Roche's blood cancer drug Gazyva trials show no significant improvements over older drug
18 Jul 2016
Swiss drugmaker Roche said trials showed its new blood cancer drug Gazyva had failed to deliver significant improvements over an older medicine in people with an aggressive type of blood cancer, which comes as a setback to its fight against competition from biosimilars.
Gazyva failed to cut the risk of disease worsening or death for people with previously untreated diffuse large B-cell lymphoma, over current drug Rituxan in a phase III GOYA study, Roche said today.
Diffuse large B-cell lymphoma, (DLBCL) the most common form on non-Hodgkin's lymphoma, accounts an estimated 25,000 new US cases of the cancer with 10,000 deaths from it, each year.
"Two previous studies showed Gazyva/Gazyvaro helped people with previously untreated follicular lymphoma or chronic lymphocytic leukemia live longer without their disease worsening compared to MabThera/Rituxan, when each was combined with chemotherapy," Roche's chief medical officer Sandra Horning said.
"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."
The study included 1,418 who had not been previously treated.
According to commentators, clinical trials with the new drug were important in deciding how well the Swiss company was placed to fend off cheaper competition from so-called biosimilar copies of Rituxan, which would be in the market in the next couple of years.
The company said a breakdown of the figures for the trial would posted at an ''upcoming medical meeting'' in the near future. Secondary endpoints included overall survival and response rates but these were also not available.
Most people with early-stage DLBCL undergo a short course of immunochemotherapy known as R-CHOP, which is: Rituxan combined with three chemotherapy drugs: cyclophosphamide, hydroxydaunorubicin and vincristine, as also the the steroid prednisolone.
A number of pharmas and biotechs were now trying a new method in this type of blood cancer as also others known as CAR-T--which in some recent trials had delivered impressive results, although it had also come with some questions over safety in recent months.
