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.
about the author
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.