On June 14, 2016 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that DYNAMO, a registration-focused Phase 2 monotherapy study evaluating the efficacy and safety of duvelisib, an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with refractory indolent non-Hodgkin lymphoma (iNHL) met its primary endpoint of overall response rate (Press release, Infinity Pharmaceuticals, JUN 14, 2016, View Source [SID:1234513312]). In the study, duvelisib demonstrated an overall response rate (ORR) of 46 percent, all of which were partial responses, among 129 patients with iNHL. The majority of reported side effects were reversible and clinically manageable. Schedule your 30 min Free 1stOncology Demo! "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," stated Adelene Perkins, president and chief executive officer at Infinity. "We plan to seek feedback from the U.S. Food and Drug Administration to determine our next steps with respect to duvelisib in indolent non-Hodgkin lymphoma."
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In addition, Infinity and AbbVie are in ongoing, collaborative discussions to explore next steps for the parties’ collaboration. Pending the resolution of these business discussions, AbbVie and Infinity have also agreed to pause the AbbVie-sponsored Phase 1b/2 study evaluating duvelisib in combination with venetoclax.
Infinity is also undertaking a strategic restructuring that will close down its discovery research organization, impacting 46 members of the Infinity team, or 21 percent of the workforce.
"This restructuring is a necessary step to preserve financial resources as we explore options for duvelisib and the advancement of IPI-549, our second clinical program," stated Adelene Perkins, president and chief executive officer. "These were very difficult decisions that were undertaken, and I would like to personally express my deep appreciation to the very talented and dedicated Citizen-Owners impacted by the restructuring for their tremendous contributions to Infinity."
Infinity expects to provide updated 2016 financial guidance following the resolution of these strategic activities. The previous financial guidance for 2016 should no longer be relied upon.
DYNAMO Study Details
DYNAMO, a Phase 2 single-arm study, evaluated the efficacy and safety of duvelisib (25 mg twice daily) as a monotherapy in 129 patients with follicular lymphoma (n = 83), small lymphocytic lymphoma (n = 28) or marginal zone lymphoma (n = 18) whose disease has progressed and who are refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint of the study was overall response rate as assessed by an independent review committee.
In the study, the overall response rate was 46 percent, all of which were partial responses. The overall response rate was 41 percent among patients with follicular lymphoma, 68 percent among patients with small lymphocytic lymphoma and 33 percent among patients with marginal zone lymphoma.
In the overall study population, the majority of side effects were reversible and clinically manageable. The most common ≥ Grade 3 side effects that occurred in at least 10 percent of patients in the study were neutropenia (28 percent), diarrhea (15 percent), thrombocytopenia (13 percent) and anemia (12 percent). Twenty percent of patients experienced ≥ Grade 3 infection.
Infinity expects to submit data from the DYNAMO study for presentation at an upcoming scientific conference.
Conference Call Information
Infinity will host a conference call today, June 14, 2016, at 8:30 a.m. ET to discuss the duvelisib data, the restructuring and other corporate developments. A live webcast of the conference call can be accessed in the Investors/Media section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) and 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 33224813. An archived version of the webcast will be available on Infinity’s website for 30 days.
About NHL
Non-Hodgkin lymphoma (NHL) is the seventh leading site of new cancer cases among men and women.1 Follicular Lymphoma (FL) is the most common indolent (slow growing) form of non-Hodgkin lymphoma (NHL), and accounts for about 22 percent of all newly diagnosed cases of NHL worldwide.1 Follicular lymphoma is considered incurable2, and the majority of FL patients diagnosed and treated will experience a pattern of relapse after sequential treatment regimens.3
About Duvelisib
Duvelisib is an investigational dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins that are known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.4,5,6 AbbVie and Infinity Pharmaceuticals, Inc. are jointly researching and developing duvelisib in various cancer types.
Duvelisib is being evaluated in several studies, including a Phase 3 study in combination with other agents in patients with previously treated follicular lymphoma7 and a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia8. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.