Verastem will present long-term findings on duvelisib’s ability to combat non-Hodgkin’s lymphoma at the 14th International Conference on Malignant Lymphoma in Lugano, Switzerland, June 14-17.
Forty-six of 129 lymphoma patients in the DYNAMO Phase 2 clinical trial (NCT01882803) showed a partial response to duvelisib, Verastem’s partner Infinity announced in June 2016. The Lugano presentation will update those results.
Dr. Pier Luigi Zinzani of the University of Bologna Institute of Hematology will deliver the presentation on June 15. It is titled “DYNAMO: A Phase 2 Study Demonstrating the Clinical Activity of Duvelisib in Patients with Double-Refractory Indolent Non-Hodgkin Lymphoma.”
DYNAMO is a single-arm study designed to address the safety and effectiveness of duvelisib as a treatment for indolent non-Hodgkin lymphoma patients who failed to respond to Rituxan (rituximab) and chemotherapy.
Eighty-three of the 129 patients had follicular lymphoma, 28 small lymphocytic lymphoma, and 18 marginal zone lymphoma. They received duvelisib twice a day for up to 13 28-day cycles.
Those who had responded to the treatment after the 13 cycles were allowed to continue receiving it until the disease progressed or there was unacceptable toxicity.
Infinity revealed in June 2016 that the study’s primary goal of a significant patient response to duvelisib had been met. Forty-six percent had partial responses, it said.
The best response rate — 68% — was in patients with small lymphocytic leukemia. Forty-one percent of those with follicular lymphoma responded. The figure was 33 percent for marginal zone lymphoma patients.
Although treatment met the study’s primary objective, the company said it had hoped for better results. None of the patients who responded showed a complete response, for example.
Duvelisib is an investigational dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, 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 of patients with follicular lymphoma and relapsed/refractory chronic lymphocytic leukemia.
“The potential of duvelisib is supported by previously reported clinical data demonstrating anti-cancer activity and a manageable safety profile as an oral monotherapy in a wide range of lymphoid malignancies, including relapsed/refractory iNHL, chronic lymphocytic leukemia (CLL) and T-cell lymphomas,” Dr. Hagop Youssoufian, head of Hematology and Oncology Development at Verastem, said in a press release.
“At Verastem, we are committed to investigating duvelisib’s potential as it may represent a valuable treatment for patients with relapsed/refractory disease who currently have limited treatment options. We look forward to presenting these long-term follow-up data from the DYNAMO study,” he added.