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Roche's Gazyva Fails in Phase III B-cell Lymphoma Study

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Roche Holding AG (RHHBY - Free Report) announced disappointing results from the phase III study, GOYA, on Gazyva for previously untreated diffuse large B-cell lymphoma (DLBCL).

The global phase III, open-label, multicenter, randomized, two-arm study examined the efficacy and safety of the combination of Gazyva and CHOP chemotherapy (G-CHOP) against Rituxan plus CHOP chemotherapy (R-CHOP).

The trial failed to meet the primary endpoint of a reduction in the risk of disease worsening or death (progression-free survival) compared to Rituxan plus R-CHOP. Adverse events were consistent in both arms.

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The results were a setback for the company as previous trials had showed that Gazyva helped people with previously untreated follicular lymphoma or chronic lymphocytic leukemia live longer without their disease worsening, compared to Rituxan, when combined with chemotherapy.

Results were disappointing also because DLBCL is the most common subtype of non-Hodgkin lymphoma (NHL).

Gazyva is already approved in combination with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia. In Feb 2016, the FDA expanded the label of Gazyva in combination with bendamustine followed by Gazyva alone to include the treatment of follicular lymphoma in patients who did not respond to a Rituxan-containing regimen, or whose follicular lymphoma returned after such a treatment. Last month, it was approved as Gazyvaro in the EU for the same indication.

Roche’s hematology portfolio boasts approved drugs like MabThera/Rituxan, Gazyva/Gazyvaro, Tecentriq (atezolizumab) and Venclexta, as well as an encouraging pipeline comprising candidates like polatuzumab vedotin/RG7596 and a small-molecule antagonist of MDM2 (idasanutlin/RG7388).

Roche currently carries a Zacks Rank #2 (Buy). Other favorably placed stocks in the healthcare sector include Pfizer, Inc. (PFE - Free Report) , Johnson & Johnson (JNJ - Free Report) and Gilead Sciences (GILD - Free Report) . Each of these stocks carries the same rank as Roche.

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