EU Approves Roche's Columvi, First Bispecific Antibody for Post-Therapy DLBCL

In a significant development for cancer treatment, Roche announced that the European Commission has granted approval for Columvi® (glofitamab) to be used in conjunction with gemcitabine and oxaliplatin (GemOx) for adult patients suffering from relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This approval is particularly important for those who are not candidates for autologous stem cell transplant (ASCT). This combination therapy marks the introduction of the first bispecific antibody regimen for DLBCL patients in Europe whose disease has returned or who did not respond to initial treatments.

Columvi was previously granted conditional marketing authorization in July 2023 for patients with relapsed or refractory DLBCL after undergoing two or more systemic therapy lines. The recent approval satisfies conditions necessary to transition this to a regular approval. Roche’s Chief Medical Officer and Head of Global Product Development, Levi Garraway, highlighted that Columvi is the first of its kind to enhance survival outcomes for DLBCL patients whose disease relapsed after initial treatment. The new approval allows Columvi to be used earlier in the treatment process, underscoring its value as a vital therapy for DLBCL.

Franck Morschhauser, a Professor of Haematology at University Hospital Lille and an investigator in the STARGLO study, expressed that patients with R/R DLBCL who are not eligible for ASCT represent a challenging group, especially those with primary refractory disease or early relapse. The introduction of this new Columvi combination provides immediate treatment options if the cancer reoccurs or does not respond to first-line therapy.

The approval is rooted in findings from the pivotal phase III STARGLO study. In this study, the combination of Columvi with GemOx showed a significant and meaningful improvement in overall survival (OS) when compared to MabThera®/Rituxan® (rituximab) combined with GemOx (R-GemOx) in patients with relapsed or refractory DLBCL. The primary analysis conducted after a median follow-up of 11.3 months indicated a 41% reduction in the risk of death for patients treated with the Columvi combination compared to R-GemOx.

Furthermore, the Columvi regimen met key secondary endpoints, showing a 63% reduction in the risk of disease progression or death (progression-free survival, PFS) compared to R-GemOx. Subsequent analyses conducted after all patients completed therapy revealed a median OS of 25.5 months for those treated with the Columvi combination, almost double the 12.9 months observed with R-GemOx. Additionally, more than twice as many patients achieved a complete response with the Columvi regimen (58.5% versus 25.3%).

The safety profile of the combination was consistent with the known safety profiles of the individual medicines. DLBCL is a rapidly growing type of lymphoma, and it is one of the most common forms of blood cancer in adults. In Europe, approximately 38,000 new cases of DLBCL are diagnosed annually. The aggressive nature of the disease and the challenges in accessing existing medications highlight the urgent need for treatments that are readily available and can improve patient outcomes.

The Columvi and GemOx combination offers an off-the-shelf treatment option, easily accessible for infusion, which minimizes delays in starting the next treatment phase. Columvi is designed for fixed-duration therapy, providing patients with a clear endpoint and the possibility of a treatment-free period post-therapy.

Roche's focus on developing innovative treatments for blood cancers is reflected in its CD20xCD3 bispecific antibody program, which includes Columvi and Lunsumio® (mosunetuzumab). The company is committed to offering tailored treatment solutions that meet the diverse needs of patients and healthcare systems.