Roche Seeks FDA Nod for Columvi Combo in Relapsed DLBCL Treatment

Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx).

Diffuse large B-cell lymphoma, the most common form of non-Hodgkin lymphoma, is a fast-growing cancer affecting approximately 160,000 people globally each year. Although initial treatments are often effective, many patients experience relapse or resistance, underscoring the importance of advancing therapeutic options to improve long-term outcomes.

This treatment targets individuals with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have undergone at least one prior therapy and are not eligible for autologous stem cell transplantation. A decision from the FDA is anticipated by 20 July 2025.

Current second-line treatments for R/R DLBCL typically involve high-dose chemotherapy followed by stem cell transplantation. However, not all patients can undergo this due to factors such as age or other health conditions, creating a need for alternative treatment options.

The sBLA submission is supported by findings from the phase III STARGLO study. Data from the study revealed that the Columvi and GemOx combination significantly improved overall survival compared to Rituxan® (rituximab) and GemOx (R-GemOx). This marks the first time a CD20xCD3 bispecific antibody has demonstrated a survival benefit in a randomised phase III trial for this condition.

The STARGLO study, conducted across multiple centres, compared the safety and effectiveness of the two treatment regimens in patients unsuitable for autologous stem cell transplantation. Results indicated a 41% reduction in the risk of death with the Columvi combination and a favourable safety profile consistent with the individual drugs. 

The most frequent adverse event was cytokine release syndrome, primarily low-grade and occurring in the initial treatment cycle.

The study's outcomes have also been submitted to global health authorities, including the European Medicines Agency, for regulatory review.

Columvi is part of Roche's portfolio of CD20xCD3 bispecific antibodies, which are designed to bring T-cells into proximity with B-cells, promoting targeted cancer cell destruction. Initially approved as a monotherapy for relapsed or refractory DLBCL after two or more systemic therapies, Columvi is now being explored in various combinations, including with Polivy® (polatuzumab vedotin) in untreated DLBCL patients.

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