Health Canada Approves Glofitamab Plus Chemotherapy for R/R DLBCL

Health Canada has approved glofitamab (Columvi) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are not candidates for autologous stem cell transplant (ASCT).¹

The decision makes glofitamab the first bispecific antibody regimen available in Canada for patients with DLBCL whose disease has returned or has not responded to initial therapy. The approval is supported by findings from the phase 3 STARGLO trial (NCT04408638), in which glofitamab plus GemOx generated significant improvements in overall survival (OS) compared with rituximab (Rituxan) plus GemOx.

“DLBCL is an aggressive and life-threatening form of lymphoma, leaving many patients in urgent need of additional treatment options,” Antonella Rizza, chief executive officer of Lymphoma Canada, stated in a news release. “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.”

Previously Reported FDA Status of Glofitamab in DLBCL

Notably, in July 2025, the FDA issued a complete response letter (CRL)to the supplemental biologics license application seeking the approval of glofitamab-gxbm plus GemOx for the treatment of patients with relapsed/refractory DLBCL who have received 1 or more prior lines of therapy and are not eligible to undergo ASCT.² The CRL noted that the STARGLO data were not sufficient to support the regimen’s approval for the United States population.

Efficacy and Safety Data From the STARGLO Study

At the primary analysis, with a median follow-up of 11.3 months, patients who received glofitamab plus GemOx achieved a 41% reduction in the risk of death compared with those treated with rituximab (Rituxan) plus GemOx (HR, 0.59; 95% CI, 0.40-0.89; P = .011). Furthermore, at an updated analysis, at a median follow-up of 20.7 months, the median OS was 25.5 months with the glofitamab combination vs 12.9 months with rituximab plus GemOx (HR, 0.62; 95% CI, 0.43-0.88).

Outcomes with key secondary end points also favored the glofitamab regimen. Patients who received glofitamab plus GemOx achieved a 63% reduction in the risk of progression or death (HR, 0.37; 95% CI, 0.25-0.55; P < .001).

Additionally, updated data from STARGLO presented at the 2025 ASCO Annual Meeting showed an overall response rate of 68.3% (95% CI, 61.0%-75.0%) in the glofitamab arm vs 40.7% (95% CI, 30.5%-51.5%) in the rituximab arm.³Complete responses (CRs) were observed in 58.5% (95% CI, 51.0%-65.7%) of patients treated with glofitamab plus GemOx vs 25.3% (95% CI, 16.8%-35.5%) of patients treated with rituximab plus GemOx (difference, 33.2%; 95% CI, 20.9%-45.5%).^1,3 Among complete responders in the glofitamab arm, the median duration of CR was not evaluable (NE; 95% CI, 27.2 months-NE), and at data cutoff, 42.1% of patients remained in CR.³ These respective values were 24.4 months (95% CI, 6.9-NE) and 17.6% in the rituximab arm.

Updated survival data showed that at a median follow-up of 24.7 months, the median OS in the glofitamab arm was NE (95% CI, 19.2-NE) compared with 13.5 months (95% CI, 7.9-18.5) in the rituximab arm (HR, 0.60; 95% CI, 0.42-0.85; P = .003). The 24-month OS rates were 54.4% and 33.6% in these respective arms. The median progression-free survival was 13.8 months (95% CI, 8.8-30.0) with the glofitamab regimen vs 3.6 months (95% CI, 2.5-7.1) with the rituximab regimen.

The safety profile of glofitamab plus GemOx was consistent with that of the individual agents, and no unexpected adverse effects were reported.¹

References

1. Health Canada approves Roche’s Columvi (glofitamab) as the first bispecific antibody in Canada for relapsed or refractory diffuse large B-cell lymphoma after initial therapy. News release. Roche Canada. August 21, 2025. Accessed August 21, 2025. https://www.rochecanada.com/media/health-canada-approves-roche-s-columvi-glofitamab-as-the-first-bispecific-antibody-in-canada-for-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-after-initial-therapy
2. Genentech provides update on supplemental biologics license application for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma. News release. Genentech. July 18, 2025. Accessed August 22, 2025. https://www.businesswire.com/news/home/20250718250985/en/Genentech-Provides-Update-on-Supplemental-Biologics-License-Application-for-Columvi-Combination-for-People-With-Relapsed-or-Refractory-Diffuse-Large-B-cell-Lymphoma
3. Abramson JS, Ku M, Hertzberg M, et al. Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 2-year (yr) follow-up of STARGLO. J Clin Oncol. 2025;43(suppl 16):7015. doi:10.1200/JCO.2025.43.16_suppl.7015