Health Canada Authorizes Glofitamab with Chemotherapy for DLBCL

Health Canada has granted approval for the use of glofitamab (Columvi) in combination with gemcitabine and oxaliplatin (GemOx) for adult patients suffering from relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, particularly those who are ineligible for autologous stem cell transplant (ASCT). This marks a significant development as glofitamab becomes the first bispecific antibody regimen available in Canada specifically targeting this patient population.

The approval is based on results from the phase 3 STARGLO trial (NCT04408638), which demonstrated that the combination of glofitamab and GemOx significantly improved overall survival (OS) compared to the standard treatment with rituximab (Rituxan) plus GemOx. The findings underscore the urgent need for effective therapies for a disease known for its aggressive nature.

Clinical Trial Results Highlight Glofitamab’s Efficacy

In the STARGLO trial, patients receiving glofitamab alongside GemOx saw a 41% reduction in the risk of death when compared to those treated with rituximab and GemOx. This was reflected in the hazard ratio of 0.59 (95% CI, 0.40-0.89; P = .011). The median OS was reported at 25.5 months for the glofitamab cohort, versus just 12.9 months for the rituximab group at an updated analysis with a median follow-up of 20.7 months.

Key secondary endpoints also favored the glofitamab regimen. Patients treated with this combination achieved a 63% reduction in the risk of disease progression or death (HR, 0.37; 95% CI, 0.25-0.55; P < .001). During the 2025 ASCO Annual Meeting, updated data revealed an overall response rate of 68.3% for the glofitamab arm, compared to 40.7% for the rituximab arm.

The trial reported complete responses (CRs) in 58.5% of patients treated with the combination therapy, contrasting with only 25.3% in the rituximab group. Among those achieving CR in the glofitamab cohort, the median duration of response remained unmeasurable due to ongoing responses at the data cutoff, with a notable 42.1% still in CR.

Regulatory Landscape and Future Opportunities

Despite the positive results in Canada, the landscape in the United States remains uncertain. In July 2025, the FDA issued a complete response letter to the supplemental biologics license application for glofitamab combined with GemOx. The agency noted that the data from the STARGLO trial were insufficient to support approval for patients in the U.S. who have undergone one or more prior lines of therapy and are not eligible for ASCT.

Commenting on the approval, Antonella Rizza, chief executive officer of Lymphoma Canada, emphasized the critical need for new treatment options for patients facing DLBCL. She stated, “DLBCL is an aggressive and life-threatening form of lymphoma, leaving many patients in urgent need of additional treatment options. The availability of novel therapies has the potential to address critical gaps in care and offer new possibilities for patients who face relapse or have limited options.”

In conclusion, the approval of glofitamab in Canada opens doors for innovative treatment strategies in DLBCL, highlighting the ongoing efforts to advance cancer care. As research continues, the global medical community remains watchful for developments pertaining to the use of glofitamab in other markets, particularly the United States.