Aldoxorubicin: Additional Phase IIb data
Additional data from an open-label, international Phase IIb trial in 123 patients with STS showed that first-line treatment with 350 mg/m 2 IV aldoxorubicin on day 1 of each 21-day cycle led to a median OS of 16 months vs. 14.4 months for doxorubicin (HR=0.73, 95% CI: 0.44, 1.20, p=0.21). CytRx said patients receiving aldoxorubicin had a 41% likelihood of surviving >2 years vs. 20% for doxorubicin. The company said the final OS results were part of a prospectively planned secondary endpoint analysis and were not powered for significance. The trial enrolled patients with metastatic, locally advanced or unresectable STS who have not been previously treated with chemotherapy. CytRx previously reported ORR and PFS data from the trial (see BioCentury, Oct. 14, 2013 & Dec. 16, 2013). ...