SHERIDAN, WYOMING – May 27, 2025 – Roche has unveiled compelling two-year follow-up data from its pivotal phase III STARGLO trial, reinforcing the long-term clinical value of Columvi® (glofitamab) in combination with chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The results underscore the strategic impact of Roche’s bispecific antibody pipeline in addressing aggressive hematologic malignancies with limited treatment options.
Landmark Survival Benefit in R/R DLBCL
The updated STARGLO data show a 40% improvement in overall survival for patients treated with Columvi plus GemOx (gemcitabine and oxaliplatin), compared to the control arm receiving MabThera®/Rituxan® (rituximab) with GemOx. Notably, the median overall survival for the Columvi arm was not reached, versus 13.5 months in the comparator group.
Further findings demonstrated:
- A 59% reduction in risk of disease progression or death (hazard ratio = 0.41; 95% CI: 0.29–0.58)
- Over twice the rate of complete response (58.5% vs. 25.3%)
- 89% of complete responders remained alive one year after treatment
- 82% remained in remission one year post-treatment
Clinical Experts Emphasize Rapid Access and Durability
“We are encouraged that the two-year follow-up data for Columvi reinforces its potential to extend the lives of many patients where prognosis has historically been poor,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development.
Haifaa Abdulhaq, MD, Professor at UCSF and Director of Hematology at UCSF Fresno, added: “In my community practice, I’ve seen the potential of this Columvi combination to help patients start treatment quickly – providing lasting remissions and more time without ongoing therapy.”
The data will be presented during an oral session at the American Society of Clinical Oncology (ASCO) Annual Meeting from May 30 to June 3, 2025.
A Global Standard in Second-Line DLBCL Care
Already approved in over 30 countries for second-line use in patients ineligible for autologous stem cell transplant (ASCT), Columvi’s combination regimen has been incorporated into the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology as a category 1 preferred recommendation.
The safety profile of the Columvi-GemOx regimen remains consistent with prior analyses. Though a higher incidence of adverse events, including cytokine release syndrome, was observed, most cases were low grade. Importantly, the higher number of treatment cycles in the Columvi group was driven by longer disease control.
Addressing a High-Unmet-Need Market
DLBCL affects roughly 160,000 patients annually worldwide, with up to 40% experiencing relapse or refractory disease after frontline treatment. Many of these patients cannot access or tolerate newer therapies, making an off-the-shelf and fixed-duration regimen a vital advancement.
The STARGLO study confirms Columvi’s strategic value in:
- Offering rapid, scalable treatment for relapsed patients
- Reducing dependence on intensive hospital infrastructure
- Extending remission durability without ongoing therapy
- Supporting early intervention in clinical decision-making
Roche’s Long-Term Vision in Hematology
Columvi is part of Roche’s expanding CD20xCD3 bispecific antibody program, which includes Lunsumio® and investigational regimens such as Polivy® plus R-CHP in previously untreated DLBCL. The SKYGLO study is currently evaluating Columvi’s role in first-line therapy settings.
Roche's hematology portfolio spans established products like Rituxan®, Gazyva®, Polivy®, Venclexta®, and Hemlibra®, with pipeline agents such as cevostamab and Tecentriq® further expanding its scope.
By leveraging its dual strengths in diagnostics and pharmaceuticals, Roche is uniquely positioned to tailor blood cancer treatments to evolving clinical needs and healthcare system capabilities.
Learn more at www.roche.com.