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    DRUG:

    Lunsumio (mosunetuzumab-axgb)

    i
    Other names: RG-7828, RO 7030816, RO-7030816, RG7828, BTCT4465A, RG 7828, BTCT 4465A, RO7030816, CD20-TBD, BTCT-4465A
    Company:
    Biogen, Roche
    Drug class:
    CD20 inhibitor, CD3 agonist
    Related drugs:
    5d
    Phase 2 Study Of Mosunetuzumab In Patients With Chronic Lymphocytic Leukemia With Positive MRD (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    TP53 (Tumor protein P53) • IGH (Immunoglobulin Heavy Locus) • CD4 (CD4 Molecule)
    |
    TP53 mutation
    |
    clonoSEQ
    |
    Lunsumio (mosunetuzumab-axgb)
    12d
    CUREFL03: Mosunetuzumab and Zeprumetostat in Treating Patients With Follicular Lymphoma (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China
    New P2 trial
    |
    CD20 positive
    |
    zeprumetostat (SHR-2554) • Lunsumio (mosunetuzumab-axgb)
    14d
    CaDAnCe-104: A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies (clinicaltrials.gov)
    P1/2, N=80, Recruiting, BeOne Medicines
    New P1/2 trial
    |
    Gazyva (obinutuzumab) • Brukinsa (zanubrutinib) • Lunsumio (mosunetuzumab-axgb) • sonrotoclax (BGB-11417) • Columvi (glofitamab-gxbm) • catadegbrutinib (BGB-16673)
    16d
    Mosunetuzumab With Chemotherapy for the Treatment of Patients With Untreated C-Myc Rearrangement Positive High Grade B Cell Lymphoma or Diffuse Large B Cell Lymphoma (clinicaltrials.gov)
    P1/2, N=30, Recruiting, OHSU Knight Cancer Institute | Trial primary completion date: Apr 2026 --> Dec 2026
    Trial primary completion date
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • Lunsumio (mosunetuzumab-axgb)
    17d
    Mosunetuzumab in Combination With Pirtobrutinib in Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia (MPOWER) (clinicaltrials.gov)
    P2, N=25, Not yet recruiting, University of Utah
    New P2 trial
    |
    Jaypirca (pirtobrutinib) • Lunsumio (mosunetuzumab-axgb)
    19d
    Mosunetuzumab plus polatuzumab vedotin in relapsed/refractory MCL after BTK inhibitor therapy: a phase 2 study. (PubMed, Blood)
    This is the first bispecific-ADC combination therapy study in MCL. (Funded by F. Hoffmann-La Roche Ltd; ClinicalTrials.gov, NCT03671018).
    P2 data • Journal
    |
    TP53 (Tumor protein P53) • CD79B (CD79b Molecule)
    |
    Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb)
    24d
    Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
    P1, N=30, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting
    Enrollment open
    |
    lenalidomide • Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb)
    1m
    Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma (clinicaltrials.gov)
    P2, N=23, Active, not recruiting, Weill Medical College of Cornell University | Recruiting --> Active, not recruiting | N=50 --> 23
    Enrollment closed • Enrollment change
    |
    EZH2 mutation
    |
    Tazverik (tazemetostat) • Lunsumio (mosunetuzumab-axgb)
    2ms
    UPCC 48420: CAR-T Followed by Bispecific Antibodies (clinicaltrials.gov)
    P2, N=42, Recruiting, Abramson Cancer Center at Penn Medicine | Trial completion date: Jun 2027 --> Dec 2028 | Trial primary completion date: Jun 2026 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    Gazyva (obinutuzumab) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm)
    2ms
    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)
    3ms
    GA45799: A Study to understand the Effectiveness, Safety, and what the body does to Mosunetuzumab in participants with Systemic Lupus Erythematosus with or without Active Lupus Nephritis (2024-519930-22-00)
    P1/2, N=5, Not yet recruiting, F. Hoffmann-La Roche AG
    New P1/2 trial
    |
    Lunsumio (mosunetuzumab-axgb)
    3ms
    BGB-16673-104: A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies (2024-516234-35-00)
    P1/2, N=99, Recruiting, BeOne Medicines AG
    New P1/2 trial
    |
    Gazyva (obinutuzumab) • Brukinsa (zanubrutinib) • Lunsumio (mosunetuzumab-axgb) • sonrotoclax (BGB-11417) • Columvi (glofitamab-gxbm) • catadegbrutinib (BGB-16673)