A phase 3 study of Gazyva (obinutuzumab) in indolent non-Hodgkin lymphoma (iNHL) has been stopped early after an interim analysis found that the drug improved progression-free survival (PFS), which meant patients lived longer without the disease worsening or progressing. Results are expected to be announced at an upcoming scientific meeting and the company, Genentech, is planning to file the drug for FDA approval in the disease.
The pivotal GADOLIN study (NCT01059630) examined Treanda (bendamustine) compared with Gazyva plus Treanda followed by Gazyva in patients with iNHL that progressed on Rituxan (rituximab). An independent panel determined that the study met its primary endpoint of a significant improvement in PFS for the Gazyva arm. In addition, the trial also looked at survival and the cancer’s overall response to the regimen.
GADOLIN is the first of Gazyva’s pivotal phase 3 studies to be completed in the non-Hodgkin lymphoma setting, building on the positive results seen in chronic lymphocytic leukemia, Sandra Horning, Genentech’s chief medical officer and head of Global Product Development, said in a statement.
“We are delighted that this study could be evaluated early due to the strength of its data, which we believe supports Gazyva’s potential in combination with bendamustine for people whose Rituxan-based therapy failed to adequately control their disease,” she said.
Promising data for Gazyva in relapsed or refractory iNHL from the phase 2 GAUGUIN trial were published in the Journal of Clinical Oncology in 2013. GAUGUIN included 40 patients, 34 of whom had follicular lymphoma. Thirty-eight patients had received Rituxan and 22 were refractory to the drug.
The overall response rate was 55 percent in the higher-dose group group and 17 percent in the lower-dose group. The median PFS was 11.9 months and 6 months, respectively.
When Genentech files for regulatory approval for Gazyva in iNHL, it will be seeking a second indication for the drug. It is currently approved by the FDA for use in combination with chlorambucil as a first-line treatment for patients with chronic lymphocytic leukemia.