Roche has received the European Commission (EC) conditional marketing authorisation for Columvi (glofitamab) to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adults, who previously received systemic therapy.
Columvi is a T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells.
It was engineered to have one region that binds to CD3, a protein on T-cells, a type of immune cell, and two regions that bind to CD20, a protein on B-cells, which can be healthy or malignant.
The dual-targeting property of the drug brings the T-cell located close to the B-cell and activates the release of cancer cell-killing proteins from the T-cell.
Columvi is currently being evaluated in an ongoing development programme, as a monotherapy and in combination with other medicines, for the treatment of B-cell non-Hodgkin lymphomas.
It is the first CD20xCD3 T-cell-engaging bispecific antibody available in Europe, to treat the most common and aggressive form of lymphoma, said the Swiss drugmaker.
Roche chief medical officer and global product development head Levi Garraway said: “As pioneers in the development of innovative T-cell-engaging bispecific antibodies, we are delighted that we can now offer Columvi as the first approved treatment of its kind to people in Europe.
“We are confident that thanks to its off-the-shelf availability, fixed-duration regimen and durability, Columvi will positively transform the treatment experience for relapsed or refractory diffuse large B-cell lymphoma.”
The EC approval is supported by positive results from a cohort in the Phase 1/2 NP30179 study, evaluating the safety, efficacy and pharmacokinetics of Columvi in people with R/R DCLBCL.
The Phase 1/2 study enrolled 83.3% of patients who were refractory to the most recent therapy, 90% to any previous line of therapy, and nearly one-third had received prior CAR T-cell therapy.
In the study, Columvi induced early and long-lasting responses in people with R/R DLBCL.
The drug-induced a complete response (CR) in 35.2% of people, as assessed by an independent review committee, which is the primary endpoint.
Also, the Columvi resulted in 50% of study participants achieving an overall response (OR), a secondary endpoint among others including, progression-free survival, safety, and tolerability.
The most common adverse events (AEs) were cytokine release syndrome, neutropenia, anaemia and thrombocytopenia.
Recently, Roche secured the US Food and Drug Administration (FDA) approval for Columvi to treat a type of R/R DLBCL in adult patients, after two or more lines of systemic therapy.
