Roche Gains Full European Commission Approval For Columvi Combination Therapy In Treating Diffuse large B-cell lymphoma (DLBCL)

Roche has received European Commission approval for Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This therapy is designed for patients who are not eligible for autologous stem cell transplant (ASCT). This marks the first bispecific antibody combination therapy available in Europe for patients whose cancer has returned or failed to respond to prior treatments. The approval also fulfills a requirement to convert Columvi's earlier conditional marketing authorisation to full approval status. 

“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 benefit patients even earlier in their treatment, adding to its value as an important treatment for DLBCL,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. 

The decision is based on positive results from the Phase III STARGLO trial, which showed that the Columvi-GemOx regimen significantly improved overall survival (OS) and progression-free survival (PFS) compared to rituximab-GemOx (R-GemOx). Specifically, the Columvi combo reduced the risk of death by 41% and the risk of disease progression or death by 63%. Median OS was 25.5 months for Columvi-treated patients versus 12.9 months for R-GemOx. Complete response rates were more than twice as high in the Columvi group (58.5% vs. 25.3%). The safety profile was consistent with the individual components of the combination therapy.

Franck Morschhauser, MD, PhD, Professor of Haematology, University Hospital Lille and STARGLO study investigator, stated, “People with R/R DLBCL not eligible for ASCT represent a challenging population, especially those with primary refractory disease or early relapse whose need for a readily accessible and effective therapy is insufficiently addressed globally. This new Columvi combination is immediately available if a patient’s cancer returns or doesn’t respond to first-line therapy, which is a welcome addition to manage DLBCL.”

DLBCL is the most common form of aggressive non-Hodgkin lymphoma in Europe, with 38,000 new cases diagnosed annually. A significant portion of patients relapse or are refractory to initial therapy, with limited options afterwards. The newly approved “off-the-shelf” Columvi + GemOx regimen is easily accessible and infused in various clinical settings. Designed for fixed-duration treatment, it offers patients the possibility of a treatment-free period, improving their quality of life. Columvi is part of Roche’s CD20xCD3 bispecific antibody program, along with Lunsumio®, aiming to provide innovative, accessible treatment options for blood cancer patients worldwide.