Infinity Pharmaceuticals announced its has reached its target enrollment of 300 patients in DUO, a randomized Phase 3 clinical trial evaluating the safety and efficacy of duvelisib in comparison with the standard of treatment, ofatumumab. The study’s primary endpoint is progression free survival (PFS) in patients with refractory chronic lymphocytic leukemia (CLL).
“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,” Julian Adams, PhD, President of Research and Development at Infinity Pharmaceuticals, said in a press release. “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.”
Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase PI3K-delta and PI3K-gamma, two proteins known to support the growth and survival of malignant B cells. Ofatumumab, an anti-CD20 antibody, is already approved by the U.S. Food and Drug Administration for the treatment of CLL, a slowly progressing cancer of the blood and bone marrow.
Infinity has also recently completed enrollment in the DYNAMO trial, a Phase 2 open-label, single-arm, monotherapy analysis of duvelisib in nearly 120 patients with indolent non-Hodgkin lymphoma (iNHL) refractory to rituximab and chemotherapy or radioimmunotherapy. The first data derived from the trial are expected in the third quarter of 2016. The FDA has granted Fast Track designation to duvelisib for the treatment of patients with follicular lymphoma (FL) who have already undergone at least two previous therapies, and for CLL patients who have already received at least one therapy. Fast track designation is awarded to facilitate the development, and expedite the review, of drugs that show promise in treating serious conditions and filling an unmet medical need.
Infinity is currently enrolling patients in:
- CONTEMPO, a phase 1b/2 trial in treatment-naive follicular lymphoma patients;
- SYNCHRONY, a Phase 1b study in CLL refractory or relapsed patients treated with a Bruton’s tyrosine kinease (BTK) inhibitor.
Furthermore, Infinity expects to initiate three other clinical trials:
- BRAVURA, a Phase 3, double-blind, placebo-controlled trial in patients with relapsed iNHL;
- FRESCO, a Phase 2 study in patients with relapsed/refractory (r/r) follicular lymphoma;
- A first trial of duvelisib combined with venetoclax, AbbVie’s first-in-class investigational B-cell lymphoma-2 (BCL-2) selective inhibitor.
Infinity Pharmaceuticals is also planning to initiate patient enrollment in DYNAMO+R, a Phase 3 study in patients previously treated for follicular lymphoma.
To read more about these clinical trials, visit Infinity’s Clinical Trials webpage.