Roche has shared positive results from a late-stage study of its CD20xCD3 bispecific antibody Columvi (glofitamab) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The phase 3 STARGLO trial has been evaluating the drug against rituximab, both in combination with gemcitabine plus oxaliplatin, in DLBCL patients who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant.
The Columvi regimen demonstrated a statistically significant improvement in overall survival compared to the rituximab combination and its safety appeared consistent with the known profiles of the individual medicines.
Approximately 160,000 people worldwide are diagnosed annually with DLBC, the most common form of non-Hodgkin’s lymphoma.
While the disease is generally responsive to treatment in the frontline, Roche outlined that as many as 40% of patients will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.
Columvi is given for a defined period of time, giving patients a target end date for their course of treatment as well as the possibility of treatment-free periods. It is also designed to be off-the-shelf, meaning that treatment can begin soon after diagnosis.
The drug has already been granted accelerated approval by the US Food and Drug Administration and conditional marketing authorisation from the European Commission to treat patients with relapsed or refractory DLBCL after two or more lines of systemic therapy.
These decisions were based on positive results from a cohort of the phase 1/2 NP30179 study, which evaluated a fixed course of Columvi patients with DLBCL who had relapsed or were refractory to prior therapies, including about one-third who had received prior CAR T-cell therapy.
Commenting on the STARGLO results, Levi Garraway, Roche’s chief medical officer and head of global product development, said: “People with this aggressive lymphoma facing relapse or progression after initial treatment have limited options – particularly those who are ineligible for stem cell transplant.
“Building on Columvi’s established benefits, this data demonstrates the potential of this combination regimen to improve survival outcomes in earlier lines of treatment.”