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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:
21h
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
P2, N=396, Recruiting, SWOG Cancer Research Network | Trial completion date: Dec 2029 --> Jun 2030 | Trial primary completion date: Dec 2025 --> Jun 2030
Trial completion date • Trial primary completion date
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cyclophosphamide • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • fludarabine IV • Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb)
18d
T-cell engaging antibodies for B-cell lymphomas. (PubMed, Semin Hematol)
This review focused on 4 CD20 × CD3 BsAbs, as well as surovatamig, a CD19 × CD3 BsAb currently under investigation that has demonstrated promising efficacy against relapsed/refractory B-cell lymphomas. All 4 CD20 × CD3 BsAbs are approved as third-line and beyond therapies: mosunetuzumab for follicular lymphoma (FL), glofitamab for diffuse large B-cell lymphoma (DLBCL), and epcoritamab and odronextamab for both FL and DLBCL (the latter in European Union only)...Multiple studies are currently evaluating these agents in both the relapsed/refractory and frontline settings, either as monotherapy or in combination with other agents. This review summarizes the efficacy and safety of each agent across B-cell lymphoma subtypes, along with their dosing schedules and CRS mitigation strategies.
Journal
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CD20 (Membrane Spanning 4-Domains A1)
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Epkinly (epcoritamab-bysp) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm) • Ordspono (odronextamab) • surovatamig (AZD0486)
1m
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, Suspended, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> Jun 2027 | Recruiting --> Suspended | Trial primary completion date: Jun 2026 --> Jun 2027
Trial completion date • Trial suspension • Trial primary completion date
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lenalidomide • Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb)
1m
BrUOG 401: Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma (clinicaltrials.gov)
P2, N=52, Recruiting, Brown University | Trial primary completion date: Aug 2025 --> Aug 2027
Trial primary completion date
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CD20 (Membrane Spanning 4-Domains A1)
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lenalidomide • Lunsumio (mosunetuzumab-axgb)
1m
Development and biomarkers of CD20/CD3 bispecific antibodies in diffuse large B-cell lymphoma. (PubMed, J Clin Exp Hematop)
BsAbs targeting CD20/CD3, such as epcoritamab, glofitamab, mosunetuzumab, and odronextamab, are rapidly progressing toward widespread clinical application. Although monotherapy remains the standard approach, clinical trials are exploring earlier-line use and combination strategies to further enhance outcomes. Particular attention is given to predictive biomarkers of response and mechanisms of resistance, including target antigen loss, tumor histology, prior therapies, intratumoral and peripheral T-cell status, and the emerging role of minimal residual disease monitoring.
Review • Journal
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CD20 (Membrane Spanning 4-Domains A1)
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Epkinly (epcoritamab-bysp) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm) • Ordspono (odronextamab)
2ms
Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma (clinicaltrials.gov)
P2, N=34, Active, not recruiting, Washington University School of Medicine | Trial completion date: May 2031 --> Apr 2029 | Trial primary completion date: May 2026 --> Sep 2025
Trial completion date • Trial primary completion date
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Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb)
2ms
Immune Effector Cell-Associated HLH-Like Syndrome (IEC-HS) in CAR-T and TCE-Treated Myeloma and B-Cell Malignancies: Insights from a Pharmacovigilance Study. (PubMed, Transplant Cell Ther)
IEC-HS is a rare but potentially fatal complication. Our disproportionality analysis identifies significant reporting signals for tisa-cel and cilta-cel. The high absolute number of cases observed for products like axi-cel appears to reflect high utilization rather than a disproportionate risk, underscoring the necessity of using statistical signal detection methods when interpreting spontaneous reports.
Journal • Adverse events
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ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • Epkinly (epcoritamab-bysp) • Elrexfio (elranatamab-bcmm) • Tecartus (brexucabtagene autoleucel) • Abecma (idecabtagene vicleucel) • Carvykti (ciltacabtagene autoleucel) • Lunsumio (mosunetuzumab-axgb) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv) • Columvi (glofitamab-gxbm)
2ms
Bispecific antibody combination regimens for B-cell non-Hodgkin's lymphomas. (PubMed, Expert Opin Biol Ther)
BsAbs such as epcoritamab, glofitamab, and mosunetuzumab have demonstrated substantial efficacy across both aggressive and indolent B-cell non-Hodgkin lymphomas (B-NHL), with largely manageable safety profiles...Approaches incorporating BsAbs into cytotoxic backbones and antibody-drug conjugates, as well as chemotherapy-free regimens such as BsAbs combined with lenalidomide, are discussed...BsAbs represent a major advance in B-NHL, offering high rates of deep remission with predictable safety and outpatient feasibility. As trial data continues to mature, BsAb-based regimens are poised to become foundational across multiple lines of therapy, reshaping expectations for patients with both aggressive and indolent lymphomas.
Review • Journal
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CD20 (Membrane Spanning 4-Domains A1)
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lenalidomide • Epkinly (epcoritamab-bysp) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm)
3ms
Trial primary completion date
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CD20 (Membrane Spanning 4-Domains A1) • CD4 (CD4 Molecule)
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lenalidomide • Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb)
3ms
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
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CD20 (Membrane Spanning 4-Domains A1)
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Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb) • iberdomide (CC-220) • Columvi (glofitamab-gxbm) • golcadomide (CC-99282)
3ms
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
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CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • CD79B (CD79b Molecule) • CD4 (CD4 Molecule)
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Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb)
3ms
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
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Brukinsa (zanubrutinib) • Lunsumio (mosunetuzumab-axgb)