Odronextamab treatment leads to deep and durable responses in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), according to data from a phase 1 and pivotal phase 2 clinical trial. These responses are consistent in patients whose disease progresses after CAR-T therapy. 

According to the trial investigator Won Seog Kim, MD, PhD, from the Samsung Medical Center and Division of Hematology-Oncology at Sungkyunkwan University in Seoul, South Korea, this is important as these patients’ disease is particularly difficult to treat and there are no effective treatment options available to them, the researchers noted. “Coupled with its overall safety profile, these clinically important results reinforce the potential of odronextamab to treat this aggressive blood cancer,” Dr. Kim said. 

Read more about the treatment of DLBCL

The results that were presented at the 64th American Society of Hematology Annual Meeting and Exposition showed that odronextamab led to a 49% objective response rate and a 31% complete response rate among patients not previously treated with CAR-T therapy and a 48% overall response rate and 32% complete response rate among those who previously received CAR-T therapy.

The results also showed that adverse events occurred in almost all (99%) of the 140 patients who were assessed for safety. Of these, 79% were grade 3 or higher. However, only 10% of patients discontinued treatment due to adverse events.

Regeneron Pharmaceuticals is now working on initiating a phase 3 clinical trial to investigate the treatment in earlier stages of the disease.

Odronextamab is a human IgG4-based CD20×CD3 bispecific antibody. It binds to CD3, a T-cell antigen associated with the T-cell receptor complex, and CD20, a B-cell surface antigen found on normal B cells and several malignancies of the B-cell lineage. This way, odronextamab mediates the directed killing of CD20+ cells by T-cells.


Pivotal odronextamab (CD20xCD3) phase 2 data in patients with relapsed/refractory diffuse large B-cell lymphoma debut at ASH. News release. Regeneron Pharmaceuticals; December 11, 2022.