Ariad says AP23573 extended disease stability, was well tolerated in sarcoma trial

New York, June 5 - Ariad Pharmaceuticals, Inc. announced that AP23573 doubled the time in which the disease was stable and was well tolerated in a phase 2 trial in metastatic and/or unresectable soft-tissue and bone sarcomas.

The primary end point of the trial - evidenced by clinical-benefit response rates - was achieved in the three most prevalent types of sarcoma - bone sarcoma, leiomyosarcoma and liposarcoma. Treatment with AP23573 more than doubled progression-free survival when compared to historical control data published by the European Organization for Research and Treatment of Cancer.

The research, presented at the annual meeting of the American Society of Clinical Oncology in Atlanta, included 212 patients, at least 90% of whom had progressive disease.

The clinical-benefit response rate for the overall trial was 29%, with rates not statistically different among the four sub-groups - bone at 30%, leiomyosarcoma at 33%, liposarcoma at 30% and others at 23%.

The primary end point of the trial was achieved for the three most prevalent types of advanced sarcomas.

Progression-free survival rate at six months for the overall trial was 24% and the rates were not statistically different between the bone and soft-tissue sarcoma sub-groups at 25% versus 23% or among the four sub-groups.

The median progression-free survival for the overall trial was 15 weeks, with no statistically significant differences among the four sub-groups.

Treatment with AP23573 more than doubled progression-free survival when compared to historical control data with a median of 15 weeks compared to seven weeks. The progression-free survival rate was 23% versus 8%.

Side effects were generally mild or moderate and reversible, with the most common being mouth sores, fatigue, increased triglycerides, low red blood cell count and nausea.

Based on ongoing discussions with the Food and Drug Administration and the European Medicines Agency, Ariad now plans to conduct a randomized, worldwide phase 3 clinical trial of oral AP23573 in patients with advanced sarcomas.

As in the phase 2 trial, eligible patients will have a broad range of metastatic and/or unresectable soft-tissue and bone sarcomas. However, patients enrolled in the pivotal trial will have at least stable disease following a favorable response to chemotherapy.

The goals of the trial will be to prolong progression-free and overall survival for these patients.

AP23573 has received both fast track designation and orphan drug status from the FDA.

Located in Cambridge, Mass., Ariad develops medicines to treat cancer by regulating cell signaling with small molecules.

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