ZIOPHARM Oncology, Inc. (ZIOP) announced positive preliminary overall survival, or OS, data from its randomized, controlled Phase 2 trial of palifosfamide plus doxorubicin versus doxorubicin alone, or PICASSO, in patients with unresectable or metastatic soft tissue sarcoma.
An analysis of the OS data conducted according to the statistical analysis plan, with greater than 70% of events occurring and follow-up of 33 months, showed a meaningfully positive trend favoring the palifosfamide arm. This well-controlled trial is demonstrating longer than expected survival in a difficult to treat population, the company noted.
ZIOPHARM stated that at 2-years after starting treatment, around 40% of subjects treated with palifosfamide are alive and 30% in the control arm treated with doxorubicin are alive, compared to an expected 25% based on randomized data.
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