- New results from the Phase III GALLIUM study which compared Gazyva® (obinutuzumab) plus chemotherapy to Rituxan® (rituximab) plus chemotherapy in previously untreated follicular lymphoma will be presented in the Plenary Scientific Session
- New results for Venclexta™ (venetoclax) and investigational medicine emicizumab will also be presented at the meeting
- FDA has accepted the Biologics License Application for a subcutaneous formulation of Rituxan® (rituximab/hyaluronidase)
SOUTH SAN FRANCISCO, CA, USA I November 3, 2016 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that more than 60 abstracts featuring nine of its approved or investigational medicines will be presented during the 58th American Society of Hematology (ASH) Annual Meeting from December 3-6 in San Diego. The abstracts include more than 20 oral presentations across a broad range of medicines and combinations.
“The breadth of data we are presenting at ASH this year reflects our deep commitment to people with blood diseases,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are excited to share the results of the pivotal GALLIUM study in previously untreated follicular lymphoma, which showed that people treated with Gazyva plus chemotherapy lived significantly longer without their disease worsening than those treated with Rituxan plus chemotherapy.”
The results from the Phase III GALLIUM study have been selected for presentation during the Plenary Scientific Session, which honors the top six abstracts submitted to the meeting, as determined by the ASH Program Committee. Results from other studies of Gazyva will also be presented at the meeting, including an overall survival update from the Phase III GADOLIN study in Rituxan-refractory indolent (slow-growing) non-Hodgkin’s lymphoma (NHL) and the first results from the Phase III GOYA study in previously untreated diffuse large B-cell lymphoma (DLBCL).
Updated results from the Phase III SABRINA study comparing subcutaneous and intravenous Rituxan in previously untreated follicular lymphoma will be presented. The U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the subcutaneous formulation of Rituxan, with an action date of June 26, 2017. Genentech and Biogen collaborate on Rituxan and Gazyva in the United States.
Early results will be shared for combinations of Venclexta with either Gazyva or Rituxan in chronic lymphocytic leukemia (CLL) and certain types of NHL. Further follow-up from early studies in multiple myeloma (MM) and acute myeloid leukemia (AML) that support further investigation of Venclexta in these diseases will also be presented. Venclexta is being developed by AbbVie and Genentech.
The first cohort from a non-interventional study of people with hemophilia will be presented, including real world safety and efficacy data from patients with inhibitors to factor VIII replacement therapy treated with current standard of care according to routine clinical practice. Separately, there are currently three pivotal studies underway to explore the safety and efficacy of emicizumab in the treatment of hemophilia A: a Phase III study in people 12 years of age or older with hemophilia A with factor VIII inhibitors investigating weekly dosing; a Phase III study in people younger than 12 years of age with factor VIII inhibitors investigating weekly dosing; and a Phase III study in people 12 years of age or older without factor VIII inhibitors investigating weekly and every other week dosing. Emicizumab was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed by Genentech.
Key abstracts featuring Genentech medicines that will be presented at ASH can be found in the table below.
Follow Genentech on Twitter via @Genentech and keep up to date with ASH Annual Meeting news and updates by using the hashtag #ASH16.
Overview of key presentations featuring Genentech medicines at ASH 2016
| Medicine | Abstract title |
Abstract number/ Presentation details |
| Gazyva (investigational use) | Obinutuzumab-Based Induction and Maintenance Prolongs Progression-Free Survival in Patients with Previously Untreated Follicular Lymphoma: Primary Results of the Randomized Phase 3 GALLIUM Study |
#6 (Plenary Scientific Session) Sunday, Dec. 4 2:00–4:00 PM PT |
| Minimal Residual Disease Assessment in Patients with Follicular Lymphoma Treated with Obinutuzumab or Rituximab as First-Line Induction Immunochemotherapy in the Phase III GALLIUM Study |
#613 (Oral presentation) Monday, Dec. 5 7:00 AM PT (7:00–8:30 AM PT) |
|
| Obinutuzumab or Rituximab plus CHOP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma: Final Results from an Open Label, Randomized Phase 3 Study (GOYA) |
#470 (Oral presentation) Sunday, Dec. 4 4:45 PM PT (4:30–6:00 PM PT) |
|
|
Gazyva (approved use, updated study results) |
Obinutuzumab plus Bendamustine Followed by Obinutuzumab Maintenance Prolongs Overall Survival Compared with Bendamustine Alone in Patients with Rituximab-Refractory Indolent Non-Hodgkin Lymphoma: Updated Results of the GADOLIN Study |
#615 (Oral presentation) Monday, Dec. 5 7:30 AM PT (7:00–8:30 AM PT) |
|
Rituxan (subcutaneous formulation) (investigational) |
Longer Term Efficacy and Safety of Subcutaneous Compared with Intravenous Rituximab: Updated Results of the Phase III SABRINA Study |
#1103 (Oral presentation) Monday, Dec. 5 5:30 PM PT (4:30–6:00 PM PT) |
|
Venclexta (investigational use) |
Safety and Efficacy of Venetoclax and Obinutuzumab in Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) and Coexisting Medical Conditions: Final Results of the Run-In Phase of the Randomized CLL14 Trial |
#2054 (Poster) Saturday, Dec. 3 5:30–7:30 PM PT |
| Results of a Phase Ib Study of Venetoclax plus R- or G-CHOP in Patients with B-cell Non-Hodgkin Lymphoma (CAVALLI) |
#3032 (Poster) Sunday, Dec. 4 6:00–8:00 PM PT |
|
| Phase 2 Study of Venetoclax plus Rituximab or Randomized Venetoclax plus Bendamustine+Rituximab (BR) Versus BR in Patients with Relapsed/Refractory Follicular Lymphoma: Interim Data (CONTRALTO) |
#617 (Oral presentation) Monday, Dec. 5 8:00 AM PT (7:00–8:30 AM PT) |
|
| Safety and Efficacy of Venetoclax plus Low-Dose Cytarabine in Treatment-Naive Patients Aged ≥65 Years with Acute Myeloid Leukemia (M14-387) |
#2843 (Oral presentation) Saturday, Dec. 3 10:45 AM PT (9:30–11:30 AM PT) |
|
|
Emicizumab (investigational) |
Bleeding Events and Safety Outcomes in Patients with Hemophilia A with Inhibitors: A Prospective, Multicenter, Non-Interventional Study |
#3800 (Poster) Monday, Dec. 5 6:00–8:00 PM PT |
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. In addition to approved medicines, Genentech’s pipeline of investigational hematology medicines includes an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a small molecule antagonist of MDM2 (idasanutlin/RG7388). Genentech’s dedication to developing novel medicines for blood diseases expands beyond oncology, with the development of the investigational hemophilia A treatment emicizumab (ACE910). For more information visit http://www.gene.com/hematology.
About Genentech
Founded 40 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
