Roche Reports Positive Phase 3 Results for Columvi Combo in DLBCL

Roche has announced compelling phase 3 trial results for its drug Columvi (glofitamab) combined with chemotherapy in treating patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This common type of non-Hodgkin lymphoma affects around 160,000 people globally each year. Unfortunately, about 40% of these patients will experience a relapse or have refractory disease, where treatment options are scarce and survival rates are low.

The ongoing STARGLO trial has been comparing the efficacy of Columvi against rituximab, both used in conjunction with gemcitabine and oxaliplatin (GemOX). Participants in the trial include DLBCL patients who are ineligible for an autologous stem cell transplant after one or more prior therapies, or those who have undergone at least two previous treatments.

The trial has successfully met its primary endpoint of overall survival (OS). Patients receiving the Columvi and GemOx combination had a significant improvement in survival, demonstrating a 41% reduction in the risk of death compared to those treated with rituximab and GemOx. Additionally, the safety profile of the Columvi combination was consistent with that of the individual drugs, ensuring that the treatment is viable from a safety perspective.

Moreover, the Columvi combination achieved its key secondary endpoint of progression-free survival (PFS), with a notable 63% reduction in the risk of disease progression or death when compared to the rituximab and GemOx combination. In subsequent analysis, the Columvi regimen continued to show advantages in both primary and secondary endpoints. Patients in the Columvi group had a median OS of 25.5 months, with 58.5% experiencing a complete response (CR). In contrast, the rituximab group had a median OS of 12.9 months and a 25.3% complete response rate.

Levi Garraway, Roche's chief medical officer and head of global product development, expressed optimism about the findings, stating that this is an important step towards advancing Columvi combinations in earlier treatment settings. He emphasized that the results could be particularly significant for patients with aggressive disease who are at high risk of rapid progression.

Columvi has already received accelerated approval from the US Food and Drug Administration and conditional marketing authorization from the European Commission for treating patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. The drug works by dual-targeting to activate the release of cancer cell-killing proteins from T-cells, providing a novel and effective approach to combat this challenging disease.

These promising results follow Roche's earlier announcement in April, confirming a statistically significant improvement in overall survival for the Columvi regimen compared to the rituximab combination. The new data further solidify Columvi's potential as a transformative treatment option for patients battling relapsed or refractory DLBCL.