Gilead Sciences, Inc. GILD announced positive data from a prespecified interim analysis of a phase III study (Study 115) evaluating Zydelig in combination with standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients.
In the study, a 67% reduction in the risk of disease progression or death (progression-free survival) was observed in patients receiving Zydelig in addition to Treanda (bendamustine) and Rituxan (rituximab) compared to those receiving only Treanda and Rituxan. Additionally, the Zydelig arm met all secondary endpoints, including overall survival.
We remind investors that earlier this year, the phase III study was unblinded early based on a recommendation from an independent Data Monitoring Committee.
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 a 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 last month, 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 confirmed 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 Anika Therapeutics Inc. ANIK and Baxalta Incorporated BXLT. Both companies sport a Zacks Rank #1 (Strong Buy).
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