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CytRx (CYTR) Reports Updated Results from Pivotal Phase 3 Trial of Aldoxorubicin in Patients with Second-Line Soft Tissue Sarcomas

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Additional Relevant Details  The study, which enrolled 433 patients, demonstrated a statistically significant improvement in progression-free survival (PFS) between aldoxorubicin and investigator's choice therapy in 246 patients with leiomyosarcoma and liposarcoma, (p=0.007). The hazard ratio (HR) was 0.62 (95% CI 0.44-0.88), representing a 38% reduction in the risk of tumor progression for patients receiving aldoxorubicin versus investigator's choice. Leiomyosarcoma and liposarcoma are the two most common types of STS and accounted for 57% of the patients enrolled in the trial. Aldoxorubicin demonstrated a statistically significant improvement in PFS over investigator's choice in 312 patients treated in North America (p=0.028; HR=0.71, 95% CI 0.53-0.97). Notably, aldoxorubicin performed better than investigator's choice for the entire study population and narrowly missed statistical significance (p=0.12; HR=0.81, 95% CI 0.64-1.06).  All responses were determined by an independent, blinded central lab assessment of scans.
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Catalyst Date
Occurred on:
Nov 29, 2016
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Related Keywords Phase 3 Trial, Aldoxorubicin, Second-line Soft Tissue Sarcomas, Leiomyosarcoma, Liposarcoma