Genentech Receives a Blow After Lymphoma Drug Flunks Phase III Test
July 18, 2016
By Alex Keown, BioSpace.com Breaking News Staff
SOUTH SAN FRANCISCO, Calif. — Despite showing promise in treating a number of cancers, Genentech ’s Gazyva combined with chemotherapy failed to meet its primary endpoints in a Phase III trial for patients with previously untreated diffuse large B-cell lymphoma, the company announced this morning.
Genentech said Gazyva did not show significant reduction of disease worsening or death when compared to Rituxan and chemotherapy. Gazyva had shown promising results in earlier trials as a treatment option for patients with previously untreated follicular lymphoma or chronic lymphocytic leukemia. In May, the company announced interim data from a late stage trial in which Genentech’s Gazyva for the treatment of untreated follicular lymphoma showed a significant difference in the staving off death or reducing the risk of disease progression when compared to Rituxan. Earlier, in December, BioSpace reported how a combination treatment of Gazyva plus the chemotherapy drug, chlorambucil, significantly increased progression free survival rates in patients with previously untreated chronic lymphocytic leukemia. In touting the superior data from that trial, Stephanie Huang, senior manager of corporate relations at Genentech, told BioSpace that “Gazyva gives people with CLL an important initial treatment option, given for a set six-month period in combination with chemotherapy.”
“We were hopeful we could show a similar result for people with diffuse large B-cell lymphoma and once again improve on the standard of care,” Sandra Horning, Genentech’s chief medical officer and head of global product development, said in a statement.
Horning said the company intends to continue evaluating the data from the Goya trial to “better understand the results, and to study other investigational treatments in this disease with the goal of further helping these patients.”
Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body's immune system.
Genentech’s Goya trial was a Phase III study examining the efficacy and safety of the combination of Gazyva plus CHOP chemotherapy compared to Rituxan plus CHOP chemotherapy. The study included 1,418 previously untreated patients with CD20-positive DLBCL, Genentech said. The primary endpoint of the study is investigator-assessed progression-free survival (PFS), with secondary endpoints including PFS assessed by independent review committee, response rate (overall response, ORR; and complete response, overall survival, disease free survival and safety profile. The California-based company said it planned to examine the data and release full details of the study at a coming conference. The study was conducted in cooperation with Italy’s Fondazione Italiana Linfomi, Genentech said.
Shares of Roche , Genentech’s parent company, were down in trading following the release of the news this morning. Roche is currently trading at $252.50 per share.