Canada’s medical regulatory agency has approved a Gazyva-based combo therapy for follicular lymphoma patients whose disease progressed either while or after they were treated with a Rituxan-based regimen.
The therapy that Health Canada approved is a combination of Gazyva (obinutuzumab) and bendamustine, followed by Gazyva alone. It applies to cases where patients’ disease progressed during or within six months of their being treated with a regimen based on Rituxan (rituximab).
The approval was based on results of the Phase 3 GADOLIN trial (NCT01059630). It revealed that combining Gazyva with bendamustine — available as Bendeka or Treanda — in patients with indolent non-Hodgkin’s lymphoma who were unable to respond to Rituxan doubled the patients’ progression-free survival rate. The combo therapy led to 29.2 months of progression-free survival, versus 13.7 months for bendamustine alone.
The trial included 396 patients. Of these, 194 were treated with the combo regimen, and 202 with bendamustine alone. Twenty-four percent of the patients were Canadians being treated at 10 clinical trial sites across the country. Patients were followed for a median of 20 months.
“While many Canadians live with follicular lymphoma for several years, there are limited options available today that address the needs of patients who do not respond to their prescribed treatment” or whose therapy stops working, Robin Markowitz, CEO of Lymphoma Canada, said in a press release. “It is exciting to see that research is continuing to drive advances in this space, providing patients with more treatment options to help them combat their disease.”
The Lymphoma Research Foundation says follicular lymphoma (FL) is the most common slow-growing, or indolent, form of non-Hodgkin lymphoma (iNHL), accounting for 20 percent to 30 percent of all cases.
Gazyva is a monoclonal antibody engineered to attach to the CD20 protein found in certain B-cells. It is believed to attack folliculur lymphoma cells directly and in conjunction with the body’s immune system.
Chemotherapy and targeted treatments such as Rituxan – the current standard of care – have improved patients’ survival rates. However, follicular lymphoma often recurs.
“Despite significant improvements in the treatment of follicular lymphoma, including the addition of rituximab to primary chemotherapy and the use of rituximab maintenance, follicular lymphoma remains an incurable disease,” said John Kuruvilla, a hematologist or blood specialist at Princess Margaret Hospital and an associate professor at the University of Toronto. “New treatment options are needed for Canadians dealing with relapsed or refractory follicular lymphomas. GAZYVA in combination with bendamustine represents an important new advance for patients who have follicular lymphoma that has relapsed after, or was refractory to, a rituximab-based treatment regimen.”