Phase 2 Study of Candidate for Refractory Indolent Non-Hodgkin Lymphoma Patients So-So

Phase 2 Study of Candidate for Refractory Indolent Non-Hodgkin Lymphoma Patients So-So

Infinity Pharmaceuticals recently announced that its Phase 2 clinical trial Dynamo evaluating the efficacy and safety of duvelisib in patients with refractory indolent non-Hodgkin lymphoma (iNHL) met its primary endpoint but with less result than researchers hoped.

“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 a press release. “We plan to seek feedback from the FDA to determine our next steps with respect to duvelisib in indolent non–Hodgkin lymphoma.”

Duvelisib is an investigational dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two molecules that are involved in the growth and survival of malignant B-cells. It is being evaluated in Dynamo and in two Phase 3 trials in patients with follicular lymphoma and relapsed/refractory chronic lymphocytic leukemia.

Dynamo is a single-arm study designed to address the efficacy and safety of a daily dose of duvelisib in 129 patients with iNHL who progressed or were refractory to rituximab and to either chemotherapy or radioimmunotherapy. It included 83 patients with follicular lymphoma, 28 with small lymphocytic lymphoma, and 18 with marginal zone lymphoma.

The study primary endpoint was 46%, with all responses were partial – specifically 41% among patients follicular lymphoma, 68% among subjects with small lymphocytic lymphoma, and 33% for patients with marginal zone lymphoma.

But the study also revealed that duvelisib side effects are mostly reversible and clinically manageable.

Those results may lead duvelisib toward next steps for approval by the Food and Drug Administration (FDA). Infinity is expecting to submit Dynamo data to be presented on a future scientific conference.

NHL is one of the leading new cancer cases that develops from lymphocytes. The most common non-Hodgkin’s lymphoma subtypes include diffuse large B-cell lymphoma and follicular lymphoma, the latter accounting for 22% of all newly diagnosed NHL cases around the world.

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