Allos Therapeutics has initiated a Phase 3 clinical trial (PDX-017) evaluating Folotyn (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma (PTCL).
Folotyn, a folate analogue metabolic inhibitor, is approved in the US for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
Earlier this year, Allos reached an agreement with the US Food and Drug Administration (FDA) under its special protocol assessment (SPA) process on the design of the Phase 3 trial.
The randomised, open-label, multicentre, international PDX-017 study will enroll 549 patients to evaluate the safety and efficacy of Folotyn versus observation in patients with previously undiagnosed PTCL who have achieved an objective response following initial treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or a CHOP-like regimen.
The co-primary endpoints of the trial include progression-free survival (PFS) and overall survival (OS).
The company claims that, if successful, the data will support an expanded indication for Folotyn in the US in this patient population and to convert the current accelerated approval for relapsed and refractory PTCL to a full approval.
The data will also support global regulatory submissions for Folotyn for this patient population outside the US.