ZIOPHARM presents positive data from PICASSO Phase II trial for soft tissue sarcoma at 46th ASCO
March 03, 2016
As previously announced, a total of 67 patients with soft tissue sarcoma (STS) were randomized with 66 treated and 62 eligible for evaluation. The study was powered to show a difference in progression free survival (PFS) between doxorubicin in combination with palifosfamide versus doxorubicin alone. The initial analysis demonstrated that the hazard ratio (HR) met the specified endpoint and after consultation with the Data Committee, independent sarcoma experts, and the Medical Advisory Board, enrollment was stopped and results were subsequently reported at the 2009 CTOS Annual Meeting. A second and subsequent analysis was conducted for an end-of-Phase-II meeting with the Food and Drug Administration (FDA) and those data were reported in the recently published ASCO abstract.
The updated study results presented to the FDA reported a hazard ratio of 0.43 favoring the palifosfamide combination with a statistically significant and clinically meaningful 3.4 month difference in median PFS. An analysis of the same data, presented today, consisting of those patients receiving either doxorubicin or doxorubicin in combination with palifosfamide for 6 cycles or less (the standard treatment period for doxorubicin) reported a hazard ratio of 0.39s Syndrome.
"We are very thankful to all who have contributed to the success of the PICASSO study and preparation for the initiation of the Phase III trial (PICASSO III)," added Jonathan Lewis, MD, PhD, of ZIOPHARM.
Source ZIOPHARM Oncology, Inc.