Two-Year Study Update: Glofitamab (Columvi) with GemOx for Relapsed/Refractory DLBCL

Can a new treatment combination in a clinical trial extend the length of life for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)? 

On May 22, 2025, Genentech issued a press release sharing two-year updates for a study including glofitamab (Columvi) with GemOx for patients who are not eligible for a stem cell transplant. Learn the results below!

A Two-Year Look: Longer Life for Patients After Glofitamab + GemOx Treatment

The Phase III STARGLO study offers new data on glofitamab, a bispecific antibody therapy combined with chemotherapy, for people with relapsed or refractory DLBCL. After a follow-up of nearly 25 months, patients who received glofitamab with gemcitabine and oxaliplatin (GemOx) lived significantly longer compared to those who received rituximab with GemOx. The median overall survival was also improved by 40% in the group taking glofitamab.

Understanding this is key as DLBCL is an aggressive blood cancer, and for patients whose cancer returns or doesn’t respond to initial therapy, innovative therapies that extend patients' length of life are crucial. 

Most Patients Remained in Remission One Year After Treatment

Among patients whose cancer was not detected after finishing the glofitamab combination therapy, one year later, 89% were still alive and 82% remained cancer-free.

These remission rates are significant for people with relapsed/refractory DLBCL because maintaining remission means there is less need for continuous treatment, supporting patients to have a better quality of life.

Reduced Risk of Cancer Progression

The study also measured how long patients lived without their cancer worsening. Those treated with the glofitamab combination had a 59% lower risk of progression or death compared to the standard treatment. Additionally, 58.5% of patients had a complete response compared to only 25.3% in the control group.

This indicates that glofitamab with GemOx may not only help patients live longer but may also more effectively keep the cancer under control.

A Fixed-Duration Option Without the Need for Transplant

Glofitamab is described as an "off-the-shelf" treatment, which means it’s ready for immediate use and doesn’t require complex preparation like personalized cell therapies. Importantly, it is a fixed-duration therapy, so patients can complete treatment in a set timeframe rather than remaining on it indefinitely.

This is especially relevant for people who can’t undergo stem cell transplants due to age, health conditions, or lack of access. Having a time-limited treatment that still shows durable results supports patient autonomy and simplifies care planning.

Safety Profile and Side Effects to Know

As with any treatment, side effects from glofitamab and GemOx were reported in the trial. The most common was cytokine release syndrome (CRS), an immune system reaction that can include fever, chills, or shortness of breath. Most cases were mild. Neurological symptoms and infections also occurred in some patients.

Glofitamab is given through a carefully managed step-up dosing schedule to reduce the risk of CRS. Patients receive a pre-treatment and are monitored closely, especially during initial doses.

Understanding potential side effects can help you and your care team better prepare for treatment.

Is Glofitamab with GemOx FDA-approved? 

Glofitamab with GemOx is approved in over 30 countries for relapsed/refractory DLBCL patients not eligible for a stem cell transplant. Despite its recommendation as a second-line treatment, the combination is not yet FDA-approved.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) expressed concern that the STARGLO trial results were not fully applicable to U.S. patients with relapsed/refractory DLBCL due to limited U.S. enrollment and significant outcome differences across regions. The committee emphasized the importance of ensuring that data from global trials reflect U.S. standards of care and patient demographics before supporting regulatory approval. 

If you or a loved one is facing relapsed/refractory DLBCL and is not a candidate for a stem cell transplant, discuss treatment options with your DLBCL specialist. 

You can also create a HealthTree Cure Hub® account to access treatment options, explore clinical trials, and keep track of your health, all in one place! Click the button below to get started.

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Read additional articles on how glofitamab is being used in DLBCL care:

• Latest Advances in Glofitamab for LBCL
• Glofitamab (Columvi) to Treat Relapsed or Refractory DLBCL
• New Chemo-Free Trials for Relapsed/Refractory LBCL

Sources: 

• New Two-Year Follow-Up of Genentech’s Columvi Extends Overall Survival in Relapsed or Refractory Diffuse Large B-Cell Lymphoma Patients
• FDA ODAC Votes Against the Applicability of STARGLO Data for Glofitamab Plus Chemo for U.S. Patients With R/R DLBCL