Gazyva® Improves Outcomes Compared to Rituxan® in Untreated Follicular Lymphoma

Treatment including the targeted agent Gazyva (obinutuzumab) delays cancer progression for a longer period of time than treatment with Rituxan (rituximab) among patients with follicular lymphoma who have not received prior therapy. These results were recently presented at a plenary session of the 2016 annual meeting of the American Society of Hematology (ASH).

Follicular lymphoma (FL) is a type of lymphoma, or cancer that starts in immune cells called B-cells. FL is often considered a slow-growing type of cancer, but in its advanced stages, can become more aggressive.

B-cells have molecules on their surface called CD-20 antigens. Since B-cells turn cancerous in FL, agents targeted against the CD-20 antigens promote the immune system to specifically kill the cancer cells, without harming healthy cells in the body.

Standard treatment for FL often includes rituximab, an agent targeted against the CD20 antigen, plus chemotherapy. Obinutuzumab is also an agent targeted against the CD20 antigen; however, it has been engineered in the laboratory to enhance the anti-cancer effects by the immune system. Obinutuzumab is already approved for the treatment of some patients with chronic lymphocytic leukemia, and the treatment of FL that has stopped responding to rituximab.

Researchers recently conducted a large clinical trial to directly compare treatment including obinutuzumab plus chemotherapy, to treatment including rituximab plus chemotherapy in patients with FL. This trial, referred to as the GALLIUM trial included over 1,200 patients who had not received any prior therapy for their FL. One group was treated with rituximab/chemotherapy and the other group was treated with obinutuzumab/chemotherapy. Patients who had anti-cancer responses to their initial therapeutic regimen remained on their treatment with either obinutuzumab or rituximab, without chemotherapy (maintenance therapy).

  • At a median follow-up time of 34.5 months, patients treated with obinutuzumab/chemotherapy had a 34% reduced risk of cancer progression or death compared to those treated with rituximab/chemotherapy.
  • At approximately 3 years, survival without progression of cancer was achieved in 80% of patients treated with obinutuzumab/chemotherapy, compared with 73.3% among patients treated with rituximab/chemotherapy.
  • Severe side effects were more common among patients treated with obinutuzumab/chemotherapy, compared to those treated with rituximab/chemotherapy; however, mortality rates caused by side effects were not different between the two treatment groups.

The researchers concluded that “these data support [obinutuzumab/chemotherapy] becoming a new SoC (standard of care) in previously untreated patients with FL.”

Obinutuzumab is already approved for the treatment of some patients with chronic lymphocytic leukemia, and the treatment of FL that has stopped responding to rituximab.

Reference: Marcus R, Davies A, Ando K, et al. Obinutuzumab-based induction and maintenance prolongs progression-free survival (PFS) in patients with previously untreated follicular lymphoma: primary results of the randomized phase 3 GALLIUM Study. Proceedings from the 2016 annual ASH meeting. Plenary session; Abstract #6. Available at: https://ash.confex.com/ash/2016/webprogram/Paper94744.html. Accessed December 6, 2016.

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