Sarcoma (Pediatric)

July 18, 2016

CytRx issued results of a phase III trial of aldoxorubicin compared to investigator’s choice of therapy in patients with relapsed or refractory soft tissue sarcomas (STS). The randomized, controlled trial enrolled 433 patients at 79 sites in 15 countries. Patients with metastatic, locally advanced or unresectable soft tissue sarcomas who had either not responded to, or who had progressed following treatment with one or more systemic regimens of non-adjuvant chemotherapy, were randomized 1:1 to be treated with aldoxorubicin or the investigator’s choice of an approved chemotherapeutic regimen, including doxorubicin, ifosfamide, dacarbazine, pazopanib (Votrient) or gemcitabine plus docetaxel. The primary endpoint of the study was PFS. Secondary endpoints include overall survival, response rates and safety. The study did not show a significant difference between aldoxorubicin and investigator’s choice of therapy for PFS, with a median of 4.17 months and 4.04 months, respectively, for the study’s primary endpoint (hazard ratio: 0.91). However, the most immediate indications of therapeutic activity, objective response rate (ORR) and disease control rate (ORR + stable disease four months), showed a near doubling in the aldoxorubicin arm compared to investigator’s choice, including in patients who previously received treatment with doxorubicin. Disease control rate for aldoxorubicin was significantly greater than investigator’s choice therapy in the intent-to-treat population (p=0.048) as well as in patients who received prior doxorubicin (p=0.0415). Patients continue to be followed for overall survival (OS), a secondary endpoint of the trial.

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