SOUTH SAN FRANCISCO, CA, USA I February 3, 2015 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase III GADOLIN study, which evaluated treatment options for people with indolent non-Hodgkin’s lymphoma (iNHL) who are refractory to Rituxan® (rituximab) treatment. At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint early. The study showed that people lived significantly longer without disease worsening or death (progression-free survival; PFS) when treated with Gazyva (obinutuzumab) plus bendamustine followed by Gazyva alone, compared to bendamustine alone. The study was stopped prior to its protocol-specified final analysis due to the high level of benefit seen in the Gazyva arm compared to the bendamustine arm. There were no unexpected adverse events with Gazyva.
“GADOLIN is the first of our pivotal Phase III studies of Gazyva to be completed in the non-Hodgkin’s lymphoma setting, building on the positive results we have seen in chronic lymphocytic leukemia,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are delighted that this study could be evaluated early due to the strength of its data, which we believe supports Gazyva’s potential in combination with bendamustine for people whose Rituxan-based therapy failed to adequately control their disease.”
Data from this pivotal study will be submitted for presentation at an upcoming medical meeting and to the U.S. Food and Drug Administration, European Medicines Agency and other health authorities around the world for approval consideration.
About the GADOLIN Study
GADOLIN (NCT01059630; GA04753g) is a Phase III open-label, multicenter, randomized two-arm study evaluating Gazyva plus bendamustine followed by Gazyva alone for up to two years compared to bendamustine alone in 413 patients with indolent non-Hodgkin’s lymphoma whose disease progressed during or following Rituxan-based therapy. The primary endpoint of the study is PFS, with secondary endpoints including response rate (RR), best response and overall survival (OS).
About Non-Hodgkin’s Lymphoma
There are two main types of lymphoma: Hodgkin’s lymphoma and non-Hodgkin’s lymphoma (NHL). NHL has two subsets, aggressive and indolent (slow-growing).
NHL represents approximately 85 percent of all lymphomas diagnosed. According to the American Cancer Society, it is expected that nearly 72,000 people will be diagnosed with NHL in the United States in 2015, and nearly 20,000 will die from the disease.
Most cases of NHL start in B-lymphocytes, cells that are part of the body’s immune system and help to defend the body against infections. B-cell lymphoma develops when these cells become cancerous and begin to multiply and collect in the lymph nodes or lymphatic tissues such as the spleen.
About Gazyva
Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on B-cells. It attacks targeted cells both directly and together with the body’s immune system. Gazyva is thought to have an increased ability to induce direct cell death and induces greater activity in how it recruits the body’s immune system to attack B-cells (antibody dependent cellular cytotoxicity; ADCC) when compared to Rituxan. 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 Idec.
Gazyva continues to be investigated in a large clinical program, which includes the head-to-head Phase III GOYA study comparing Gazyva plus chemotherapy to Rituxan plus chemotherapy in newly diagnosed (first-line) diffuse large B-cell lymphoma (DLBCL; an aggressive form of NHL) and the head-to-head Phase III GALLIUM study comparing Gazyva plus chemotherapy to Rituxan plus chemotherapy in previously untreated (first-line) indolent non-Hodgkin’s lymphoma. Additional combination studies are planned or underway across a range of blood cancers.
Gazyva Indication
Gazyva 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.
About Genentech In Hematology
For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. Genentech’s pipeline of potential hematology medicines includes an antibody-drug conjugate (anti-CD79b; polatuzumab vedotin), a small molecule antagonist of MDM2 (RG7388) and in collaboration with AbbVie, a small molecule BCL-2 inhibitor (GDC-0199/ABT-199; venetoclax). Genentech’s dedication to developing novel molecules in hematology expands beyond oncology, with the development of the investigational hemophilia A treatment ACE910.
About Genentech
Founded more than 35 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
SOURCE: Genentech
Post Views: 28
SOUTH SAN FRANCISCO, CA, USA I February 3, 2015 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase III GADOLIN study, which evaluated treatment options for people with indolent non-Hodgkin’s lymphoma (iNHL) who are refractory to Rituxan® (rituximab) treatment. At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint early. The study showed that people lived significantly longer without disease worsening or death (progression-free survival; PFS) when treated with Gazyva (obinutuzumab) plus bendamustine followed by Gazyva alone, compared to bendamustine alone. The study was stopped prior to its protocol-specified final analysis due to the high level of benefit seen in the Gazyva arm compared to the bendamustine arm. There were no unexpected adverse events with Gazyva.
“GADOLIN is the first of our pivotal Phase III studies of Gazyva to be completed in the non-Hodgkin’s lymphoma setting, building on the positive results we have seen in chronic lymphocytic leukemia,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are delighted that this study could be evaluated early due to the strength of its data, which we believe supports Gazyva’s potential in combination with bendamustine for people whose Rituxan-based therapy failed to adequately control their disease.”
Data from this pivotal study will be submitted for presentation at an upcoming medical meeting and to the U.S. Food and Drug Administration, European Medicines Agency and other health authorities around the world for approval consideration.
About the GADOLIN Study
GADOLIN (NCT01059630; GA04753g) is a Phase III open-label, multicenter, randomized two-arm study evaluating Gazyva plus bendamustine followed by Gazyva alone for up to two years compared to bendamustine alone in 413 patients with indolent non-Hodgkin’s lymphoma whose disease progressed during or following Rituxan-based therapy. The primary endpoint of the study is PFS, with secondary endpoints including response rate (RR), best response and overall survival (OS).
About Non-Hodgkin’s Lymphoma
There are two main types of lymphoma: Hodgkin’s lymphoma and non-Hodgkin’s lymphoma (NHL). NHL has two subsets, aggressive and indolent (slow-growing).
NHL represents approximately 85 percent of all lymphomas diagnosed. According to the American Cancer Society, it is expected that nearly 72,000 people will be diagnosed with NHL in the United States in 2015, and nearly 20,000 will die from the disease.
Most cases of NHL start in B-lymphocytes, cells that are part of the body’s immune system and help to defend the body against infections. B-cell lymphoma develops when these cells become cancerous and begin to multiply and collect in the lymph nodes or lymphatic tissues such as the spleen.
About Gazyva
Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on B-cells. It attacks targeted cells both directly and together with the body’s immune system. Gazyva is thought to have an increased ability to induce direct cell death and induces greater activity in how it recruits the body’s immune system to attack B-cells (antibody dependent cellular cytotoxicity; ADCC) when compared to Rituxan. 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 Idec.
Gazyva continues to be investigated in a large clinical program, which includes the head-to-head Phase III GOYA study comparing Gazyva plus chemotherapy to Rituxan plus chemotherapy in newly diagnosed (first-line) diffuse large B-cell lymphoma (DLBCL; an aggressive form of NHL) and the head-to-head Phase III GALLIUM study comparing Gazyva plus chemotherapy to Rituxan plus chemotherapy in previously untreated (first-line) indolent non-Hodgkin’s lymphoma. Additional combination studies are planned or underway across a range of blood cancers.
Gazyva Indication
Gazyva 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.
About Genentech In Hematology
For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. Genentech’s pipeline of potential hematology medicines includes an antibody-drug conjugate (anti-CD79b; polatuzumab vedotin), a small molecule antagonist of MDM2 (RG7388) and in collaboration with AbbVie, a small molecule BCL-2 inhibitor (GDC-0199/ABT-199; venetoclax). Genentech’s dedication to developing novel molecules in hematology expands beyond oncology, with the development of the investigational hemophilia A treatment ACE910.
About Genentech
Founded more than 35 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
SOURCE: Genentech
Post Views: 28
