Second-line treatment with aldoxorubicin prolonged progression-free survival compared with investigator’s choice among patients with relapsed or refractory soft tissue sarcoma, according to a news release from CytRx, the developer of aldoxorubicin.1
The open-label, phase 3 study (ClinicalTrials.gov Identifier: NCT02049905) enrolled 433 patients with metastatic, locally advanced, or unresectable soft tissue sarcoma whose disease progressed on or after at least 1 prior therapy. Participants were randomly assigned to receive aldoxorubicin or investigator’s choice of treatment, which could include dacarbazine, pazopanib, doxorubicin, ifosfamide, or gemcitabine plus docetaxel.
Treatment with aldoxorubicin significantly reduced the risk of progression or death by 38% compared with those given investigator’s choice in the 246 evaluable patients with leiomyosarcoma or liposarcoma (hazard ratio [HR], 0.62; 95% CI, 0.44-0.99; P = .007).
There was no significant difference in progression-free survival between the 2 treatment arms (HR, 0.81; 95% CI, 0.64-1.06; P = .12). Aldoxorubicin was, however, associated with a 29% reduction in the risk for progression or death vs investigator’s choice among the 312 patients treated in North America (HR, 0.71; 95% CI, 0.53-0.97; P = .028).
Aldoxorubicin was associated with an improvement in the disease control rate compared with investigator’s choice in the entire study population (29.4% vs 20.5%; P = .030). Overall survival data are not yet mature.
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Based on these findings, CytRx plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in 2017 for aldoxorubicin as a treatment for patients with relapsed or refractory soft tissue sarcoma.
- CytRx reports statistically significant updated results from pivotal phase 3 trial of aldoxorubicin in patients with second-line soft tissue sarcomas. CytRx website. http://phx.corporate-ir.net/phoenix.zhtml?c=187775&p=irol-newsArticle_print&ID=2226067. Published November 29, 2016. Accessed December 16, 2016.