Odronextamab
- Generic Name
- Odronextamab
- Brand Names
- -
- Drug Type
- Biotech
- Chemical Formula
- -
- 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
- -
- Associated Therapies
- -
Odronextamab ASH Presentations Underscore Impressive Potential in Earlier Lines of Treatment and Additional Types of Lymphoma
Odronextamab showed complete responses in untreated follicular lymphoma patients in the OLYMPIA-1 trial. ELM-1 trial data highlighted efficacy in DLBCL post-CAR-T therapy, with a 48% ORR. ELM-2 trial demonstrated a 77% ORR in relapsed/refractory marginal zone lymphoma. Presented at ASH 2024, these findings underscore odronextamab's potential across B-NHL subtypes.
Odronextamab ASH Presentations Underscore Impressive Results in B-cell Non-Hodgkin Lymphoma Treatment
Odronextamab shows promising results in treating various B-cell non-Hodgkin lymphoma subtypes, including complete responses in untreated follicular lymphoma and durable responses in diffuse large B-cell lymphoma post CAR-T therapy. High complete response rates were also observed in relapsed/refractory marginal zone lymphoma. Safety profiles were manageable, with cytokine release syndrome being the most common adverse event.
Odronextamab ASH Presentations Underscore Impressive Outcomes in Lymphoma Trials
Odronextamab monotherapy showed complete responses in all evaluable patients with untreated follicular lymphoma in the OLYMPIA-1 trial. ELM-1 trial data revealed 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.
Odronextamab ASH Presentations Underscore Impressive Outcomes
Odronextamab monotherapy showed complete responses in all evaluable patients with untreated follicular lymphoma in the OLYMPIA-1 trial. ELM-1 trial data revealed durable responses in DLBCL post-CAR-T therapy, and ELM-2 demonstrated high complete response rates in relapsed/refractory marginal zone lymphoma. Presented at ASH 2024.
Rutgers Cancer Institute and RWJBarnabas Health to Unveil Pioneering Blood Cancer Research
Oral and poster presentations on various studies in hematology, including outcomes with bispecific T-cell engagers, phase 1 results of menin-MLL inhibitors, and real-world outcomes of CAR T-cell therapy, among others, scheduled for December 7-9, 2024.
Regeneron to Highlight Pioneering Pipeline Progress Across Multiple Modalities Spanning 10 Types of Blood Cancers and Disorders at ASH
Regeneron Pharmaceuticals announced new data from its hematology pipeline at the ASH 2024 Annual Meeting, showcasing advancements in treating blood cancers and disorders. Key highlights include head-to-head results for pozelimab plus cemdisiran vs. ravulizumab in PNH, odronextamab's potential in follicular lymphoma, and progress in DLBCL and MZL treatments.
Regeneron Reports Third Quarter 2024 Financial and Operating Results
Q3 2024 revenues up 11% to $3.72 billion; Dupixent global net sales by Sanofi up 23% to $3.82 billion; U.S. net sales for EYLEA HD and EYLEA up 3% to $1.54 billion; Libtayo global net sales up 24% to $289 million; GAAP diluted EPS up 30% to $11.54; FDA approves Dupixent for COPD and eosinophilic phenotype; positive results for Dupixent in CSU and BP trials.
Using novel BiTEs – Bispecific T-cell Engagers for the treatment of
B-NHL is a complex group of malignancies with distinct subtypes, including DLBCL and FL, each requiring specific management. BiTEs like glofitamab, epcoritamab, mosunetuzumab, and odronextamab offer novel treatment options for R/R B-NHL, each with unique characteristics influencing their selection based on factors such as treatment duration, cost, administration route, and patient considerations.
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Drug Development Updates
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