LUNSUMIO

(Mosunetuzumab)

Phase 3Monoclonal antibody

LUNSUMIO is a monoclonal antibody that works as a B-Lymphocyte Antigen CD20 Binding Agent; T Cell Surface Glycoprotein CD3 Binding Agent.[2] It is being investigated across 20 indications, with its most advanced program in Phase 3.[1]

LUNSUMIO is one of 266 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Phase 3.

Indications

Total Trials

Active Trials

265

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Systemic Lupus ErythematosusActive, not recruiting

Non-Hodgkins LymphomaActive, not recruiting

LymphomaActive, not recruiting

LeukemiaNot yet recruiting

Richter SyndromeActive, not recruiting

Diffuse Large B-Cell LymphomaActive, not recruiting

Chronic Lymphocytic LeukemiaActive, not recruiting

LupusRecruiting

Recurrent Diffuse Large B-Cell LymphomaSuspended

B-Cell MalignancyRecruiting

Systemic Lupus ErythematosusPhase 1

Active, not recruiting

Non-Hodgkins LymphomaPhase 3

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

LeukemiaPhase 2

Not yet recruiting

Richter SyndromePhase 2

Active, not recruiting

Diffuse Large B-Cell LymphomaPhase 2

Active, not recruiting

Chronic Lymphocytic LeukemiaPhase 1

Active, not recruiting

LupusPhase 2

Recruiting

Recurrent Diffuse Large B-Cell LymphomaPhase 2

Suspended

B-Cell MalignancyPreclinical

Recruiting

Showing 10 of 20 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

LUNSUMIO

Roche

Phase 3

14 2

Oncaspar

SServier

Preclinical

15 3

Zofran

Novartis

Preclinical

2 4

Tafasitamab

Incyte

Preclinical

7 5

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 6

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 7

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

PEG-Intron

1 9

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—10

Rhg-CSF

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Nodular Lymphocyte Predominant B-Cell Lymphoma

NCT05886036

Phase 2Recruiting

Follicular Lymphoma

NCT05389293

Recruiting

Follicular Lymphoma

NCT07278921

Q1 2027

Phase 2Recruiting

Lymphoma

NCT06442475

Phase 3Active, not recruiting

Lymphoma

NCT05171647

Phase 2Recruiting

Recurrent Diffuse Large B-Cell Lymphoma

NCT05672251

Clinical

Trials by Indication[1]

Lymphoma14 trials

Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma

Recruiting·—·Phase 2·NCT04792502·52 enrolled

Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma

Recruiting·UUniversity of Washington·Phase 2·NCT06442475·20 enrolled

A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma

Completed· Roche logo

Roche·Phase 1/2·NCT03677141·117 enrolled

Show 11 more trials

Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma

Completed·UUniversity of Washington·Phase 2·NCT05169658·42 enrolled

Mosunetuzumab in Combination With Platinum-Based Salvage Chemotherapy in Patients With Relapsed/Refractory Aggressive B Cell Lymphoma

Active, not recruiting·WWashington University School of Medicine·Phase 1·NCT05464329·24 enrolled

Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma

Recruiting·—·Phase 2·NCT06569680·35 enrolled

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)

Recruiting·AADC Therapeutics S.A.·Phase 1·NCT04970901·200 enrolled

CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma (NHL).

Recruiting·LLazaros Lekakis·Phase 2·NCT05260957·22 enrolled

Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma

Recruiting·TThe Lymphoma Academic Research Organisation·Phase 3·NCT06006117·260 enrolled

An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Participants With B-Cell Non-Hodgkin Lymphoma

Terminated· Roche logo

Roche·Phase 1/2·NCT05315713·8 enrolled

A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06563505·36 enrolled

Mosunetuzumab Consolidation Therapy After autoSCT in r/r Aggressive B Cell Lymphoma

Recruiting·WWashington University School of Medicine·Phase 1·NCT05412290·15 enrolled

A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Active, not recruiting· Roche logo

Roche·Phase 3·NCT05171647·208 enrolled

A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma

Active, not recruiting· Roche logo

Roche·Phase 1/2·NCT03671018·422 enrolled

Follicular Lymphoma9 trials

Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma

Recruiting·WWeill Medical College of Cornell University·Phase 2·NCT05994235·50 enrolled

Mosunetuzumab and Polatuzumab Vedotin for the Treatment of Patients With Relapsed or Refractory Grade 1-3a Follicular Lymphoma

Recruiting·—·Phase 2·NCT06453044·41 enrolled

Pirtobrutinib and Mosunetuzumab for the Treatment of Relapsed/Refractory Grades 1-3A Follicular Lymphoma, PROMOTE-FL Trial

Recruiting·UUniversity of Washington·Phase 2·NCT06948786·22 enrolled

Show 6 more trials

Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries

Recruiting·OOslo University Hospital·Phase 2·NCT05849857·80 enrolled

Study to Evaluate the Response to Treatment With Mosunetuzumab in Relapsed/Refractory Follicular Lymphoma (FL) After at Least Two Lines of Therapy, Within the Compassionate Use Program (CUP).

