CAMBRIDGE, Mass., Aug. 9, 2016 /PRNewswire/ -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced its second quarter 2016 financial results. Additionally, the company provided an update on its two development programs, duvelisib, an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, and IPI-549, an immuno-oncology development candidate that selectively inhibits PI3K-gamma. Infinity is continuing to explore a broad range of strategic options for duvelisib, including a potential sale of the program. In parallel, the company continues to advance key value drivers for duvelisib. Infinity is also proceeding with its planned development of IPI-549 in multiple solid tumors and evaluating the best path forward for this development candidate.
"Data reported to date have demonstrated that duvelisib could play an important role in the future treatment of patients with hematologic malignancies, particularly for relapsing and/or refractory patients. We are now exploring strategic options for the program that could enable duvelisib to continue to advance toward potential regulatory filings and commercialization," stated Adelene Perkins, president and chief executive officer. "We are also developing IPI-549 and determining the best clinical path forward for this promising immuno-oncology program. The Phase 1 study, which includes evaluation of IPI-549 as a monotherapy and planned evaluation in combination with a checkpoint inhibitor, is progressing well, and new preclinical and clinical data on IPI-549 will be presented at an immuno-oncology conference next month."
Today Infinity also announced that DUO®, a Phase 3, randomized monotherapy study of duvelisib compared to ofatumumab in 319 patients with relapsed or refractory chronic lymphocytic leukemia (CLL), will proceed to its final analysis. The primary endpoint of the study is progression-free survival, and the event that will trigger the final analysis is expected to occur in the fourth quarter of 2016. If the DUO data are positive, Infinity continues to believe that the study could provide the basis for regulatory approval in CLL. Earlier this year, Infinity reported that DYNAMO®, a registration-focused Phase 2 monotherapy study evaluating the efficacy and safety of duvelisib in patients with refractory indolent non-Hodgkin lymphoma (iNHL), met its primary endpoint of overall response rate and that the company intends to seek feedback on these data from the U.S. Food and Drug Administration (FDA). Infinity is continuing to advance activities to enable potential regulatory filings for duvelisib. While exploring the potential sale of the program, Infinity is suspending its prior guidance on the nature and timing of additional duvelisib program updates, including guidance on data from duvelisib registration-focused trials and timing of potential regulatory filings.
Recent developments include the following:
Duvelisib
- Topline data from DYNAMO reported: In June, Infinity announced that DYNAMO, a registration-focused Phase 2 monotherapy study evaluating the efficacy and safety of duvelisib in 129 patients with refractory iNHL, met its primary endpoint of overall response rate. In the study, duvelisib demonstrated an overall response rate (ORR) of 46 percent. The majority of reported side effects were reversible and clinically manageable. Infinity plans to seek feedback from the FDA on these data.
- Data from CONTEMPO presented at EHA: In June, researchers presented preliminary data from CONTEMPO, a Phase 1b/2 clinical study evaluating duvelisib in combination with rituximab or obinutuzumab in treatment-naïve patients with follicular lymphoma, at the 21st Congress of the European Hematology Association (EHA). Duvelisib in combination with Gazyva® (obinutuzumab) demonstrated an overall response rate of 100 percent, including a 33 percent complete response rate among nine patients evaluable for response, and duvelisib in combination with Rituxan® (rituximab) demonstrated an overall response rate of 80 percent, including a 30 percent complete response among 10 patients evaluable for response. The preliminary safety profile of duvelisib in combination with either obinutuzumab or rituximab in treatment-naïve patients with follicular lymphoma was in line with the safety profile of duvelisib as monotherapy. The CONTEMPO study is ongoing having enrolled 55 patients and is now closed to additional patient enrollment.
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