Roche has revealed promising outcomes from its Phase III STARGLO study, showcasing significant advancements in treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) with Columvi (glofitamab). This study, conducted in collaboration with the Jon and Jo Ann Hagler Center for Lymphoma at the Massachusetts General Hospital Cancer Center, demonstrates that Columvi, when combined with gemcitabine and oxaliplatin (GemOx), significantly extends survival compared to the conventional Rituximab with GemOx (R-GemOx) treatment.

Significant Survival Benefits

The STARGLO study met its primary endpoint of overall survival (OS), where patients treated with the Columvi plus GemOx combination experienced a 41% reduction in the risk of death compared to those receiving R-GemOx. This was confirmed through a median follow-up of 11.3 months, with median OS not yet reached for the Columvi regimen, contrasting sharply with the nine months observed for R-GemOx. The study’s results were compelling enough to be featured in a late-breaking oral presentation at the European Hematology Association (EHA) 2024 Congress.

Additional Findings and Future Directions

Further analysis with a median follow-up of 20.7 months continued to highlight the robustness of the primary and secondary outcomes. Patients on the Columvi combination exhibited a median OS of 25.5 months and saw significant improvements in disease worsening or death, with a 63% reduction in risk compared to R-GemOx. These findings underscore the potential of CD20xCD3 bispecific antibodies like Columvi to transform the treatment landscape for DLBCL, particularly for those ineligible for autologous stem cell transplant.

Exploratory Analyses and Safety Profile

The study also undertook pre-specified exploratory subgroup analyses which showed consistency across different lines of therapy and outcomes of the last therapy. However, regional inconsistencies warrant cautious interpretation due to the exploratory nature of these analyses. Adverse events were manageable, with cytokine release syndrome being the most common but generally low-grade.

Jeremy Abramson, M.D., Director at the Jon and Jo Ann Hagler Center for Lymphoma and principal investigator of the STARGLO study, remarked, “The results from STARGLO are the first to show the potential of a CD20xCD3 bispecific antibody to make a difference in second or later-line DLBCL in people who are ineligible for transplant and have limited options.” Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer, also highlighted the significance of these results in providing a fixed-duration treatment option, which is particularly crucial for patients with aggressive disease progression.

Regulatory and Clinical Roadmap

Results from the STARGLO study are set to be submitted to global health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), aiming for full approvals for Columvi for R/R DLBCL treatment after two or more lines of systemic therapy. Additionally, Columvi’s potential is being explored in other aggressive, hard-to-treat lymphomas and has recently received Breakthrough Therapy Designation by the FDA for mantle cell lymphoma.

Roche’s Columvi presents a promising advancement in the treatment of DLBCL, offering hope and a potential new standard of care for patients facing this challenging cancer. Its success in clinical trials sets the stage for broader application and potential approval, aiming to meet the urgent needs of patients with limited treatment options.

  breakthrough therapies, Columvi, DLBCL treatment, hematological cancers, Phase III STARGLO study, Roche