New Bispecific Antibody Odronextamab Updates for Relapsed Follicular Lymphoma

Learn how a new bispecific antibody called odronextamab (Regeneron) supported people with relapsed or refractory follicular lymphoma in a clinical trial. See what the results may mean for your care.   

How odronextamab works for refractory follicular lymphoma

Follicular lymphoma is a slow-growing type of lymphoma. Many people respond well to their first treatment. Over time, the lymphoma may come back or stop responding. This is called relapsed or refractory lymphoma.

Each new treatment may work for a shorter time. This is why new treatment options are still needed, especially for people who have already tried several therapies.

Odronextamab is a bispecific antibody. This type of treatment can connect two different cells. It links T cells, which fight infection, to lymphoma cells. This helps the immune system find and remove cancer cells.

This approach is different from standard treatments. It uses the body’s immune system in a more direct way.

How effective was odronextamab in the study?

The ELM-2 study included 128 people with relapsed or refractory follicular lymphoma. All had received several prior treatments. Key results showed:

• 80% experienced an objective response, meaning the lymphoma shrank
• 73% experienced a complete response, meaning no lymphoma was seen on scans
• Median progression-free survival was 20.7 months

The median is the midpoint. This means that half of the patients were alive without cancer progression for less than 20.7 months, and the other half for more than 20.7 months. 

These results suggest this treatment may help control lymphoma for a meaningful period, even after other options have stopped working.

What patients reported about quality of life

Researchers also studied health-related quality of life. This includes how people feel physically, emotionally, and socially. Findings showed:

• Overall quality of life stayed stable
• Emotional well-being improved over time
• Symptoms like fatigue and pain stayed low for many people
• Most people reported few issues from side effects

These results suggest people may be able to continue daily activities while on treatment, with stable or improved well-being.

Possible side effects of odronextamab

Like all treatments, odronextamab can cause side effects. The most common included:

• Cytokine release syndrome (CRS), which can cause fever and flu-like symptoms
• Low white blood cell counts (neutropenia), which can raise infection risk 

Most CRS cases were mild and happened early in treatment. They often improved without serious problems.

There was also a higher risk of infections, especially in people who had many prior treatments. Care teams can closely monitor patients to provide support against side effects. 

How odronextamab is given

Odronextamab is given through an intravenous (IV) infusion in cycles. The dose is increased slowly at the start to lower side effect risk.

Treatment can continue as long as it is working and tolerated. Some people with strong responses were able to switch to less frequent dosing. 

This flexible approach may help balance effectiveness with convenience over time.

Why the odronextamab FDA approval is still pending

Odronextamab is approved in Europe but is still under review in the United States by the U.S. Food and Drug Administration. The FDA issued a complete response letter in March 2024. This means more information is needed before approval.

The FDA did not raise concerns about how well the treatment works or its safety. The delay was linked to site inspection findings. These can include how trial data was recorded and whether study sites followed proper steps. These steps are part of making sure the data is reliable before approval.

Although the biologics license application was resubmitted in February 2025, the FDA is waiting for more findings from clinical trials testing odronextamab for people with relapsed or refractory follicular lymphoma. 

Summary

For people with relapsed or refractory follicular lymphoma, odronextamab showed strong response rates and helped maintain patients’ quality of life in a clinical trial. Side effects were manageable for many people. This treatment may offer another option for patients who have limited choices after prior therapies. 

If you want to see if you may qualify for odronextamab in a clinical trial, review the recruiting studies below. You can also talk with your follicular lymphoma specialist about treatment options and clinical trials.

• A Compassionate Use (CU) Program of Odronextamab
• Odronextamab in Low Tumor Volume Advanced Follicular Lymphoma
• A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma (OLYMPIA-1)
• A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)
• Odronextamab for Relapsed and Refractory Large B-cell Lymphomas Before CAR-T 

Sources: 

• Health-Related Quality of Life With Odronextamab Monotherapy for Relapsed/Refractory Follicular Lymphoma in the ELM-2 Study
• Bispecific Antibody Shows Deep Remission in Patients With Relapsed/Refractory Follicular Lymphoma
• FDA Issues CRL for Odronextamab in Relapsed/Refractory Follicular Lymphoma