Roche Reports Three-Year Survival Gains with Columvi Combo in Relapsed DLBCL

Roche Reports Three-Year Survival Gains with Columvi Combo in Relapsed DLBCL

By, Admin 11 December 2025

Roche has released new three-year follow-up findings from its pivotal phase III STARGLO study, offering some of the strongest long-term evidence yet for Columvi (glofitamab) in relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The data was showcased at the 67th American Society of Hematology (ASH) Meeting in Orlando.

A Clear Survival Advantage After Three Years

Patients treated with Columvi + GemOx lived twice as long as those given rituximab + GemOx.

Key outcomes at 35.1 months:

  • Overall survival: 25.5 months vs 12.5 months
  • Hazard ratio: 0.60
  • Results remained consistent across age groups and prior treatments
  • The strongest benefit was seen in second-line patients

For people treated after only one prior therapy, more than half were still alive at 36 months.
Median overall survival in this group has not yet been reached, highlighting durable benefit.

Promising Outcomes in Hard-to-Treat Early Relapse

Patients who relapsed within 12 months—traditionally the hardest to treat—also showed strong responses.

  • Complete response rate: 56%
  • 36-month survival: 46.1%
  • Progression-free survival: 20.4 months vs 5.5 months with R-GemOx

These results suggest that the combination may deliver deeper, faster and more lasting disease control.

Experts See Signs of Potential Cure

Dr. Jeremy Abramson, principal investigator, noted that the survival curve is beginning to “flatten.” This is an early signal often associated with the potential for cure in aggressive lymphomas.

Roche leaders highlighted that the regimen offers long-term remission without continuous treatment. As an off-the-shelf, fixed-duration therapy, it can be deployed quickly in any infusion setting.

Safety Profile Remains Consistent

The extended follow-up revealed no new safety concerns.

  • Cytokine release syndrome occurred in 44.8% of patients
  • Most events were low-grade
  • B-cell and IgM recovery was seen 18–24 months after treatment

The safety profile matches what is already known about the individual medicines.

Approved in 50+ Countries—and Growing

Based on STARGLO’s evidence, Columvi + GemOx is now approved in more than 50 countries including:

  • EU
  • UK
  • Canada
  • China
  • Australia
  • Mexico

It is also recommended in leading guidelines from ESMO, EHA, and NCCN.

The FDA has issued a Complete Response Letter for the U.S. application, and Roche is working on next steps.

What’s Next for Columvi?

Roche is expanding its development plans to move Columvi earlier in care and into new lymphoma types.

Active trials include:

  • SKYGLO (Phase III): First-line DLBCL with Columvi + Polivy + R-CHP
  • GLOBRYTE (Phase III): Columvi monotherapy in relapsed mantle cell lymphoma

The goal is clear—establish Columvi-based regimens across multiple stages of aggressive B-cell cancers.

Why This Matters?

DLBCL is the most common aggressive lymphoma worldwide. Up to 40% of patients relapse, and options after the first relapse remain limited.

Columvi’s long-term results signal something rare: A chance at deep remission without continuous therapy. For many patients who cannot undergo stem-cell transplant, this could redefine what “hope” looks like.

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