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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:
4d
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)
5d
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)
8d
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)
2ms
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)
2ms
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)
2ms
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)
2ms
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)
2ms
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
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Lunsumio (mosunetuzumab-axgb)
2ms
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
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CD20 (Membrane Spanning 4-Domains A1)
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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
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CD20 (Membrane Spanning 4-Domains A1) • TNFRSF8 (TNF Receptor Superfamily Member 8) • BTK (Bruton Tyrosine Kinase) • CCR4 (C-C Motif Chemokine Receptor 4)
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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
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CD20 (Membrane Spanning 4-Domains A1)
|
CD20 positive
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Zynlonta (loncastuximab tesirine-lpyl) • Lunsumio (mosunetuzumab-axgb)