The expanded analysis focuses on the 61 patients with an AP23573 clinical-benefit response – the primary end-point of the 212-patient trial – and its relation to progression-free survival.
Patients with an AP23573 clinical-benefit response, tumor regression or disease stabilization had a progression-free survival rate (PFS) at six months of 70% and a median PFS of 36 weeks.
The PFS rate in this patient subset was nearly triple that of the overall trial population, and the median PFS was approximately 21 weeks longer than that of the overall trial population.
“The data from the expanded analysis of the phase II trial further support our phase III trial strategy which focuses on advanced sarcoma patients who have experienced a favorable response to prior chemotherapy and have stable disease. We believe this patient population has the greatest likelihood of achieving sustained clinical benefit from treatment with a new molecularly targeted agent such as AP23573,” said Camille Bedrosian, chief medical officer of Ariad.