CytRx's aldoxorubicin misses OS endpoint in Phase III to treat STS

CytRx Corp. (NASDAQ:CYTR) reported additional data from a Phase III trial in 433 patients with metastatic, locally advanced or unresectable soft tissue sarcoma (STS) showing that 350 mg/m² IV aldoxorubicin on day 1 of each 21-day cycle missed the secondary endpoint of improving median overall survival (OS) vs. investigator’s choice of chemotherapy (doxorubicin, ifosfamide, dacarbazine, Votrient pazopanib or gemcitabine plus docetaxel) (12.88 vs. 12.16 months, p=0.8555). Aldoxorubicin also missed the secondary endpoint of improving overall response rate (ORR) vs. chemotherapy (8.3% vs. 4.2%, p=0.1106). Progression-free survival (PFS) rates at 4 and 6 months were 40.8% and 24.8%, respectively, for aldoxorubicin vs. 31.6% and 14.9% for chemotherapy. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

The open-label, international trial enrolled patients who had either not responded to or who had progressed following treatment with ≥1 systemic regimen of non-adjuvant chemotherapy. CytRx previously reported that aldoxorubicin missed the primary endpoint of improving median PFS vs. chemotherapy (4.11 vs. 2.96 months, p=0.087) (see BioCentury, Aug. 1, 2016 & Jan. 9, 2017). In a subgroup of patients with leiomyosarcoma and liposarcoma (n=246), aldoxorubicin significantly improved median PFS vs. chemotherapy (5.32 vs. 2.96 months, p=0.007)...