Glofitamab combined with chemotherapy brings new hope to patients with relapsed and refractory B-cell lymphoma

2024 In April, Roche announced its innovative bispecific antibody drug Glofitamab (Glofitamab, trade nameColumvi) Obtained formal approval from the European Commission for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who are not suitable for autologous stem cell transplantation (ASCT). This approval not only provides patients with a new treatment path, but also becomes the first approved bispecific antibody combination therapy in Europe for DLBCL a tumor type with a high recurrence rate.

Geffetuzumab received conditional marketing authorization from the EU as early as 2023 for the treatment of relapsed or refractory DLBCL after failure of two or more systemic treatments. The formal approval of the EU means that the efficacy and safety of the Columvi combination treatment regimen have been more fully supported by data, meeting all the requirements from conditional marketing to routine marketing.

DLBCL is a subtype of non-Hodgkin lymphoma that starts quickly and progresses rapidly, accounting for nearly one-third of all NHL cases. Although current first-line treatments such as R-CHOP can bring about a certain remission rate, there are still about 40% of patients who will relapse or become resistant to treatment after initial treatment. For these people, the treatment options are very limited, and the survival prognosis is poor.

Graftuzumab is a bispecific antibody targeting CD20 and CD3 via 2:1 structure simultaneously connects B cells and T cells, thereby activating T cells to exert their killing function against tumor cells. Its structure contains two binding sites for CD20 and one binding site for T cellsCD3 pan> site, this design can effectively promote T cells to approach and destroy malignant B cells, improving tumor clearance efficiency.

The approval of this indication expansion is based on the data from the III phase STARGLO clinical trial (NCT04408638). The study combined Columvi with gemcitabine plus oxaliplatin (GemOx) and compared it with standard therapy R-GemOx. The study subjects are patients with relapsed/refractory DLBCL who have received at least first-line treatment but are not suitable for transplantation, or who have received more than two lines of treatment. Research results show that Columvi combined with GemOx significantly prolonged overall survival (OS), the risk of death was reduced by 41% after a median follow-up of 11.3 months. Additionally, the risk of disease progression or death (PFS) was reduced by 63%.

The final follow-up data showed that the median overall survival of patients treated with Columvi reached 25.5 months, nearly twice that of the control group (12.9 months). In terms of response rate, the complete response rate of the Columvi treatment group was 58.5%, which was also significantly better than the 25.3% of the R-GemOx group. In terms of safety, the combination treatment was well tolerated, with no new serious adverse reactions, and was basically in line with the known safety characteristics of the drug.

This progress represents the gradual realization of the clinical value of bispecific antibodies in the treatment of hematological tumors, and may provide broader application prospects in the treatment of more relapsed and refractory lymphomas in the future.

References:European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy. Retrieved April 14, 2025.