Findings further demonstrate the effectiveness of Roche’s approved medicines in advancing treatment standards for people with blood disorders Data from innovative pipeline signals progress toward improved outcomes in haemophilia A, lymphoma, and multiple myeloma Basel, 3 November 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will showcase 46 abstracts, including 12 oral presentations, from its industry-leading haematology portfolio at the 67th American Society of Hematology (ASH) Annua ...

Core Insights - Roche announced two-year follow-up data from the phase III STARGLO study, showing a 40% improvement in overall survival for patients treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) compared to MabThera®/Rituxan® (rituximab) plus GemOx [1][4] Group 1: Study Results - The median follow-up was 24.7 months, with overall survival not reached for the Columvi combination, while it was 13.5 months for the R-GemOx group [1] - The Columvi combination demonstrated a 59% reduction in the risk of disease progression or death (hazard ratio = 0.41, 95% confidence interval: 0.29–0.58) [2] - Among patients achieving complete remission (CR) at the end of treatment, 89% were alive and 82% maintained remission one year post-treatment [2][4] Group 2: Treatment Implications - Columvi is approved in over 30 countries for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant [3] - The combination of Columvi and GemOx has been added to the National Comprehensive Cancer Network Clinical Practice Guidelines as a category 1 preferred recommendation for second-line DLBCL treatment [3] - There is an urgent need for rapidly available treatments for DLBCL, as many patients do not have access to the latest therapies [2][9] Group 3: Safety and Efficacy - The safety profile of the Columvi combination remained consistent with previous analyses, with a higher rate of adverse events observed, including cytokine release syndrome, which was generally low grade [2][4] - Patients receiving the Columvi combination had a higher median number of treatment cycles (11 versus 4) due to disease progression in the R-GemOx arm [2] Group 4: Company Strategy - Roche is focused on developing tailored treatment options for blood cancers, including the CD20xCD3 bispecific antibody program, which includes Columvi and Lunsumio® [5][7] - The company is also investigating Columvi in combination with other therapies for previously untreated DLBCL in ongoing studies [8]

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]