Products

DUVELISIB

Product Profile

Duvelisib is a potent and selective oral small molecule inhibitor of PI3K-δ (delta) and PI3K-γ (gamma). Verastem has COM patent protection of duvelisib through 2030 before extensions, and has received orphan drug designation for duvelisib in FL, CLL, and SLL in the US and EU. The FDA has granted fast track designation to the investigation of duvelisib for the potential treatment of patients with CLL who have received at least one prior therapy, of patients with follicular lymphoma who have received at least two prior therapies, and of patients with PTCL who have received at least one prior therapy.

Clinical Development of Duvelisib

The only dual inhibitor of PI3K-δ,γ with positive Phase 3 results, duvelisib has the potential to be a first-in-class treatment for certain types of hematologic malignancies.

DUO™ is a Phase 3, randomized, open-label, 2-arm trial evaluating the safety and efficacy of duvelisib vs. ofatumumab in 319 patients with relapsed or refractory Chronic Lymphocytic Leukemia (R/R CLL). The DUO™ trial has been completed, and has successfully met its primary endpoint.

The clinical utility of duvelisib in lymphoid malignancies has been previously shown in DYNAMO™, an open-label, single arm trial of in patients with relapsed or refractory indolent Non-Hodgkin's Lymphoma (R/R iNHL), and in a broad Phase 1 trial in B cell and T cell cancers.

Seeing the therapeutic potential of a more integrated approach to hematologic malignancies, we’re working to develop duvelisib into a new and impactful way to address the needs of patients with many blood cancers. Beginning with CLL/SLL and iNHL, we hope our efforts will further expand the range of available treatment options for B-cell malignancies.

Investigator Sponsored Trials (IST)

We are committed to advancing the science and development of our compounds towards improving outcomes for patients with cancer. We welcome collaboration with you and your sponsoring institution towards this shared goal.

To submit a research proposal, please complete and submit the following form to verastem-IST@verastem.com.

Investigator Sponsored Trial Proposal Form