Trial Results Show Significant Results Thereby Obtaining FDA Approval
Genentech announced the FDA approval for their anti-CD20 agent drug, Gazyva (obinutuzumab), for follicular lymphoma patients who relapsed after, or are refractory to, a rituximab-containing regimen. This FDA approval was given after significant results were shown during the phase III clinical research trial for their Gazyva drug.
Sandra Horning, MD, Genentech’s CMO and head of Global Product Development stated, “people with follicular lymphoma whose disease returns or worsens despite treatment with a Rituxan-containing regimen need more options because the disease becomes more difficult to treat each time it comes back.”
The FDA also approved of obinutuzumab for use in combination with chlorambucil as a first-line primary treatment for chronic lymphocytic leukemia patients.
The Phase III GADOLIN Clinical Research Trial
It was due to GADOLIN’s study results which allowed for the FDA approval. Obinutuzumab and bendamustine followed by obinutuzumab monotherapy showed to reduce the disease progression by 52% when compared to follicular lymphoma patients who received bendamustine treatment alone.
413 patients with rituximab-refractor indolent non-Hodgkin lymphoma (of which the most common being follicular lymphoma, 321 patients) were studied in the multicenter, open-label GADOLIN trial. Rituximab-refractory classified patients meant that they did not show progression from rituximab monotherapy or rituximab + chemotherapy, or had shown a relapse within 6 months of the last rituximab-based (monotherapy or the combo chemotherapy) dose.
“Gazyva plus bendamustine provides a new treatment option that can be used after relapse to significantly reduce the risk of progression or death,” said Horning.
Details of the GADOLIN Clinical Research Trial
During the clinical research trial, the median patient age was 63 years, about 4 months had passed since their last therapy, and more than 90% of the patients were refractory, had no response, to their last treatment.
Group 1 (experimental arm) received bendamustine and obinutuzumab treatments every 2 months for 2 years. Group 2 (comparator group) received bendamustine monotherapy treatments.
Group 1’s progression-free survival (PFS), the primary endpoint measure, had a median of 29.2 months compared to Group 2’s 13.7 months. At 24.1 months, death risk had reduced by 38% through Group 1’s obinutuzumab regimen compared to Group 2’s monotherapy.
Enroll As a Patient for Future Clinical Trials
Genentech proudly shared their new FDA approval status for follicular lymphoma late February, following their GADOLIN clinical research trial. Such advancements in clinical research are only made possible by the combination of both researchers’ and patients’ efforts. Without the volunteers from the non-Hodgekin lymphoma’s patient population, these critical results would not have been as impactful. Therefore, if you would like to help make a difference in research trials just like this, sign up and enroll as a patient. Let’s fight the good fight together.