On November 17, 2015 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported 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) (Press release, Infinity Pharmaceuticals, NOV 17, 2015, View Source [SID:1234508269]). Schedule your 30 min Free 1stOncology Demo! 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.
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"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 View Source 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.