Duvelisib is an investigational oral drug being developed by Verastem to treat blood cancers such as indolent or slow-growing non-Hodgkin’s lymphoma (NHL) and other T-cell lymphomas.
The U.S. Food and Drug Administration (FDA) granted it fast-track designation on Sept. 6, 2017, to treat people with peripheral T-cell lymphoma (PTCL) who have received at least one prior treatment, follicular lymphoma (FL) who have received at least two prior treatments, and chronic lymphocytic leukemia (CLL) who have had at least one treatment.
How duvelisib works
Duvelisib works by inhibiting two enzymes that help malignant B- and T-cells survive and grow: phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. Researchers believe the link between PI3K enzymes and malignant cells is key to the growth of tumors. Duvelisib weakens B- and T-cells by disrupting tumor cell interactions with their microenvironment.
Duvelisib in clinical trials
The FDA based its fast-track designation on the results of a Phase 1 study that showed a 50 percent overall response rate in 16 patients with relapsed or refractory PTLC who had been submitted to a heavy load of treatments, with three complete responses and five partial responses.
The company plans to start an open-label, multicenter, Phase 2 trial by year’s end that will assess the effectiveness and safety of duvelisib in people with relapsed or refractory PTCL.
There are two ongoing studies: a Phase 3 monotherapy trial called DUO (NCT02004522) in people with relapsed or refractory CLL and small lymphocytic lymphoma (SLL), and a Phase 2 trial called DYNAMO (NCT01882803), in patients with refractory indolent NHL. Both trials have achieved their primary objectives regarding efficacy.
Preliminary results from the DYNAMO trial showed important clinical activity in heavily pretreated and highly refractory participants with indolent NHL, with an acceptable safety profile.
Other details
The main adverse events reported from DYNAMO include low blood-cell count and diarrhea. Most participants were able to remain in the trial.
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