Duvelisib meets primary endpoint in indolent non–Hodgkin lymphoma

A phase 2 study designed to evaluate the efficacy and safety of duvelisib in patients with refractory indolent non-Hodgkin lymphoma met its primary endpoint of overall response, according to a press release from the drug’s manufacturer.

The 129 patients in the single-arm DYNAMO study received twice-daily 25-mg doses of duvelisib (Infinity Pharmaceuticals), an investigational, oral, dual inhibitor of PI3K-delta and PI3K-gamma.

About two-thirds (n = 83) of study participants had follicular lymphoma, whereas 28 had small lymphocytic lymphoma and 18 had marginal zone lymphoma. All patients progressed on or were refractory to rituximab (Rituxan; Genentech, Biogen) and either chemotherapy or radioimmunotherapy.

Researchers reported an ORR of 46%. All responses were partial responses. Response rates were 41% among those with follicular lymphoma, 68% among those with small lymphocytic lymphoma and 33% among those with marginal zone lymphoma.

Most side effects were reversible and clinically manageable. Grade 3 or higher side effects that occurred in at least 10% of patients included neutropenia (28%), diarrhea (15%), thrombocytopenia (13%) and anemia (12%). Twenty percent of patients also experienced infection.

Infinity officials plan to submit the data for presentation at a future scientific conference.

“While the Dynamo study met its primary endpoint, we hoped that treatment with duvelisib as a monotherapy would have provided a larger clinical benefit for patients with advanced indolent non–Hodgkin lymphoma, a difficult-to-treat disease,” Adelene Perkins, president and CEO of Infinity, said in the press release. “We plan to seek feedback from the FDA to determine our next steps with respect to duvelisib in indolent non–Hodgkin lymphoma.”