Roche’s Columvi, a bispecific antibody known as glofitamab, has been approved by the European Commission (EC) for use in combination with gemcitabine and oxaliplatin (GemOx) to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults who are not candidates for autologous stem cell transplants. DLBCL affects approximately 38,000 people in Europe annually, with many patients developing recurrent or resistant conditions following initial treatment.
Columvi is administered over a fixed period, offering patients treatment-free intervals and swift initiation post-diagnosis due to its readily available nature. The EC’s approval marks a transition from the conditional marketing authorization granted two years ago for patients with relapsed or refractory DLBCL after multiple lines of therapy.
The decision by the EC was driven by positive results from the phase 3 STARGLO trial, which demonstrated that the Columvi plus GemOx regimen significantly improved overall survival (OS) and decreased the risk of death by 41%, with a 63% reduction in the risk of disease progression or death compared to rituximab plus GemOx (R-GemOx). Follow-up data revealed a median OS of 25.5 months for the Columvi regimen, in contrast with 12.9 months for the R-GemOx group, alongside a higher rate of complete responses.
Levi Garraway, Roche’s Chief Medical Officer, emphasized Columvi’s unique role as the first treatment to enhance survival outcomes for DLBCL patients following initial therapy, highlighting its increasing value in the DLBCL treatment landscape.
In summary, Roche’s Columvi combined with GemOx offers significant progress in treating relapsed or refractory DLBCL, showing substantial survival improvements and establishing a new protocol for this patient population. The findings underscore Columvi’s effectiveness and potential as a critical option in the DLBCL therapeutic arsenal.
