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Promising Results For Treating DLBCL With Odronextamab
Posted: Oct 26, 2023
Promising Results For Treating DLBCL With Odronextamab image

The Food and Drug Administration (FDA) has recently announced the Priority Review of “odronextamab to treat adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies.” Priority Review means that the FDA aims to take action on a drug application within six months, compared to 10 months under standard review. This accelerated review is supported by data from the phase 1 ELM-1 and the phase 2 ELM-2 trial. March 31, 2024 is the FDA target decision date for the possible approval of odronextamab.

Odronextamab is an off-the-shelf CD20×CD3 bispecific antibody, meaning that it binds to a cell surface protein called CD3 on T cells and CD20 on B cells, triggering T‐cell‐mediated cell death of the cancerous DLBCL cells. This drug is given intravenously. 

Positive Results So Far

  • In the Phase 1 ELM-1 study, odronextamab given by itself showed a manageable safety profile and encouraging antitumor activity, including durable responses in heavily pretreated patients with DLBCL
  • In the Phase 2 ELM-2 study, patients with relapsed/refractory DLBCL who had not received CAR T-cell therapy had an objective response rate (ORR) of 49% and a complete response (CR) rate of 31%. The median duration of complete response was 18 months 
  • In the Phase 2 ELM-2 study, for patients who had received prior CAR-T therapy, 48% ORR was achieved and 32% CR was reached
  • Odronextamab has shown encouraging activity when used at doses >80mg for patients before or after CAR-T treatment

Odronextamab Side Effects

Safety among patients has also been evaluated. Some of the adverse effects were as follows:

  • 56.5% experienced cytokine release syndrome (CRS), an acute systemic inflammatory syndrome characterized by fever and multiple organ dysfunction, that is associated with chimeric antigen receptor (CAR)-T cell therapy, therapeutic antibodies, and haploidentical allogeneic transplantation
  • 40% experienced neutropenia, lower than normal neutrophils in your body 
  • 31% experienced a high fever
  • Anemia occurred in 30%
  • Joint stiffness and diarrhea occurred in 21%
  • 20% experienced a low platelet count

An Encouraging Future

"The Phase 1 and pivotal Phase 2 odronextamab data demonstrated deep and durable responses that were consistent in patients who progress after CAR-T therapy, which is important as they have particularly difficult-to-treat disease and no effective treatment options. Coupled with its overall safety profile, these clinically important results reinforce the potential of odronextamab to treat this aggressive blood cancer."

The ELM-1 and ELM-2 studies are still ongoing. Regeneron, the pharmaceutical company developing odronextamab, states that they are also initiating a broad Phase 3 development program to investigate odronextamab in earlier lines of therapy and other types of non-Hodgkin lymphomas, representing one of the largest clinical programs in lymphoma.

The author Lisa Foster

about the author
Lisa Foster

Lisa Foster is a mom of 3 daughters, a puzzle lover, a writer, and a HealthTree advocate. She believes in the mission of the foundation and the team that builds it forward. She calls Houston, Texas home. 

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