Roche flops Phase III B-cell lymphoma test in head-to-head study


Swiss cancer major Roche ($RHHBY) has flubbed a late-stage trial pitting one of its newer drugs against an aging stalwart as it failed to help patients with an aggressive form of blood cancer live longer.

Specifically, the Phase III GOYA study of Gazyva (obinutuzumab) used with a cocktail of chemo agents missed its primary endpoint in improving progression-free survival (PFS) in patients with diffuse large B-cell lymphoma (DLBCL) when compared to Roche’s own blockbuster cancer and autoimmune drug Rituxan (rituximab), also with a chemo regimen.

A breakdown of the figures was not immediately available, although these should, according to the company, be posted at an “upcoming medical meeting” in the near future. Secondary endpoints included response rates and overall survival, but data for these were also not available. The study involved nearly 1,500 patients.

DLBCL is an aggressive type of non-Hodgkin’s lymphoma (NHL). Most people with early-stage DLBCL will be treated with a short course of immunochemotherapy known as R-CHOP, which is: Rituxan combined with three chemotherapy drugs: cyclophosphamide, hydroxydaunorubicin and vincristine, as well as the steroid prednisolone.

A number of pharmas and biotechs are now trying a new method in this type of blood cancer as well as others--known as CAR-T--which in some recent trials has produced impressive data, although it has also come with some lingering questions over safety in recent months.

Kite Pharma ($KITE) has in fact already gone to European regulators with data for its candidate KTE-C19, the CAR-T drug that is now being hurried through the EMA for patients with refractory DLBCL.

The FDA has already granted its breakthrough therapy designation to KTE-C19 for patients with DLBCL, as well as in primary mediastinal B-cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL). 

Kite's drug is an investigational immunotherapy, in which a patient's T cells are genetically modified to express a CAR designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.

Gazyva, meanwhile, attaches to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells, and is designed to attack and destroy targeted B cells both directly and in tandem with the body's immune system.

Roche was looking to expand on its already marketed indication in Gazyva as a first-line treatment for chronic lymphocytic leukaemia (CLL), as well as more recent approvals this year in another form of blood cancer, known as follicular lymphoma (FL).

This is a bigger blow to Roche in the longer term as it is expected to succumb to cheaper biosimilar pressure in the coming years to Rituxan (as well as most of its older cancer portfolio), and the company needed its new drug Gazyva to show it could better the older med to help at least in part protect against the coming sales erosion.

A couple of months ago, the drug did however beat Rituxan in a first-line setting in FL, which boosted its shares.

Sandra Horning, CMO and head of global product development at Roche, said: “We will continue to analyse 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.”

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