Roche’s hopes of extending the use of its Gazyvaro into the most common form of non-Hodgkin’s lymphoma have been dashed after it failed a late-stage trial.
Gazyvaro (obinutuzumab) – sold as Gazyva in the US – was unable to improve progression-free survival (PFS) in patients with previously untreated diffuse large B-cell lymphoma (DLBCL) when compared to Roche’s MabThera/Rituxan (rituximab).
Both antibodies given were given alongside standard chemotherapy in the GOYA trial, which enrolled more than 1,400 patients.
Like MabThera, Gazyvaro targets the CD20 receptor but has been designed with sugar molecule side chains that improve its therapeutic and safety profile. It has been billed as a follow-up to Roche’s $7bn-a-year blockbuster – which has been on the market since 1998 – but growth to date has been sluggish.
The drug is already approved to treat chronic lymphocytic leukaemia (CLL) and follicular lymphoma (FL), bringing in around $130m last year, with signs that sales started to accelerate in the first quarter of 2016.
These are much smaller patient populations than DLCBL – which accounts for about a third of call cases of NHL – so the failure of the GOYA trial is a major setback to Roche’s aspirations for Gazyvaro, which is also being positioned as the cornerstone of a number of combination therapies for haematological cancers.
The company has previously suggested it has high expectations for the combination of Gazyvaro with AbbVie-partnered BCL-2 inhibitor venetoclax in CLL and NHL.
“Two previous studies showed Gazyva/Gazyvaro helped people with previously untreated FL or CLL live longer without their disease worsening compared to MabThera/Rituxan, when each was combined with chemotherapy,” said Roche’s chief medical officer Sandra Horning.
“We were hopeful we could show a similar result for people with DLBCL and once again improve on the standard of care,” she added.
MabThera has already started to lose patent protection in some markets – including the EU – and rivals are queuing up to develop biosimilar versions of the blockbuster, including Novartis’ Sandoz unit, Amgen and Mylan, amongst others.
Roche has sought to defend the franchise by developing a subcutaneous formulation of the antibody that reduces the treatment time dramatically and is more patient-friendly than the original intravenous infusion. The new format started rolling out in 2014.