Roche Fails Phase 3 Trial in Non-Hodgkin’s Lymphoma

Swiss drugmaker Roche’s blood cancer drug Gazyva (obinutuzumab) failed to show significant improvements against its older, best-seller MabThera/Rituxan (rituximab) in a late-stage study, the company announced Monday.

Gazyva’s trial missed its primary endpoint in improving progression-free survival in patients with previously untreated diffuse large B-cell lymphoma. The trial, called GOYA, involved nearly 1,500 patients.

Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma (NHL), accounting for up to 30 percent of newly diagnosed cases in the U.S. DLBCL is an aggressive lymphoma, which can arise in lymph nodes or outside the lymphatic system, in the gastrointestinal tract, testes, thyroid, skin, breast, bone, or brain.

The failed trial is considered a setback for Roche, who is counting on new cancer treatments to help offset competition from biosimilars. Interestingly, two previous studies showed that Gazyva performed better than MabThera/Rituxan, when combined with chemotherapy, in patients with previously untreated follicular lymphoma or chronic lymphocytic leukemia. “We were hopeful we could show a similar result for people with DLBCL and once again improve on the standard of care,” said Roche’s chief medical officer Sandra Horning.

Similar to MabThera/Rituxan, Gazyva, a monoclonal antibody, targets CD20, a protein expressed on certain B cells, in treating blood cancers.

Another approach to immunotherapy in treating blood cancers is CAR-T therapy: These therapies involve extracting a patient’s T cells, genetically modifying the T cells to express CARs that target the antigen CD19 — a protein expressed on the cell surface of B-cell lymphomas and leukemias — and then reinfusing the engineered cells into the patient. CAR-T therapy has shown successful results in treating leukemia and lymphoma, yet the experimental treatment’s side effects are being considered.

Data from Gazyva’a trial will be presented at an upcoming medical meeting, Roche announced. “We will continue to analyze the GOYA data to better understand the results, and to study other investigational treatments in this disease with the goal of further helping these patients,” said Horning.