Swiss pharmaceutical company Roche is facing a huge blow to its cancer treatment study as the phase III trial for its blood cancer drug called Gazyva (Obinutuzumab) failed to meet its main endpoint.
On Monday, Roche announced that Gazyva did not deliver significant improvements compared to an older drug among people who were diagnosed with diffuse large B-cell lymphoma — an aggressive form of blood cancer.
More specifically, Gazyva did not reduce the progression, worsening and risk of death for people with this blood cancer over the drug Rituxan in a phase III GOYA study.
Diffuse large B-cell lymphoma is the most recurrent type of non-Hodgkin's lymphoma, with approximately 25,000 new cases and 10,000 deaths from it being recorded in the United States every year.
Sandra Horning, chief medical officer at Roche, says two previous studies showed that Gazyva helped patients with chronic lymphocytic leukemia or untreated follicular lymphoma live longer without their disease deteriorating better than Rituxan, especially when both were individually added to 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," says Horning.
The phase III trial involved 1,418 previously untreated patients with diffuse large B-cell lymphoma. The study's main endpoint was PFS or progression-free survival assessed by investigators, while the secondary endpoint was PFS assessed by an independent review committee (IRC), complete response, response rate, overall survival, disease-free survival and safety profile.
Gazyva is an engineered monoclan antibody designed to attach to a protein expressed on certain B-cells known as CD20. This protein is not expressed on plasma cells or stem cells.
The treatment is supposed to attack and destroy B-cells directly and by working with the immune system of the patient's body.
According to Roche, Gazyva is currently approved in more than 70 countries across the world in combination with the drug Chlorambucil for the treatment of chronic lymphocytic leukemia.
The approval for Chlorambucil-Gazyva was based on the CLL11 study, which showed significant improvements across multiple clinical endpoints.
Additionally, Gazyva was approved in February 2016 by the Food and Drug Administration in combination with the drug Bendamustine followed by Gazyva alone for patients with follicular lymphoma. If these patients did not respond to the Rituxan regiment, they will be given the Bendamustine-Gazyva combination as an alternative.
Clinical trials are essential in deciding how well Roche is poised to fend off competition from "biosimilar copies" of Rituxan, according to Reuters. These copies are expected to hit the market over the next few years.
