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Genentech’s Gazyva Meets Primary Endpoint Early in Late-Stage Study

Written by: | | Dated: Friday, May 27th, 2016

Genentech’s Gazyva Meets Primary Endpoint Early in Late-Stage Study
May 27, 2016
By Alex Keown, Breaking News Staff


SOUTH SAN FRANCISCO, Calif. – Interim data from a late stage trial shows Genentech (RHHBY)’s Gazyva for the treatment of untreated follicular lymphoma showed a significant difference in the staving off death or reducing the risk of disease progression when compared to Rituxan.

Full trial data will be released later this year, but so far it looks like Genentech, a division of Roche (RHHBY), will have another weapon in its pipeline for the treatment of the most common type of indolent non-Hodgkin’s lymphoma. Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body’s immune system. Genentech said it plans to submit the drug to worldwide regulatory agencies for approval, but did not provide an estimated timeline for that.

Sandra Horning, Genentech’s chief medical officer and head of global product development, touted the success of the therapy option and said this will provide greater treatment for patients with the incurable disease. Follicular lymphoma is considered incurable and relapse is common. In the United States, it is estimated that more than 14,000 new cases of follicular lymphoma will be diagnosed in 2016.

“People with follicular lymphoma continue to need better initial treatment options because their disease is incurable and becomes more difficult to treat with each relapse,” Horning said in a statement.

Genentech’s Gallium study compared the combination treatment of Gazyva plus chemotherapy drug, bendamustine, as well as Gazyva alone against the venerable Rituxan. The trial included 1,401 patients with previously untreated indolent non-Hodgkin’s lymphoma, of which 1,202 patients had follicular lymphoma. The primary endpoint of the study was investigator-assessed progression-free survival (PFS) in patients with follicular lymphoma, with secondary endpoints including PFS assessed by independent review committee (IRC), PFS in the overall study population (iNHL), response rate (overall response, ORR; and complete response, CR), overall survival (OS), disease-free survival (DFS) and safety. Adverse events observed were consistent with previous clinical studies, Genentech said.

Genentech said the interim results from the trial are important “because better initial treatment options delay this incurable disease from progressing and follicular lymphoma becomes more difficult to treat each time the disease returns.” Recently, the FDA also approved Gazyva in combination with bendamustine followed by Gazyva alone as a treatment for people with follicular lymphoma who did not respond to a Rituxan-containing regimen, or whose follicular lymphoma returned after such treatment.

This is the second Phase III study in which Gazyva has shown superior progression free survival compared to Rituxan. In December, BioSpace reported how a combination treatment of Gazyva plus the chemotherapy drug, chlorambucil, significantly increased progression free survival rates in patients with previously untreated chronic lymphocytic leukemia. In touting the superior data from that trial, Stephanie Huang, senior manager of corporate relations at Genentech, told BioSpace that “Gazyva gives people with CLL an important initial treatment option, given for a set six-month period in combination with chemotherapy.”

In addition to the blood cancer and indolent non-Hodgkin’s lymphoma, Genentech is also running a trial testing Gazyva’s for treatment of first-line diffuse large B-cell lymphoma.


Source: BioSpace

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