Genentech at ASH

News from Genentech at ASH.

About Genentech

Genentech is a company that enjoys a semi-legendary status for those who have studied medicine or biotechnology -- as well as countless others. Students of molecular biology today learn that Genentech was first to clone human insulin in 1978, essentially opening the door to pharmaceutical manufacturing of human insulin, which became widely available for diabetics by the mid-1980s.

Genentech went on to develop many therapies, including human growth hormone, clotting factors for people with bleeding disorders, and a therapy that is well-known to oncologists and rheumatologists: rituximab, a monoclonal antibody.

Rituximab in History

For more than 30 years, Genentech has been keeping up with the science, as well as generating new science of its own. In 1997, Genentech and partner IDEC Pharmaceuticals -- now Biogen Idec Inc. -- received FDA approval to market Rituxan (rituximab) for the treatment of patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin lymphoma.

Today, rituximab, in combination with fludarabine and cyclophosphamide, is also indicated for the treatment of patients with CD20-positive chronic lymphocytic leukemia, or CLL. Rituximab is also used for moderately- to severely-active rheumatoid arthritis in people who have had an inadequate response to one or more of the so-called TNF antagonist therapies.

Genentech Today

A member of the Roche Group, Genentech is seeking solutions to unmet medical needs, focusing on medicines to treat patients with serious medical conditions.

They have over 13,000 employees working to solve unmet medical needs; 785,000 square feet devoted to research; and 35 medicines on the market. Headquartered in South San Francisco, California, Genentech has developed several cancer therapies considered breakthroughs -- that have changed the standard of care and help patients with cancer live longer lives.

On the horizon this year will be new information about Gazyva (obinutuzumab) and venetoclax, the company’s BCL-2 inhibitor being developed in collaboration with AbbVie. Genentech recently announced that the FDA has granted priority review to its supplemental Biologics License Application (sBLA) for Gazyva, based on data from a study called GADOLIN. This is the first application for Gazyva in non-Hodgkin's lymphoma.

At the 57th American Society of Hematology (ASH) annual meeting

Genentech will present more than 45 abstracts highlight studies for eight medicines across various blood diseases. Abstracts will feature eight of its approved or investigational medicines in the Annual Meeting from December 5-8 in Orlando.

Data for Gazyva include results from combination studies such as the Phase IIIb GREEN study and the pivotal CLL11 and GADOLIN studies. GREEN results will include data for Gazyva in combination with bendamustine in previously untreated chronic lymphocytic leukemia (CLL).

Genentech will also share updated results from the Phase III CLL11 study, which formed the basis of the Gazyva approval in previously untreated CLL in combination with chlorambucil, and further data from the pivotal Phase III GADOLIN study for the investigational use of Gazyva in patients with indolent non-Hodgkin’s lymphoma (NHL) that is refractory to rituximab-based treatment, that add to the positive results presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June this year.

Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on B-cells, the same protein that is also targeted by rituximab. Gazyva destroys the CD20 bearing 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, or ADCC -- when compared to rituximab. 

Side Effects and Adverse Events

When used alone, the side effects of Gazyva are, in general, less pronounced than the side effects of chemotherapy agents.

The most common side effects with Gazyva are infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhea.

Gazyva can cause serious or life-threatening adverse events: Hepatitis B reactivation, progressive multifocal leukoencephalopathy, or PML, infusion reactions, tumor lysis syndrome and infections. Also, Gazyva can cause infusion reactions, a decrease in the white blood cell counts and a decrease in the platelet counts that can be serious or life-threatening.


First Successful Laboratory Production of Human Insulin Announced. Accessed November 2015.

Company Information. Accessed November 2015.

GADOLIN: Primary results from a phase III study of obinutuzumab plus bendamustine compared with bendamustine alone in patients with rituximab-refractory indolent non-Hodgkin lymphoma. J Clin Oncol 33, 2015 (suppl; abstr LBA8502).

Targeted treatment for chronic lymphocytic leukemia: clinical potential of obinutuzumab. Pharmacogenomics and Personalized Medicine. 2014; Dec 22;8:1-7.

Continue Reading