Verastem expanding duvelisib development program after Fast Track designation
Verastem announced the expansion of its duvelisib development program to include targeting the treatment of patients with Peripheral T-Cell Lymphoma. Duvelisib has been granted Fast Track designation by the FDA for the treatment of patients with PTCL who have received at least one prior therapy. Duvelisib, Verastem's lead drug candidate, is an oral inhibitor of phosphoinositide-3-kinase-delta and PI3K-gamma being investigated for the treatment of hematologic cancers, including chronic lymphocytic leukemia/small lymphocytic lymphoma, indolent non-Hodgkin lymphoma and other T cell lymphomas. Development of duvelisib in PTCL is supported by Phase 1 clinical data which demonstrated a 50% investigator-assessed overall response rate in 16 heavily pre-treated patients with relapsed or refractory PTCL. Verastem intends to initiate an open-label, multicenter, Phase 2 clinical trial evaluating the efficacy and safety of duvelisib in patients with relapsed or refractory PTCL by year end 2017. Verastem expects that the Phase 2 study will be conducted in both the U.S. and Japan.