Ariad reaches agreement with FDA for Phase III cancer drug trial

Based on the assessment, progression-free survival (PFS) will be the primary endpoint of the Phase III trial and overall survival will be a secondary endpoint. The company expects to begin patient enrollment in the trial later in September.

The special protocol assessment (SPA) is a written agreement between the trial's sponsor and the FDA regarding the design, endpoints, and planned conduct and analysis of a trial to be used in support of regulatory approval.

The European Medicines Agency (EMEA) has provided protocol advice consistent with that of the FDA regarding the Phase III trial design as part of its protocol assistance program. Ariad and Merck & Co. have a global collaboration to jointly develop and commercialize deforolimus for use in cancer.

Ariad and Merck plan to conduct a Phase III trial of oral deforolimus in patients with metastatic soft tissue and bone sarcomas following a favorable response to chemotherapy – a period when continued treatment with traditional chemotherapeutic agents has not been established to provide additional clinical benefit.

This double-blind trial is designed to evaluate approximately 650 patients who will be randomized (1:1) to oral deforolimus or placebo at approximately 125 sites. Complete patient enrollment and the second interim analysis are expected to take place within approximately two years of the first patient being enrolled.

Pierre Dodion, senior vice president of oncology at Araid, said: “FDA agreement on our overall Phase III trial design, patient population and endpoints, as well as our newly established partnership with Merck represent important achievements for the global development of deforolimus.”