FDA Accepts Roche’s Columvi Combo Application for Relapsed/Refractory Large B-cell Lymphoma

Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Columvi® (glofitamab) used in combination with gemcitabine and oxaliplatin (GemOx). This combination therapy is intended for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have undergone at least one prior therapy and are not suitable candidates for autologous stem cell transplant. The FDA's decision regarding approval is anticipated by July 2025.

Historically, the standard second-line treatment for R/R DLBCL patients has involved high-dose chemotherapy followed by stem-cell transplant. However, not all patients are eligible due to age or other medical conditions. Despite the availability of newer therapies, many patients still face barriers, necessitating alternative treatment options to improve survival outcomes.

Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, highlighted the importance of timely and effective therapies for aggressive lymphomas like DLBCL to mitigate the risk of disease progression and enhance long-term outcomes. Garraway expressed optimism about the overall survival benefit observed with the Columvi combination and its potential as an important treatment option for those in need of alternatives.

The sBLA submission is supported by data from the phase III STARGLO study, which demonstrated that Columvi combined with GemOx resulted in a statistically significant and clinically meaningful improvement in overall survival compared to rituximab plus GemOx (R-GemOx). This makes Columvi the first CD20xCD3 bispecific antibody to show a survival benefit in a randomized phase III trial for DLBCL.

The safety profile of the Columvi and GemOx combination was consistent with the known safety profiles of the individual drugs. Data from the STARGLO study have also been submitted to other health authorities worldwide, including the European Medicines Agency, for approval consideration.

Columvi is a part of Roche’s extensive CD20xCD3 bispecific antibody program, which has treated over 3,000 patients in clinical trials and more than 2,600 in clinical practice. Columvi was the first fixed-duration bispecific antibody to receive accelerated approval from the U.S. FDA and conditional marketing authorization in the EU for treating R/R DLBCL after two or more lines of systemic therapy. It is currently approved in over 50 countries.

As part of its efforts to enhance treatment standards in the early stages of DLBCL, Roche is also investigating Columvi in combination with Polivy® (polatuzumab vedotin), rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) in a phase III study called SKYGLO for previously untreated DLBCL.

The STARGLO study is a significant phase III, multi-center, open-label, randomized trial evaluating the efficacy and safety of Columvi in combination with GemOx versus R-GemOx in patients with R/R DLBCL. The primary analysis, conducted after a median follow-up of 11.3 months, showed that patients treated with the Columvi combination had a 41% reduction in the risk of death compared to those treated with R-GemOx. The median overall survival was not reached with the Columvi regimen, while it was nine months for R-GemOx.

Columvi, a CD20xCD3 T-cell engaging bispecific antibody, targets CD3 on T-cells and CD20 on B-cells, facilitating the release of cancer cell-killing proteins from the T-cells. Roche's bispecific antibody program also includes Lunsumio® (mosunetuzumab), aiming to provide tailored treatment options for blood cancers.

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma, making up about one-third of cases. It is a fast-growing form of lymphoma, and while it responds well to initial treatments, about 40% of patients will relapse or have refractory disease. Improving early treatment options and providing alternatives is crucial to improving long-term outcomes for these patients. Around 160,000 people globally are diagnosed with DLBCL each year.

Roche has been developing treatments for blood diseases for over 25 years and continues to invest in innovative therapies. Its approved medicines portfolio includes several key drugs for various hematologic conditions, and its pipeline continues to grow with new investigational medicines. Founded in 1896, Roche remains committed to advancing healthcare through scientific excellence and developing innovative treatments and diagnostics.