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    DRUG:

    Ordspono (odronextamab)

    i
    Other names: REGN1979, REGN 1979, RGN1979, REGN-1979
    Company:
    Regeneron, ZAI Lab
    Drug class:
    CD20 inhibitor, CD3 agonist
    Related drugs:
    2ms
    ELM-2: A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies (clinicaltrials.gov)
    P2, N=515, Active, not recruiting, Regeneron Pharmaceuticals | Trial completion date: Dec 2029 --> Dec 2028 | Trial primary completion date: Aug 2028 --> Jul 2026 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Ordspono (odronextamab)
    2ms
    Bispecific Monoclonal Antibodies in Diffuse Large B-Cell Lymphoma: Dawn of a New Era in Targeted Therapy. (PubMed, Cancers (Basel))
    Currently, approximately sixty percent of patients are cured with R-CHOP as frontline treatment, while the remaining patients experience primary refractory or relapsed (R/R) disease. Recently, the introduction of Pola-R-CHP as front-line therapy has represented a major advance in the management of DLBCL, resulting in improved outcomes...The most extensively studied BsAbs, in both the frontline and relapsed/refractory (R/R) settings, include epcoritamab, glofitamab, mosunetuzumab, and odronextamab...EMA has also approved glofitamab in combination with gemcitabine and oxaliplatin (GemOx) for patients with R/R DLBCL ineligible for ASCT, whereas this indication has not been approved by FDA...BsAbs represent a breakthrough therapy in the treatment of DLBCL, especially in R/R diseases. The purpose of this article is to review the landscape of BsAbs in DLBCL.
    Review • Journal
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    gemcitabine • Rituxan (rituximab) • oxaliplatin • Epkinly (epcoritamab-bysp) • Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm) • Ordspono (odronextamab)
    2ms
    Dose Escalation Study With Bispecific Antibodies in Adult Patients With Lupus Nephritis (clinicaltrials.gov)
    P1, N=126, Not yet recruiting, Regeneron Pharmaceuticals | N=72 --> 126
    Enrollment change
    |
    Ordspono (odronextamab) • vonsetamig (REGN5459)
    2ms
    MODELING DRUG-ORGAN INTERACTIONS AND OPTIMIZING IMMUNOTHERAPY: A QUANTITATIVE SYSTEMS PHARMACOLOGY AND ODRONEXTAMAB DYNAMICS. (PubMed, Georgian Med News)
    This study provides mechanistic insights into how cardiorenal medications improve systemic function via sugar, water, and salt modulation. Additionally, it presents a validated, optimized dosing strategy for odronextamab that reduces IL-6 levels and enhances safety in B-NHL patients. Integrating QSP with real-world data supports personalized pharmacotherapy and underscores the utility of computational modeling in drug development and clinical decision-making.
    Journal
    |
    IL6 (Interleukin 6)
    |
    Ordspono (odronextamab)
    2ms
    OLYMPIA-1: 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 Adult Participants With Follicular Lymphoma (clinicaltrials.gov)
    P3, N=462, Active, not recruiting, Regeneron Pharmaceuticals | Recruiting --> Active, not recruiting | Trial completion date: Apr 2029 --> Nov 2031 | Trial primary completion date: Apr 2029 --> Feb 2028
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • bendamustine • Ordspono (odronextamab)
    2ms
    ELM-1: Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies (clinicaltrials.gov)
    P1, N=200, Completed, Regeneron Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion
    |
    Ordspono (odronextamab)
    3ms
    OLYMPIA-2: 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 (clinicaltrials.gov)
    P3, N=733, Active, not recruiting, Regeneron Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Ordspono (odronextamab)
    3ms
    Odronextamab for Relapsed and Refractory Large B-cell Lymphomas Before CAR-T (clinicaltrials.gov)
    P2, N=27, Recruiting, University of Washington | Initiation date: Jul 2025 --> Oct 2025
    Trial initiation date
    |
    Ordspono (odronextamab)
    3ms
    CD20×CD3 bispecific antibody achieved significant efficacy in patients with large B-cell lymphoma relapsing after or refractory to CAR-T therapy: a systematic review and meta-analysis. (PubMed, Front Oncol)
    This study aimed to investigate the efficacy of CD20×CD3 BsAbs (mosunetuzumab, glofitamab, odronextamab, and epcoritamab) in patients with LBCL who experienced relapse or refractory disease following CAR-T therapy. To validate these findings and determine the optimal sequencing of BsAbs and CAR-T therapy for R/R LBCL patients, prolonged follow-up periods and further prospective clinical trials are warranted. https://www.crd.york.ac.uk/prospero/, identifier CRD42024621005.
    Retrospective data • Review • Journal
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Epkinly (epcoritamab-bysp) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm) • Ordspono (odronextamab)
    3ms
    Early clearance of circulating tumor DNA and association with odronextamab response in relapsed/refractory FL and DLBCL. (PubMed, Blood Adv)
    MRD by ctDNA may be prognostic of outcomes with odronextamab in FL/DLBCL and could form the basis of response-guided treatment paradigms. This trial is registered at www.ClinicalTrials.gov as NCT03888105.
    Journal • Circulating tumor DNA
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Ordspono (odronextamab)
    4ms
    Odronextamab for the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma Before and After Chimeric Antigen Receptor T-cell Therapy (clinicaltrials.gov)
    P2, N=34, Recruiting, University of California, Davis | Not yet recruiting --> Recruiting | Trial completion date: Jan 2029 --> Apr 2029 | Initiation date: Apr 2025 --> Aug 2025 | Trial primary completion date: Oct 2028 --> Feb 2029
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
    |
    Ordspono (odronextamab)
    4ms
    CLIO-1: A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies (clinicaltrials.gov)
    P1, N=105, Active, not recruiting, Regeneron Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Libtayo (cemiplimab-rwlc) • Ordspono (odronextamab)