Log in
Lost password
Become a member for free
Sign up
Sign up
Dynamic quotes 

4-Traders Homepage  >  Equities  >  Nasdaq  >  Gilead Sciences, Inc.    GILD

News SummaryMost relevantAll newsSector news 
The feature you requested does not exist. However, we suggest the following feature:

Gilead Sciences : Zydelig® Combined with Bendamustine and Rituximab Shows Superior Efficacy to Bendamustine/Rituximab in Phase 3 Study of Patients with...

11/25/2015 | 11:24am US/Eastern

Gilead's Zydelig® Combined with Bendamustine and Rituximab Shows Superior Efficacy to Bendamustine/Rituximab in Phase 3 Study of Patients with Relapsed Chronic Lymphocytic Leukemia

By a News Reporter-Staff News Editor at Hematology Week -- Following the recommendation by an independent Data Monitoring Committee (DMC), Gilead Sciences, Inc. (NASDAQ:GILD) announced that its Phase 3 Study 115 evaluating Zydelig® (idelalisib) added to standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early. The DMC recommendation is based upon a predefined interim analysis indicating a statistically significant benefit in efficacy for progression-free survival (PFS) and overall survival (OS) in patients receiving Zydelig plus bendamustine and rituximab, compared to those receiving only bendamustine and rituximab. The safety profile of Zydelig was consistent with prior studies. Detailed results from this study will be presented during a late-breaking abstracts session (#LBA-5) at the Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida taking place December 5-8 (see also Gilead Sciences, Inc.).

Zydelig is approved in the United States in combination with rituximab for patients with relapsed CLL for whom rituximab alone would be considered appropriate therapy due to comorbidities.

"The clinical benefit observed in this Phase 3 study adds to the body of evidence demonstrating the potential of Zydelig-containing treatment regimens for patients with previously treated CLL," said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. "We look forward to sharing the detailed scientific data with the hematology community at the upcoming ASH meeting."

Study 115 is a randomized, double-blind, placebo-controlled, Phase 3 study evaluating the efficacy and safety of Zydelig in combination with bendamustine and rituximab among 416 adult patients with previously treated CLL. Eligible patients were randomized (1:1) to receive six cycles of bendamustine and rituximab over 24 weeks combined with either Zydelig 150 mg or placebo taken orally twice daily continuously until disease progression or unacceptable toxicity. The primary endpoint is PFS.

Additional details contained in the Study 115 abstract are available at https://ash.confex.com/ash/2015/webprogram/start.html. Based on these results, Gilead plans to submit supplemental regulatory filings in the U.S. and Europe early next year.

Keywords for this news article include: Oncology, Hematology, Gilead Sciences Inc., Chronic Lymphocytic Leukemia.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2015, NewsRx LLC

(c) 2015 NewsRx LLC, source Health Newsletters

React to this article
Latest news on GILEAD SCIENCES, INC.
11/25 GILEAD SCIENCES : Zydelig® Combined with Bendamustine and Rituximab Shows Superi..
11/24 GILEAD SCIENCES : to Present at Two Upcoming Investor Conferences on Tuesday, De..
11/23 GILEAD SCIENCES : European Commission Grants Marketing Authorization for Gilead&..
11/19 GILEAD SCIENCES : U.S. FDA Approves New Indications for Harvoni®, Gilead's Once-..
11/19 GILEAD SCIENCES : X-Rx Announces Autotaxin Inhibitor Collaboration with Gilead S..
11/17 European biotech gets boost as Genmab market value hits $7 billion
11/16 GILEAD SCIENCES : Gileand Sciences - Briefing
11/16 GILEAD SCIENCES : Zydelig® Combined with Bendamustine and Rituximab Shows Superi..
11/16 GILEAD SCIENCES : Briefing
11/14 GILEAD SCIENCES : Multiple Scientific Presentations at The Liver Meeting 2015 Fu..
News chart
Full-screen chart
Income Statement Evolution
More Financials