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Gilead's Leukemia Study Unblinded Early on Positive Data

Gilead Sciences, Inc.GILD announced that the phase III study (Study 115) evaluating Zydelig in combination with standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early based on an independent Data Monitoring Committee (DMC) recommendation.

The DMC recommendation followed a predefined interim analysis that indicated a statistically significant benefit in efficacy for progression-free survival and overall survival in patients receiving Zydelig in addition to Treanda (bendamustine) and Rituxan (rituximab) compared to those receiving only Treanda and Rituxan. The safety profile of Zydelig was in line with that observed in prior studies. Detailed data from this study will be presented at the annual meeting of the American Society of Hematology in December.

We note that Zydelig is already approved in the U.S. in combination with Rituxan for patients with relapsed CLL for whom Rituxan alone would be considered appropriate therapy due to comorbidities. Zydelig is also approved as monotherapy for treating patients with relapsed follicular B-cell non-Hodgkin lymphoma and small lymphocytic lymphoma in patients who have received at least two previous systemic therapies. For the first nine months of 2015, Zydelig generated revenues of $92 million. Label expansion of the product could further boost sales.

However, several companies are looking for similar label expansions for their leukemia drugs. We remind investors that earlier this week, AbbVie Inc. ABBV submitted a regulatory application to the FDA for labeling considerations based on safety and efficacy results from the phase III HELIOS (CLL3001) study on Imbruvica. Data from the study confirm Imbruvica's ability to attain enhanced effectiveness when added to the Treanda/Rituxan combination for the treatment of relapsed or refractory patients with CLL or small lymphocytic lymphoma.

Gilead carries a Zacks Rank #2 (Buy). A couple of other favorably ranked stocks in the health care sector are GW Pharmaceuticals plc GWPH and Conatus Pharmaceuticals Inc. CNAT . While GW Pharma sports a Zacks Rank #1 (Strong Buy), Conatus holds a Zacks Rank #2.

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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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