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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:
    2d
    Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis (clinicaltrials.gov)
    P1, N=90, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Jul 2028 --> Sep 2029 | Trial primary completion date: Jul 2028 --> Sep 2029
    Trial completion date • Trial primary completion date
    |
    Ordspono (odronextamab) • vonsetamig (REGN5459)
    8d
    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, Completed, Regeneron Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion
    |
    Libtayo (cemiplimab-rwlc) • Ordspono (odronextamab)
    26d
    OLYMPIA-3: A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
    P3, N=904, Recruiting, Regeneron Pharmaceuticals | Active, not recruiting --> Recruiting
    Enrollment open
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Ordspono (odronextamab)
    30d
    OLYMPIA-4: 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 (clinicaltrials.gov)
    P3, N=216, Active, not recruiting, Regeneron Pharmaceuticals | Trial completion date: May 2027 --> May 2029 | Trial primary completion date: May 2027 --> May 2028 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    cisplatin • carboplatin • gemcitabine • Rituxan (rituximab) • cytarabine • ifosfamide • etoposide IV • Ordspono (odronextamab)
    1m
    ATHENA-1: A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas (clinicaltrials.gov)
    P1, N=107, Recruiting, Regeneron Pharmaceuticals | Trial completion date: May 2029 --> Jan 2030 | Trial primary completion date: Jun 2027 --> Feb 2029
    Trial completion date • Trial primary completion date
    |
    Ordspono (odronextamab) • REGN5837
    2ms
    Dynamics of complete responses (CRs) in patients with relapsed or refractory follicular lymphoma (R/R FL) treated with odronextamab in the ELM-2 study. (PubMed, Hemasphere)
    Treatment-emergent adverse events (TEAEs) led to treatment discontinuation in 16.0% of patients with CR; the most common TEAE was cytokine release syndrome (56.4%). This generally manageable safety profile and the sustainability of CRs support odronextamab as a potential long-term treatment for heavily pretreated R/R FL.
    Journal
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Ordspono (odronextamab)
    3ms
    Odronextamab in Low Tumor Volume Advanced FL (clinicaltrials.gov)
    P2, N=35, Recruiting, Gottfried von Keudell, MD PhD | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Ordspono (odronextamab)
    3ms
    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 Previously Untreated Follicular Lymphoma (clinicaltrials.gov)
    P3, N=822, Recruiting, Regeneron Pharmaceuticals | N=462 --> 822 | Trial completion date: Nov 2031 --> Nov 2029 | Active, not recruiting --> Recruiting
    Enrollment open • Enrollment change • Trial completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • bendamustine • Ordspono (odronextamab)
    3ms
    Bispecific Antibodies in B-Cell Lymphomas: Mechanisms, Efficacy, Toxicity, and Management. (PubMed, Medicina (Kaunas))
    This review examines CD20 × CD3 bispecific antibodies (BsAbs) like mosunetuzumab, epcoritamab, odronextamab, and glofitamab, which link malignant B-cells and T-cells, thus inducing targeted tumor lysis...This review details their mechanisms, grading, and management, including the use of tocilizumab and corticosteroids...Expert recommendations for antimicrobial prophylaxis, including herpes and varicella zoster virus, pneumocystis, and immunoglobulin supplements are crucial for mitigating these risks. While BsAbs offer an "off-the-shelf" advantage, balancing their efficacy with comprehensive toxicity management is crucial for maximizing patient outcomes.
    Review • Journal
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Epkinly (epcoritamab-bysp) • Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm) • Ordspono (odronextamab)
    4ms
    Comparative effectiveness of odronextamab monotherapy versus real-world systemic therapies in R/R follicular lymphoma. (PubMed, Leuk Lymphoma)
    After weighting, objective response rate (80.5 vs. 52.7%; odds ratio [OR], 3.75 [95% CI, 1.98-7.11]), complete response rate (73.4 vs. 33.6%; OR, 5.39 [95% CI, 2.76-10.53]), median (months) progression-free survival (20.7 vs. 11.5; hazard ratio [HR], 0.76 [95% CI, 0.46-1.24]), event-free survival (19.5 vs. 7.6; HR, 0.52 [95% CI, 0.36-0.77]), overall survival (not reached vs. 26.2; HR, 0.60 [95% CI, 0.37-0.97]), and time to next treatment or death (40.4 vs. 9.7; HR, 0.49 [95% CI, 0.33-0.72]) favored odronextamab versus 3L + RWST. Despite FLORA's limited sample size, these data further support odronextamab monotherapy for 3L + R/R FL.
    Journal • HEOR • Real-world evidence
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Ordspono (odronextamab)
    4ms
    OLYMPIA-3: A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
    P3, N=904, Active, not recruiting, Regeneron Pharmaceuticals | Trial completion date: Apr 2029 --> Sep 2029
    Trial completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • 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 | Trial completion date: Dec 2025 --> May 2026 | Trial primary completion date: Dec 2025 --> May 2026
    Trial completion date • Trial primary completion date
    |
    Libtayo (cemiplimab-rwlc) • Ordspono (odronextamab)