Astellas Pharma Global Development: Employee, Salary

    B. Zeiher, Astellas: Employee, Salary

    L. Ostrosky-Zeichner, Merck: Consultant, Grant Investigator and Non-branded educational speaking, Consulting fee, Research grant and Speaker honorarium
    Pfizer: Grant Investigator and Non-branded educational speaking, Research grant and Speaker honorarium
    Astellas: Consultant, Grant Investigator, Non-branded educational speaking and Scientific Advisor, Consulting fee, Research grant and Speaker honorarium
    T2 Biosystems: Grant Investigator, Research grant

    Findings in the abstracts are embargoed until 12:01 a.m. EDT, Oct. 8th with the exception of research findings presented at the IDWeek press conferences.

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