Patients with follicular lymphoma may soon have a new treatment option, as Genentech recently demonstrated that Gazyva (obinutuzumab) improved survival times without disease progression compared to standard treatment with Rituxan (rituximab).
Data from the Phase 3 GALLIUM clinical trial (NCT01332968), which compared the drugs in previously untreated follicular lymphoma patients, were presented at the 58th American Society of Hematology Annual Meeting (ASH 2016).
Trial results were selected by the meeting organization committee to be presented at the Plenary Scientific Session as one of six most important presentations.
Gazyva is an antibody that targets a protein known as CD20 on B-cells, and so has the same mechanism of action as Rituxan. The trial randomized patients to receive either Gazyva or Rituxan in combination with chemotherapy, followed by up to two years of treatment with either Gazyva or Rituxan alone.
Already, in a planned interim analysis in May 2016, an independent data monitoring committee determined that the study had met its primary goal — improving progression-free survival — ahead of schedule. Findings showed a 34 percent lower risk of progression or death in patients treated with Gazyva and chemotherapy, compared to those receiving Rituxan and chemotherapy.
Gazyva also increased the time to next treatment and the number of patients without evidence of minimal residual disease, meaning they lacked any traces of cancer in the blood and bone marrow. Median progression-free survival had not been reached at the time of analysis.
“Follicular lymphoma, the most common slow-growing form of non-Hodgkin’s lymphoma, is an incurable blood cancer characterized by cycles of remission and disease progression, and becomes harder to treat with every relapse,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a press release.
“This study of Gazyva-based treatment is the first and only Phase III trial to date to show superior progression-free survival compared to Rituxan-based treatment, the current standard of care, in previously untreated follicular lymphoma.”
The most common side effects reported during the trial were low blood cell counts, fever, infusion-related reactions, and infections, and no new types of adverse events were observed.
Gazyva has been explored in previous Phase 3 trials in patients with chronic lymphocytic leukemia (NCT01010061, NCT01998880, NCT02053610 ) and in patients with indolent non-Hodgkin’s lymphoma (NCT01059630) who did not respond to Rituxan.
The trial data will now support Genentech in its applications for regulatory approval of the drug with health authorities around the world.