Three-year follow-up results from a Phase III study (STARGLO) of glofitamab (brand name Columvi), a CD20xCD3 T-cell-engaging bispecific antibody (BsAb), suggest a durable survival advantage for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who cannot undergo autologous stem cell transplant, Roche announced on Dec. 8, 2025. After a median follow-up of 35.1 months, overall survival was twice as long in patients treated with glofitamab combined with gemcitabine and oxaliplatin compared with rituximab plus the same chemotherapy backbone (25.5 months versus 12.5 months; hazard ratio 0.60, 95% confidence interval 0.43–0.8), according to the company (1).

From an industry perspective, these findings are important because they reinforce the growing role of bispecific antibody–based regimens as “off-the-shelf” immunotherapies that can be manufactured, stored, and distributed using more conventional biologics infrastructure than patient-specific cell therapies (2). This advantage has implications for supply chain planning, hospital readiness, and scalability in hematologic oncology (3).

“By prolonging survival, this Columvi combination could offer people with relapsed or refractory DLBCL long-term remission, and potential additional time to spend with their loved ones without signs of disease or the need for continuous therapy,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development, in the release (1). “The potential of Columvi in combination with GemOx continues to be recognized globally, with approvals in more than 50 countries around the world and inclusion in multiple international treatment guidelines.”

What impact would off-the-shelf BsAb combos have on aggressive lymphomas?

Subgroup analyses in the study showed consistent benefit across age groups and prior lines of therapy. According to the company, the most pronounced effect was seen in patients treated in the second line setting, where 54.6% of patients remained alive at 36 months. In this group, median overall survival was not reached with glofitamab plus gemcitabine and oxaliplatin, compared with 14.4 months in the comparator arm. Median progression-free survival was 20.4 months versus 5.5 months, respectively. In patients with early relapse, a population historically difficult to treat, the complete response rate reached 56.0%, with a 36-month overall survival rate of 46.1% (1).

The clinical profile of this regimen represents a fixed-duration, pre-manufactured biologic therapy that does not depend on individualized production (4). That model contrasts with more complex personalized platforms and could lower barriers to global distribution, reduce manufacturing bottlenecks, and shorten treatment initiation timelines in real-world practice (1,4).

“At three years, we see flattening of the overall survival curve, suggesting the possibility of cure for relapsed/refractory DLBCL patients treated with glofitamab-GemOx,” said Jeremy Abramson, MD, director, Jon and Jo Ann Hagler Center for Lymphoma at the Mass General Brigham Cancer Institute, US, and principal investigator of the Phase III (STARGLO) study, in a company press release (1). “These data continue to underscore the meaningful benefit of glofitamab plus GemOx for patients after initial relapse, when fast and effective treatment is critical given the aggressive nature of this disease.”

Why do global approvals, guideline recommendations, and regulatory divergence matter for biopharma strategy and pipeline investment?

The glofitamab combination regimen has been approved in more than 50 countries, including the United Kingdom, Canada, Australia, China, Mexico, and countries in the European Union, and is included in multiple international clinical practice guidelines, according to Roche. At the same time, the company reported that FDA issued a complete response letter for the supplemental biologics license application for this indication, which highlights how regional regulatory decisions can diverge even with mature clinical datasets (1). For industry stakeholders, this regulatory divergence underscores the operational and strategic need to design development programs that can address differing regulatory expectations, especially when scaling manufacturing and commercial deployment (5).

From a manufacturing and development standpoint, the unchanged safety profile at extended follow-up supports more predictable production planning and pharmacovigilance frameworks. Cytokine release syndrome remained the most common adverse event, and immune recovery markers were observed 18–24 months after treatment completion (1). These elements influence how companies design risk management plans, process validation strategies, and post-marketing surveillance systems (6).

The broader impact of these study findings extends beyond a single product. The data add weight to a shift in the competitive landscape for hematologic oncology, where standardized, scalable immunotherapies are increasingly viewed as a balance between clinical performance and operational feasibility (1). This trend has implications for capacity planning in biologics manufacturing, investment in flexible fill-finish capabilities, and future pipeline prioritization across the industry (1,7).

Roche presented these data during the American Society of Hematology Annual Meeting and Exposition, occurring Dec. 6–9, 2025, in Orlando, Fla.

References

1. Roche. Roche’s Columvi Combination Shows Sustained Survival Benefit at Three-Year Follow Up of Pivotal Phase III STARGLO Study. Press Release. Dec. 8, 2025.
2. Omer, M. H.; Shafqat, A.; Ahmad, O.; et al. Bispecific Antibodies in Hematological Malignancies: A Scoping Review. Cancers (Basel) 2023, 15 (18), 4550. DOI: 10.3390/cancers15184550
3. Subklewe, M. BiTEs Better Than CAR T Cells. Blood Adv. 2021, 5 (2), 607–612. DOI: 10.1182/bloodadvances.2020001792
4. Hutchings, M.; Morschhauser, F.; Iacoboni, G.; et al. Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell–Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial. J. Clin. Oncol. 2021, 39 (18), 1959–1970. DOI: 10.1200/JCO.20.03175
5. Kirchlechner, T. M.; Cohen, H. P. Global Harmonization of Biosimilar Development by Overcoming Existing Differences in Regional Regulatory Requirements—Outcomes of a Descriptive Review. Ther Innov Regul Sci. 2025, 59 (2), 245–255. DOI: 10.1007/s43441-024-00740-4
6. Wagner, C. B.; Steinbach, M.; Verducci, D.; Kowalski, A. BCMA-Directed Bispecific Antibodies for Multiple Myeloma: Practical Approaches to Patient Management. JHOP 2025, 15 (4).
7. Abramsona, J. S.; Kub, M.; Gregory, G. P.; Fox, C. P. Glofitamab with GemOx for Diffuse Large B-Cell Lymphoma—Authors' Reply. Lancet 2025, 406 (10513), 1727–1728. DOI: 10.1016/S0140-6736(25)01583-1