Healthcare Industry News: liver failure
News Release - July 18, 2016
Genentech Provides Update on Phase III Study of Gazyva(R) in People With Previously Untreated Diffuse Large B-Cell LymphomaSOUTH SAN FRANCISCO, Calif.--(Healthcare Sales & Marketing Network)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III GOYA study evaluating Gazyva® (obinutuzumab) plus CHOP chemotherapy (G-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL) did not meet its primary endpoint of significantly reducing the risk of disease worsening or death (progression-free survival; PFS) compared to Rituxan® (rituximab) plus CHOP chemotherapy (R-CHOP). Adverse events with Gazyva and Rituxan were consistent with those seen in previous clinical trials when each was combined with various chemotherapies. Data from the GOYA study will be presented at an upcoming medical meeting.
“Two previous studies showed Gazyva helped people with previously untreated follicular lymphoma or chronic lymphocytic leukemia live longer without their disease worsening compared to Rituxan, when each was combined with chemotherapy. We were hopeful we could show a similar result for people with diffuse large B-cell lymphoma and once again improve on the standard of care,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We will continue to analyze the GOYA data to better understand the results, and to study other investigational treatments in this disease with the goal of further helping these patients.”
About the GOYA study
GOYA (NCT01287741) is a global Phase III open-label, multicenter, randomized two-arm study examining the efficacy and safety of the combination of Gazyva plus CHOP chemotherapy (G-CHOP) compared to Rituxan plus CHOP chemotherapy (R-CHOP). GOYA included 1,418 previously untreated patients with CD20-positive DLBCL. The primary endpoint of the study is investigator-assessed PFS, with secondary endpoints including PFS assessed by independent review committee (IRC), response rate (overall response, ORR; and complete response, CR), overall survival (OS), disease free survival (DFS) and safety profile. The GOYA study is being conducted in cooperation with the Fondazione Italiana Linfomi (FIL, Italy).
Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin’s lymphoma (NHL), accounting for about one in three cases of NHL. DLBCL is an aggressive (fast-growing) type of NHL. As many as 40 percent of patients will relapse, at which point their prognosis is poor. In the United States, it is estimated that more than 24,000 new cases of DLBCL will be diagnosed in 2016.
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. Gazyva was discovered by Roche Glycart AG, a wholly owned, independent research unit of Roche. In the United States, Gazyva is part of a collaboration between Genentech and Biogen.
Combination studies investigating Gazyva with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are planned or underway across a range of blood cancers.
Gazyva U.S. Indications
Gazyva® (obinutuzumab) is a prescription medicine used:
With the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.
With the chemotherapy drug, bendamustine, followed by Gazyva alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment.
Important Safety Information
Patients must tell their doctor right away about any side effects they experience. Gazyva can cause side effects that can become serious or life threatening, including:
Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If a patient has had history of hepatitis B infection, Gazyva could cause it to return. Patients should not receive Gazyva if they have active hepatitis B liver disease. The patient’s doctor or healthcare team will need to screen for hepatitis B before, and monitor the patient for hepatitis during and after, treatment with Gazyva. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes.
Progressive Multifocal Leukoencephalopathy (PML)
PML is a rare and serious brain infection caused by a virus. PML can be fatal. A patient’s weakened immune system could put the patient at risk. The patient’s doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.