Infinity Announces Completion Of Target Enrollment In DUO™, A Phase 3 Study Evaluating Duvelisib In Chronic Lymphocytic Leukemia

17 Nov, 2015, 08:00 ET from Infinity Pharmaceuticals, Inc.

CAMBRIDGE, Mass., Nov. 17, 2015 /PRNewswire/ -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that it has reached target enrollment of 300 patients in DUO, a randomized Phase 3 monotherapy study evaluating the safety and efficacy of duvelisib compared to ofatumumab (an anti-CD20 antibody) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The primary endpoint of this study is progression free survival (PFS). Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. Infinity is jointly developing duvelisib with AbbVie, its strategic development and commercialization partner for duvelisib in oncology.

"Reaching this enrollment milestone for DUO is an important achievement for Infinity and the duvelisib development program. We are grateful for the support of the DUO investigators, and most importantly the patients and their families, for their participation in this study. We would also like to thank the Infinity and AbbVie teams for their hard work in ensuring completion of enrollment in this trial," said Julian Adams, Ph.D., president, research and development at Infinity. "This achievement follows the recent completion of patient enrollment in DYNAMO, our registration-focused study of duvelisib in indolent non-Hodgkin lymphoma. We look forward to seeing the data from both of these studies, which could enable us to move forward with global regulatory filings."

Infinity recently completed patient enrollment in DYNAMO, a global, Phase 2 open-label, single-arm, monotherapy study of duvelisib in approximately 120 patients with indolent non-Hodgkin lymphoma (iNHL) whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint of the study is overall response rate. Topline data from the study are anticipated in the third quarter of 2016. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to duvelisib for both the treatment of patients with follicular lymphoma (FL), the most common form of iNHL, who have received at least two prior therapies and for the treatment of patients with CLL who have received at least one prior therapy.

The DYNAMO and DUO studies are part of DUETTS, a broad clinical development program evaluating duvelisib in patients with iNHL and CLL. In addition to DYNAMO and DUO, Infinity is enrolling patients in CONTEMPO, a Phase 1b/2 study in treatment-naïve patients with follicular lymphoma, and SYNCHRONY, a Phase 1b study in CLL patients whose disease is refractory to or has relapsed while receiving a Bruton's tyrosine kinase (BTK) inhibitor. Infinity expects three additional clinical studies to be initiated this year: BRAVURA, a Phase 3, double-blind, placebo-controlled study in patients with relapsed iNHL; FRESCO, a Phase 2 study in patients with relapsed/refractory follicular lymphoma; and the first clinical study of duvelisib in combination with venetoclax, AbbVie's first-in-class investigational B-cell lymphoma-2 (BCL-2) selective inhibitor. Infinity is planning to close enrollment in DYNAMO+R, a Phase 3 study in patients with previously treated follicular lymphoma and is planning to meet with the FDA to ascertain that BRAVURA can serve as a confirmatory study if DYNAMO supports an accelerated approval.

Additional information on clinical studies of duvelisib is available at http://www.infi.com/research-development/clinical-trials/ or at www.clinicaltrials.gov.

About Duvelisib Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins with predominantly non-overlapping roles known to support the growth and survival of malignant B-cells.[i] Preclinical data suggest that PI3K-delta signaling can lead to the proliferation of malignant B-cells, and both PI3K-gamma and PI3K-delta play a role in the formation and maintenance of the supportive tumor microenvironment.[ii] Duvelisib is the only investigational PI3K-delta,gamma inhibitor in Phase 3 clinical development and has the potential to be a first-in-class treatment for certain types of hematologic malignancies, or blood cancers. AbbVie and Infinity Pharmaceuticals, Inc. are jointly developing duvelisib in oncology.

Duvelisib is being evaluated in registration-focused studies, including DYNAMO, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma, and DUO, a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

About Infinity Pharmaceuticals, Inc. Infinity is an innovative biopharmaceutical company dedicated to discovering, developing and delivering best-in-class medicines to people with difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. For more information on Infinity, please refer to the company's website at www.infi.com.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the company's expectations about: plans to initiate additional duvelisib studies in 2015; seeking regulatory approval for duvelisib; plans to request FDA advice regarding BRAVURA; the therapeutic potential of PI3K inhibition and duvelisib; the timing and type of plans to present or publish data; and its ability to execute on its strategic plans. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. For example, there can be no guarantee that Infinity will report data, complete enrollment, or initiate clinical studies in the time frames it has estimated, that any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases, or that development of any of Infinity's product candidates will continue. Further, there can be no guarantee that Infinity's strategic collaboration with AbbVie will continue or that any positive developments in Infinity's product portfolio will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Infinity's results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; a failure of Infinity and/or AbbVie to fully perform under the strategic collaboration and/or an early termination of the collaboration and license agreement; the content and timing of decisions made by the U.S. FDA and other regulatory authorities; Infinity's ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of agents by Infinity's competitors for diseases in which Infinity is currently developing or intends to develop its product candidates; and Infinity's ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" included in Infinity's quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 5, 2015, and other filings filed by Infinity with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

[i] Winkler D.G., Faia K.L., DiNitto J.P. et al. (2013) PI3K-d and PI3K-g inhibition by IPI_145 abrogates immune responses and suppresses activity in autoimmune and inflammatory disease models. Chem Biol 20: 1-11. [ii] Peluso M., Faia K.L., Winkler D.G. et al. Duvelisib (IPI-145) Inhibits Malignant B-cell Proliferation and Disrupts Signaling from the Tumor Microenvironment through Mechanisms That Are Dependent on PI3K-d and PI3K-g. Blood (ASH Annual Meeting Abstracts) 2014: Abstract 328.

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SOURCE Infinity Pharmaceuticals, Inc.



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