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Infinity (INFI) Completes Enrollment in Phase III DUO Study

Infinity Pharmaceuticals, Inc. 's INFI shares gained 5.3% after the company announced that it has completed the targeted enrollment of 300 patients in the phase III DUO study on duvelisib.

The randomized, monotherapy study is evaluating the safety and efficacy of duvelisib in comparison with Novartis AG's NVS Arzerra (ofatumumab) for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Apart from the DUO study, duvelisib is being evaluated in the phase II DYNAMO study for the treatments of patients with indolent non-Hodgkin lymphoma (iNHL) whose disease is refractory to Rituxan and to either chemotherapy or radioimmunotherapy: and in the phase III DYNAMO+R study in patients with previously treated follicular lymphoma (FL). Patient enrolment in the DYNAMO+R study is ongoing, while top-line data from the DYNAMO study in expected in the third quarter of 2016.

In addition, Infinity Pharma is enrolling patients in two studies on duvelisib including the phase Ib/II CONTEMPO study in treatment-naïve patients with FL and the phase Ib SYNCHRONY study for the treatment of CLL patients whose disease is refractory to or has relapsed while receiving a Bruton's tyrosine kinase (BTK) inhibitor.

Meanwhile, three additional studies on duvelisib are expected to be initiated in by year end. These include the phase III BRAVURA study in patients with relapsed iNHL, the phase II FRESCO study in patients with relapsed/refractory FL, and a study on the candidate in combination with AbbVie Inc.'s ABBV venetoclax.

We note that duvelisib has Fast Track designation in the U.S. for the treatment of patients with FL who have received at least two prior therapies and patient with CLL who have received at least one prior therapy.

Infinity Pharma plans to meet with the FDA to ascertain if BRAVURA can serve as a confirmatory study if DYNAMO supports accelerated approval.

We remind investors that in Sep 2014, Infinity Pharma had entered into a collaboration agreement with AbbVie for worldwide development and commercialization of duvelisib for cancer treatment. The candidate is being jointly developed by both companies.

An approved PI3K inhibitor in the market is Gilead Sciences Inc.'s GILD Zydelig.

Infinity Pharma carries a Zacks Rank #3 (Hold). Gilead is a better-ranked stock in the health care sector, carrying a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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