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    DRUG:

    Lunsumio (mosunetuzumab-axgb)

    i
    Other names: RG7828, BTCT4465A, RG 7828, BTCT 4465A, RO7030816, CD20-TBD, BTCT-4465A, RG-7828, RO 7030816, RO-7030816
    Company:
    Biogen, Roche
    Drug class:
    CD20 inhibitor, CD3 agonist
    Related drugs:
    1m
    CO41942: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma (clinicaltrials.gov)
    P1/2, N=237, Recruiting, Hoffmann-La Roche | Trial primary completion date: Oct 2028 --> Oct 2030
    Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD4 (CD4 Molecule)
    |
    lenalidomide • Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb)
    1m
    CO43805: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=121, Recruiting, Hoffmann-La Roche | Trial completion date: Mar 2029 --> Sep 2029 | Trial primary completion date: Mar 2027 --> Sep 2029
    Trial completion date • Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb) • iberdomide (CC-220) • Columvi (glofitamab-gxbm) • golcadomide (CC-99282)
    1m
    Polatuzumab Vedotin Induced CD20 Upregulation Contributes to the Efficacy of Mosunetuzumab in Combination With Polatuzumab Vedotin in Diffuse Large B-Cell Lymphoma Preclinical Models. (PubMed, EJHaem)
    These findings suggest that polatuzumab vedotin-induced CD20 upregulation provides a molecular rationale to explain the synergistic effect of this combination therapy. The authors have confirmed clinical trial registration is not needed for this submission.
    Preclinical • Journal
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • CD79B (CD79b Molecule) • CD4 (CD4 Molecule)
    |
    Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb)
    1m
    A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma (clinicaltrials.gov)
    P2, N=152, Recruiting, Memorial Sloan Kettering Cancer Center | N=76 --> 152
    Enrollment change
    |
    Brukinsa (zanubrutinib) • Lunsumio (mosunetuzumab-axgb)
    1m
    Mosunetuzumab in Combination With Platinum-Based Salvage Chemotherapy in Patients With Relapsed/Refractory Aggressive B Cell Lymphoma (clinicaltrials.gov)
    P1, N=24, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting | Trial completion date: May 2030 --> Oct 2029 | Trial primary completion date: May 2026 --> Jan 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Lunsumio (mosunetuzumab-axgb)
    2ms
    GOLD: A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHP (clinicaltrials.gov)
    P2, N=40, Recruiting, Danielle Wallace | Not yet recruiting --> Recruiting
    Enrollment open • Circulating tumor DNA
    |
    clonoSEQ
    |
    Lunsumio (mosunetuzumab-axgb)
    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
    Targeted therapies and resistance mechanisms in lymphoma: Current landscape and emerging solutions. (PubMed, Oncoscience)
    We comprehensively evaluate FDA-approved targeted agents, including monoclonal antibodies (rituximab, brentuximab vedotin, obinutuzumab, mogamulizumab), immune checkpoint inhibitors (nivolumab, pembrolizumab), CAR T-cell therapies (axi-cel, tisa-cel, liso-cel, brexu-cel), bispecific T-cell engagers (mosunetuzumab, epcoritamab), and small-molecule inhibitors (ibrutinib, idelalisib, venetoclax). In conclusion, understanding the molecular basis of lymphoma and resistance mechanisms is critical to optimizing targeted therapy. This review synthesizes current evidence to inform clinical decision-making and outlines future directions for durable, personalized lymphoma care.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD20 (Membrane Spanning 4-Domains A1) • TNFRSF8 (TNF Receptor Superfamily Member 8) • BTK (Bruton Tyrosine Kinase) • CCR4 (C-C Motif Chemokine Receptor 4)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • Gazyva (obinutuzumab) • Adcetris (brentuximab vedotin) • Zydelig (idelalisib) • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • Epkinly (epcoritamab-bysp) • Poteligeo (mogamulizumab-kpkc) • Lunsumio (mosunetuzumab-axgb)
    2ms
    Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
    P2, N=36, Recruiting, City of Hope Medical Center | Trial completion date: Aug 2025 --> Apr 2026 | Trial primary completion date: Aug 2025 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive
    |
    Zynlonta (loncastuximab tesirine-lpyl) • Lunsumio (mosunetuzumab-axgb)
    2ms
    A Phase 2, Multicenter, Open-Label Trial to Evaluate Efficacy and Safety of Subcutaneous (SC) Mosunetuzumab in Previously Untreated Low Tumor Burden Follicular Lymphoma (LTB-FL). (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Tel-Aviv Sourasky Medical Center
    New P2 trial
    |
    Lunsumio (mosunetuzumab-axgb)
    3ms
    LOTIS 7: A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7) (clinicaltrials.gov)
    P1, N=200, Recruiting, ADC Therapeutics S.A. | Trial completion date: Dec 2026 --> Oct 2027 | Trial primary completion date: Dec 2025 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    Gazyva (obinutuzumab) • Zynlonta (loncastuximab tesirine-lpyl) • Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm)
    3ms
    A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL (clinicaltrials.gov)
    P2, N=36, Recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Aug 2025 --> Aug 2027
    Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    lenalidomide • Monjuvi (tafasitamab-cxix) • Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb)