Roche’s Columvi (glofitamab) has been approved by the European Commission (EC) as part of a combination treatment for diffuse large B-cell lymphoma (DLBCL).
The CD20xCD3 T-cell engaging bispecific antibody has been authorised alongside gemcitabine and oxaliplatin (GemOx) to treat adults with relapsed or refractory DLBCL not otherwise specified who are not candidates for an autologous stem cell transplant.
Approximately 38,000 people in Europe are diagnosed annually with DLBCL, an aggressive form of non-Hodgkin lymphoma.
Despite DLBCL being generally responsive to treatment in the frontline, 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 fixed period, providing patients with 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 was granted conditional marketing authorisation by the EC in 2023 to treat patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. Alongside the new approval, a condition to convert the existing marketing authorisation to a regular approval has been fulfilled.
The EC’s latest decision was supported by positive results from the phase 3 STARGLO trial, in which Columvi plus GemOx demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to rituximab plus GemOx (R-GemOx).
The Columvi combination was associated with a 41% reduction in the risk of death and a 63% reduction in risk of disease worsening or death compared to R-GemOx.
Follow-up analyses also showed a 25.5 month median OS for patients treated with the Columvi regimen compared to 12.9 months for the R-GemOx group, and more than twice as many patients receiving Roche’s combination experienced a complete response.
The company’s chief medical officer and head of global product development, Levi Garraway, said: “Columvi is the first treatment of its kind to improve survival outcomes for people with DLBCL whose cancer has returned after first-line therapy.
“With this approval, Columvi can now benefit patients even earlier in their treatment, adding to its existing value as an important treatment for DLBCL.”