Roche (SWX: RO), a leading Swiss pharmaceutical company, has announced that a late-stage clinical trial for its bispecific antibody Columvi (glofitamab) has successfully met its primary endpoint of overall survival (OS) in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The trial involved patients who had received at least one prior line of therapy and were not eligible for autologous stem cell transplant. The study compared the efficacy and safety of Columvi in combination with chemotherapy against the standard treatment of MabThera/Rituxan (rituximab) plus chemotherapy.
Columvi, a CD20xCD3 T-cell engager, has received conditional approvals in both Europe and the US for the treatment of r/rDLBCL in patients who have failed two or more lines of systemic therapy. Building on the positive results of this trial, Roche is now preparing to submit the data to health authorities with the aim of extending the indication for Columvi. – Flcube.com