Obinutuzumab (Gazyva) at ASCO

Encouraging results with Gazyva.

Cancer survivors are living longer than ever before, and these leaps and bounds are in part a due to new medicines. Today in Chicago, at a scientific conference called ASCO -- the annual meeting of the American Society of Clinical Oncology -- cancer experts are confronting key challenges in oncology.

They are also feeling genuine optimism, and at times, excitement. Late-breaking data show that Gazyva, a new anti-cancer medicine, is helping a special group of folks who are battling a kind of blood cancer known as non-Hodgkin lymphoma, or NHL.

About Non-Hodgkin's Lymphoma

There are two main types of lymphoma: Hodgkin’s lymphoma and NHL. Approximately 85 percent of all lymphomas diagnosed are NHL. 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.

About the Study

Good options already exist for people battling different types of blood cancers. However, as survivors know, sometimes it is not just a matter of winning a single battle.

Many people are familiar with rituximab (Rituxan), and the gains in survival associated with the use of such monoclonal antibodies -- large proteins bio-engineered to target and destroy cancer cells in conjunction with chemotherapy more efficiently than chemotherapy alone.

The study presented at ASCO used a novel monoclonal antibody called obinutuzumab that has been approved by the FDA under the trade name Gazyva since 2013 for the treatment of chronic lymphocytic leukemia in combination with chlorambucil chemotherapy in treatment-naive patients.

“We developed Gazyva to improve upon current medicines and were pleased to see how it provided a benefit for people who stopped responding to standards of care,” says Nancy Valente, M.D., Vice President, Global Hematology Development Genentech.

The study, called the GADOLIN study, demonstrates the potential of Gazyva in this setting.

Dr. Valente notes that the plan is to apply for approval of Gazyva in NHL based on these data and that they are looking forward to seeing the results from two other large studies that are comparing Gazyva head-to-head to one of their more established medicines.


Participants in this study were men and women with cancer -- 413 of them. They all had slow-growing or indolent NHL that had progressed despite treatment. Specifically, their cancers were refractory to rituximab-based therapy -- that is, rituximab or rituximab plus chemotherapy -- which means their disease had progressed during or within six months of that treatment.


Study participants with previously treated slow-growing NHL were placed into 2 different groups, for additional treatment:

  • Gazyva plus bendamustine, followed by Gazyva alone
  • Bendamustine chemotherapy alone


  • Gazyva-based treatment reduced the risk of disease worsening or death by 45 percent compared to chemotherapy alone.
  • The study was stopped early due to the high level of benefit seen in the Gazyva group compared to the bendamustine group – that is, it would not have been ethical to keep the bendamustine group blinded as to the results in the Gazyva group.
  • There were no unexpected safety signals identified with Gazyva.

What this Means

A person with indolent NHL often goes through rounds of relapse and remission, and options may be limited if rituximab-based treatment stops working. So, a new combination that seems to work quite well in refractory patients is good news.

"Most people with indolent NHL relapse repeatedly, and treatment options become more limited and responses to therapy tend to be less durable each time the disease returns. I’m encouraged by the GADOLIN data because obinutuzumab and bendamustine is a novel combination that appears to be highly effective,” says Laurie Sehn, M.D., Medical Oncologist at the BC Cancer Agency and Clinical Associate Professor at the University of British Columbia.

About Gazyva

In the present lymphoma study, Gazyva extended the time people with refractory indolent NHL lived without their disease worsening. Genentech and Roche, the biotechnology companies developing this medicine, will submit data from this study to regulatory authorities in the United States, Europe and around the world for approval consideration.

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.


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.

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