Core Viewpoint - Roche's Columvi® (glofitamab) has received European Commission approval for use in combination with gemcitabine and oxaliplatin (GemOx) for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT) [1][2] Group 1: Approval and Clinical Significance - Columvi is the first bispecific antibody regimen available in Europe for DLBCL patients whose cancer has returned or who did not respond to initial treatment [1][2] - The approval is based on the pivotal phase III STARGLO study, which showed a 41% reduction in the risk of death for patients treated with Columvi plus GemOx compared to MabThera®/Rituxan® plus GemOx [2][3] - The study demonstrated a median overall survival (OS) of 25.5 months for Columvi-treated patients, nearly double the 12.9 months seen with R-GemOx [2][3] Group 2: Patient Population and Treatment Need - Approximately 38,000 people are diagnosed with DLBCL in Europe each year, with about 40% relapsing after first-line treatment [2][8] - Patients with relapsed or refractory DLBCL not eligible for ASCT represent a challenging population, highlighting the urgent need for effective therapies [2][3] - Columvi in combination with GemOx offers an "off-the-shelf" treatment option that is readily available for infusion, allowing for immediate treatment upon cancer recurrence [2][3] Group 3: Mechanism and Development - Columvi is a CD20xCD3 bispecific antibody designed to engage T cells and target B cells, enhancing the immune response against cancer cells [6][9] - Roche is also investigating Columvi in combination with other therapies for previously untreated DLBCL in the phase III SKYGLO study [7][9] - The company has a broad portfolio of hematology medicines and is committed to developing innovative treatment options for blood cancers [9][10]
European Commission approves Roche's Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy