1211A Phase 3, Randomized, Double-Blind, Non-Inferiority Trial to Evaluate Efficacy and Safety of Isavuconazole versus Voriconazole in Patients with Invasive Mold Disease (SECURE): Outcomes in Invasive Aspergillosis Patients
Bibliographic record
Abstract
Background. Isavuconazole (ISA) is a novel, water-soluble, broad-spectrum triazole antifungal available in IV and oral formulations for treatment of invasive fungal disease. A Phase 3 trial (NCT00412893) assessed the efficacy and safety of ISA vs. voriconazole (VRC) in patients with invasive mold disease (IMD). Here we report on a pre-specified subset of patients from this trial who had proven/probable invasive aspergillosis (IA) (EORTC/MSG criteria) and received ≥1 dose of the study drug. Methods. Patients were randomized 1:1 to receive ISA or VRC for up to 84 days. Dosing regimens were: ISA 200mg IV TID for 2 days, followed by 200mg QD (IV or PO); VRC 6mg/kg IV BID on Day 1, 4mg/kg IV BID on Day 2, then either 4mg/kg IV BID or 200mg PO BID. The primary efficacy endpoint was all-cause mortality (ACM) through Day 42. Overall success at end of treatment (EOT) and safety were also assessed. All diagnoses and outcomes were assessed by an independent, blinded, data-review committee. Safety data are presented as reported by the Investigator. Results. Overall 231 patients were included in this analysis (ISA n = 123; VRC n = 108). Patient characteristics, efficacy, and safety outcomes are shown in the table. Differences in drug-related AEs between ISA and VRC were statistically significant (p < 0.001). Patient characteristics and outcomes Conclusion. In patients with documented IA, ISA had comparable efficacy to VRC, but was better tolerated than the latter. Disclosures. D. Kontoyiannis, Merck, Inc.: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium; Astellas: Data review committee lead and Investigator, Compensaiton of data review committee involvement and Research grant; Pfizer: Investigator and Speaker's Bureau, Research grant and Speaker honorarium M. Lee, Astellas: Employee, Salary M. Nucci, Pfizer: Grant Investigator, Scientific Advisor and Speaker's Bureau, Consulting fee, Research grant and Speaker honorarium Astellas: Scientific Advisor, Consulting fee I. Raad, Astellas: Grant Investigator, Grant recipient; Pfizer: Consultant, Consulting fee E. Bow, Astellas: Scientific Advisor, Consulting fee Pfizer: Investigator and Scientific Advisor, Consulting fee and Research grant V. A. Morrison, Astellas: Adjucation committee member, Consulting fee J. Baddley, Astellas: Consultant, Consulting fee; Merck: Consultant, Consulting fee; Pfizer: Consultant, Consulting fee B. Zeiher, Astellas: Employee, Salary R. Maher, Astellas: Employee, Salary W. Huang, Astellas: Employee, Salary K. A. Marr, Astellas: Consultant and Scientific Advisor, Consulting fee; Merck: Consultant, Consulting fee; Pfizer: Consultant, Consulting fee
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".