MedPath

Odronextamab

Generic Name
Odronextamab
Brand Names
-
Drug Type
Biotech
Chemical Formula
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CAS Number
1801338-64-6
Unique Ingredient Identifier
8R5CM46UIO
Background

Odronextamab is a hinge-stabilized, fully human immunoglobulin G4 (IgG4)-based CD20×CD3 bispecific antibody currently evaluated for the treatment of relapsed/refractory (R/R) B-Cell non-Hodgkin lymphoma (NHL). Preliminary studies have shown that in patients with R/R NHL, the use of odronextamab does not lead to the development of neurologic toxicity; however, it can lead to the development of cytokine release syndrome (CRS), a serious condition associated with the use of immunotherapy. In December 2020, the FDA placed a partial clinical hold and requested the drug developer, Regeneron Pharmaceuticals, to amend clinical protocols to reduce the incidence of CRS. The partial clinical hold was later lifted in May 2021.

A phase I clinical study (NCT02290951) showed that in heavily pre-treated patients with B-cell non-Hodgkin lymphoma, odronextamab elicited a durable response with a manageable safety profile.

Associated Conditions
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Associated Therapies
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Clinical Trials
Related News
cancernetwork.com
·

Odronextamab Demonstrates Safety in Treating DLBCL Population

Odronextamab showed a manageable safety profile with primarily grade 1 or 2 cytokine release syndrome (CRS) in DLBCL patients, no grade 5 CRS or immune-effector cell-associated neurotoxicity syndrome (ICANS) cases, and 20% grade 3 or greater infection rate. A treatment-related death occurred due to COVID-19 pneumonia. The CAR-HEMATOTOX model identified patients at higher risk for infectious complications.

Related Clinical Trials:

Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies
pharmaceutical-technology.com
·

Regeneron's Ordspono faces challenges, but positive results signal hope

Regeneron's Ordspono shows promise in treating r/r MZL with 77.1% ORR and CR rate, but faces challenges like low long-term adherence and regulatory delays. It received EU approval for r/r FL and DLBCL, but US market adoption is pending confirmatory trials. Competitors like AbbVie and Genmab's Epkinly pose threats with more convenient administration routes.
biospace.com
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Odronextamab ASH Presentations Underscore Impressive Efficacy Across B-Cell Non-Hodgkin Lymphoma Subtypes

Odronextamab monotherapy showed complete responses in all evaluable patients with untreated follicular lymphoma in the OLYMPIA-1 trial. It also demonstrated efficacy in DLBCL post-CAR-T therapy and high response rates in relapsed/refractory marginal zone lymphoma, highlighting its potential across B-cell non-Hodgkin lymphoma subtypes.
marketscreener.com
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Odronextamab Ash Presentations Underscore Impressive Potential in Early Trials

Regeneron Pharmaceuticals presented odronextamab data at ASH, showing efficacy in Phase 3 OLYMPIA-1 trial with complete responses in 12/13 patients. Safety profile noted CRS, diarrhea, rash. ELM-1 trial showed 48% ORR in DLBCL post-CAR-T. ELM-2 trial in R/R MZL showed 77% ORR, all CRs. Odronextamab approved in EU for R/R FL/DLBCL, U.S. resubmission expected 2025.
stocktitan.net
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Regeneron's Odronextamab Shows Remarkable 100% Response Rate in Lymphoma

Odronextamab showed 100% complete response in untreated follicular lymphoma, 48% objective response in DLBCL post-CAR-T, and 77% complete response in relapsed/refractory marginal zone lymphoma. EU approval secured; U.S. resubmission planned for 2025.

Related Clinical Trials:

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 Participants With Follicular Lymphoma
A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma
A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma
A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma
A Trial to Learn 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
markets.businessinsider.com
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Regeneron announces new data from odronextamab trial at ASH

Regeneron presented odronextamab data at ASH, showing efficacy in B-cell non-Hodgkin lymphoma with complete responses in early trials. Phase 3 OLYMPIA-1 trial results and ELM-1 trial data highlighted significant response rates and safety profile. Odronextamab is EU-approved for R/R FL/DLBCL, with U.S. resubmission expected by 2025.
morningstar.com
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Odronextamab ASH Presentations Underscore Impressive Potential in Earlier Lines of Treatment and Additional Types of Lymphoma

Odronextamab monotherapy achieved complete responses in all evaluable patients with untreated follicular lymphoma in the OLYMPIA-1 trial. ELM-1 trial showed durable responses in DLBCL post-CAR-T therapy. ELM-2 trial demonstrated high complete response rates in relapsed/refractory marginal zone lymphoma. Presented at ASH 2024.
trial.medpath.com
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Odronextamab ASH Presentations Underscore Impressive Efficacy in Lymphoma Treatment

Odronnextamab data at ASH 2024 indicates efficacy in earlier treatment lines and various lymphomas, with complete responses in follicular lymphoma and durable responses in post-CAR-T diffuse large B-cell lymphoma.
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