Treatment with a new targeted therapy, duvelisib, has shown sustained efficacy and safety in a trial with indolent non-Hodgkin’s lymphoma (iNHL) patients who had not responded well to rituximab and chemotherapy or radioimmunotherapy.
Findings from the phase 2 trial, “DYNAMO: A Phase 2 Study Demonstrating the Clinical Activity of Duvelisib in Patients with Double-Refractory Indolent Non-Hodgkin Lymphoma”, were presented at the 14th International Conference on Malignant Lymphoma (ICML) held June 14-17 in Lugano, Switzerland.
Duvelisib is an experimental drug that inhibits both the PI3K-delta and PI3K-gamma proteins, which are involved in various blood cancers including iNHL, chronic lymphocytic leukemia and T-cell lymphoma.
The Phase 2 DYNAMO trial evaluated the safety and efficacy of duvelisib in 129 patients with double-refractory iNHL, including follicular lymphoma (83 patients), small lymphocytic lymphoma (28 patients) and marginal zone lymphoma (18 patients). Patients had received a median of three prior regimens before enrolling in the trial.
In this group of patients, 47 percent (61 patients) responded to treatment. Importantly, 88 percent of duvelisib-treated patients experienced a decrease in the size of their target lymph nodes. Their median duration of response was 10 months, median time to disease progression was nine months, and median overall survival was 27.8 months.
During a median follow-up of 18 months, duvelisib was considered safe and manageable. The most common severe side effects were low levels of neutrophils, a type of immune cells, and platelets, anemia and diarrhea. Patients also reported infections of all types and severity (56 percent).
These results suggest duvelisib has favorable benefit-risk in double-refractory iNHL, and may provide an important new treatment option for a population in need of new targeted therapies.