MediMedia Managed Markets
Managed Care magazine
P&T Community, The Online Resource for P&T Decision Makers
Login / Register
Join Us  Facebook  Twitter  Linked In


News Categories




Positive Results Reported for Aldoxorubicin in Sarcoma Patients

Phase II trial shows drug's superiority over doxorubicin (December 11)

Positive efficacy results have been reported from a randomized, open-label phase IIb clinical trial. The study compared the efficacy and safety of aldoxorubicin with that of doxorubicin in patients with first-line metastatic, locally advanced or unresectable soft-tissue sarcoma (STS).

According to the drug’s developer (CytRx Corporation), aldoxorubicin combines the chemotherapeutic agent doxorubicin with a linker molecule that binds specifically to albumin in the blood to allow the delivery of higher amounts of doxorubicin (3.5 to 4 times) without the major dose-limiting toxicities seen with doxorubicin alone.

In the global clinical trial, 123 patients with advanced STS were randomly assigned to receive either aldoxorubicin 350 mg/m2 (n = 83) or doxorubicin 75 mg/m2 (n = 40) every 3 weeks for up to six cycles. The patients were followed every 6 weeks with computed tomography (CT) scans to monitor tumor size. The study’s primary endpoint was progression-free survival (PFS).

Investigators’ assessments and a central laboratory review showed an 80% to 100% improvement in PFS among patients treated with aldoxorubicin compared with doxorubicin. In an intent-to-treat analysis, the investigator-assessed median PFS was 8.4 months for the aldoxorubicin group versus 4.7 months for the doxorubicin group (P = 0.0002), whereas the blinded central laboratory review indicated that the median PFS in patients treated with aldoxorubicin was 5.7 months compared with 2.8 months in patients treated with doxorubicin (P = 0.018).

The overall response rate, as determined by the investigators, was 25.4% for aldoxorubicin-treated patients (2.7% complete response and 22.7% partial response) compared with 5.4% for doxorubicin-treated patients (0% complete response and 5.4% partial response). As assessed by the blinded central laboratory review, 23.0% of aldoxorubicin-treated patients showed a partial response compared with 0% of the doxorubicin-treated patients.

Source: CytRx Corporation; December 11, 2013.

More stories