Shortening the time needed for an infusion of Gazyva (obinutuzumab) did not affect the safety of Japanese patients with previously untreated CD20-positive B-cell non-Hodgkin’s lymphoma, a new study shows.
“Safety, tolerability and pharmacokinetics of shorter duration of infusion of obinutuzumab in Japanese patients with B-cell non-Hodgkin lymphoma: final results of the phase II GATS study,” was published in the Japanese Journal of Clinical Oncology.
Gazyva is an antibody that helps treat B-cell cancers by targeting the CD20 protein, found on the surface of immune cells, called B-cells. Studies have shown that Gazyva has led to improvement across a range of lymphoma subtypes.
Gazyva can help slow disease progression or death in patients with previously untreated follicular lymphoma, and improved effectiveness in B-cell non-Hodgkin’s lymphoma (NHL) patients who failed to respond to Rituxan (rituximab), another CD20 inhibitor.
Gazyva is administered intravenously over a three- to four-hour period. But the lengthy and frequent infusions can be burdensome and inconvenient for patients, and increase nursing and administrative staff workloads.
While it might seem better to administer the drug in less time, this might come with an increased risk for infusion-related reactions (IRRs). However, studies of Rituxan have shown that reducing infusion times is feasible.
Japanese researchers conducted a Phase 2 study, called GATS (JO29737, JapicCTI-152 848), to investigate whether Gazyva can be given to patients in less time.
Researchers recruited patients with previously untreated CD20-positive B-cell NHL and given 1,000 mg of intravenous Gazyva on Days 1, 8, and 15 of cycle 1, followed by a 90-minute shorter duration of infusion in up to seven subsequent cycles. Standard chemotherapy also was administered in cycles 1-6.
Among the 35 patients who started treatment, 28 completed all eight cycles. Thirty-one patients started the shorter duration of infusion in cycle 2, and two patients started the shorter duration in subsequent cycles.
Researchers focused on the incidence of serious or worse (grade 3 or higher) infusion-related adverse events in patients who started the shorter duration treatment in cycle 2. There were none.
Overall, there were 21 infusion-related reactions that were mild or moderate, which were reported in 17 patients (49%). Most (86%) took place in cycle 1.
Serious or life-threatening events did occur, including a drop in levels of neutrophils — a type of white blood cell important in fighting off infections — in 66% of patients, and reduced white blood cell count in 23% of patients.
The pharmacokinetics — how a drug is absorbed, distributed, metabolized, and eliminated from the body — of Gazyva in cycle 2 were not affected by the shorter infusion period.
There were no reports of elevated cytokines (molecules that regulate immune responses) associated with the shorter infusion period.
The researchers concluded that “regular infusion and shorter duration of infusion of obinutuzumab have comparable tolerability and pharmacokinetics in Japanese patients.”