Recruiting·AAndrés José Maria Ferreri··NCT07278921·25 enrolled

Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5

Recruiting·TThe Lymphoma Academic Research Organisation·Phase 3·NCT06284122·790 enrolled

A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05389293·152 enrolled

Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma

Active, not recruiting·WWashington University School of Medicine·Phase 2·NCT05410418·34 enrolled

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

Active, not recruiting· Roche logo

Roche·Phase 1/2·NCT04246086·237 enrolled

Diffuse Large B-Cell Lymphoma6 trials

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

Recruiting·DDanielle Wallace·Phase 2·NCT06828991·40 enrolled

Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Recruiting·SSWOG Cancer Research Network·Phase 2·NCT05633615·396 enrolled

A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma

Completed· Roche logo

Roche·Phase 1·NCT04313608·23 enrolled

Show 3 more trials

Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma

Not yet recruiting·MMedical College of Wisconsin·Phase 2·NCT06594939·31 enrolled

Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Participants With Previously Untreated Diffuse Large B-Cell Lymphoma

Completed· Roche logo

Roche·Phase 1/2·NCT03677154·188 enrolled

A Phase Ib/II Study Evaluating the Safety and Efficacy of DA EPOCH in Combination With Mosuntuzumab (EPICSUN) in Previously Untreated C-Myc Rearrangement Positive High-Grade B Cell Lymphomas Including Myc Rearranged Diffuse Large B Cell Lymphoma and High Grade B Cell Lymphoma

Recruiting·OOHSU Knight Cancer Institute·Preclinical·NCT06249191·40 enrolled

Blood Cancer1 trial

A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.

Withdrawn·EEpizyme, Inc.·Phase 1/2·NCT05205252

CAR-T1 trial

CAR-T Followed by Bispecific Antibodies

Recruiting·—·Phase 2·NCT04889716·42 enrolled

18 more indications

Lenalidomide1 trial

A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05615636·36 enrolled

Tislelizumab1 trial

A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for r/r FL

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT07031700·22 enrolled

B-cell acute lymphoblastic leukemia1 trial

A Phase I Study of Mosunetuzumab for Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT05961696

Systemic Lupus Erythematosus1 trial

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus

Completed· Roche logo

Roche·Phase 1·NCT05155345·15 enrolled

Phase II1 trial

CHOP Plus Mosunetuzumab as First Line in Patients With Richter´s Syndrome: a Phase II Study of the Spanish Group of CLL

Recruiting·GGELLC (Grupo Español de Leucemia Linfocítica Crónica)·Phase 2·NCT06926205·34 enrolled

MRD1 trial

Mosunetuzumab for CLL MRD Clearance

Recruiting·IInhye Ahn·Phase 1/2·NCT07052695·40 enrolled

B-cell Malignancies1 trial

A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies

Active, not recruiting· Roche logo

Roche·Phase 2·NCT05207670·320 enrolled

Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue1 trial

MOZART MZL: A Randomized Phase II Study Evaluating Mosunetuzumab Alone and in Combination With Either Zanubrutinib or Polatuzumab Vedotin for the Treatment of Patients With Relapsed/Refractory Marginal Zone Lymphoma

Not yet recruiting·SSWOG Cancer Research Network·Phase 2·NCT07638722·138 enrolled

Classic Follicular Lymphoma1 trial

Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma

Recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT06337318·600 enrolled

B-cell Malignancy1 trial

A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies

Recruiting·BBeOne Medicines·Preclinical·NCT06634589·80 enrolled

Recurrent Diffuse Large B-Cell Lymphoma1 trial

A Phase 2 Study of Loncastuximab Tesirine Plus Mosunetuzumab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Recruiting·CCity of Hope Medical Center·Phase 2·NCT05672251·36 enrolled

Relapsed or Refractory Follicular Lymphoma1 trial

Phase III Randomized, Open-Label, Multicenter Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a Non-Randomized Single Arm US Extension of Mosunetuzumab in Combination With Lenalidomide in Patients With Follicular Lymphoma After at Least One Line of Systemic Therapy

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04712097·478 enrolled

Nodular Lymphocyte Predominant B-Cell Lymphoma1 trial

NORM: Nodular Lymphocyte-Predominant Hodgkin Lymphoma Patients Treated in a Randomized Phase 2 Trial With Either Rituximab or Mosunetuzumab

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05886036·70 enrolled

Diffuse Large B-Cell Lymphoma, Not Otherwise Specified1 trial

A Phase 1 Study of Mosunetuzumab With Polatuzumab Vedotin and Lenalidomide (M+Pola+Len) in Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT06015880·30 enrolled

Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma1 trial

A Phase IB Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Recruiting· Roche logo

Roche·Phase 1·NCT05091424·332 enrolled

Leukemia1 trial

A Phase 2 Study Of Mosunetuzumab In Patients With Chronic Lymphocytic Leukemia With Positive Measurable Residual Disease

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07566364·30 enrolled

Lupus1 trial

A Phase II Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Mosunetuzumab in Patients With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis

Recruiting· Roche logo

Roche·Phase 2·NCT07598396·30 enrolled

Relapsed/Refractory Non-Hodgkin Lymphoma1 trial

A Phase 1/2, Multi-Center, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BMS-986458, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed/Refractory Non-Hodgkin Lymphomas (R/R NHL)

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Preclinical·NCT06090539·460 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 22, 2022

LUNSUMIO

BLA BLA761263

Sources

References

[1]
ClinicalTrials.gov — 49 trial records for Mosunetuzumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Mosunetuzumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Mosunetuzumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761263). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: B-Lymphocyte Antigen CD20 Binding Agent; T Cell Surface Glycoprotein CD3 Binding Agent[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Roche

LUNSUMIO

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Lymphoma14 trials

Follicular Lymphoma9 trials

Diffuse Large B-Cell Lymphoma6 trials

Blood Cancer1 trial

CAR-T1 trial

Lenalidomide1 trial

Tislelizumab1 trial

B-cell acute lymphoblastic leukemia1 trial

Systemic Lupus Erythematosus1 trial

Phase II1 trial

MRD1 trial

B-cell Malignancies1 trial

Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue1 trial

Classic Follicular Lymphoma1 trial

B-cell Malignancy1 trial

Recurrent Diffuse Large B-Cell Lymphoma1 trial

Relapsed or Refractory Follicular Lymphoma1 trial

Nodular Lymphocyte Predominant B-Cell Lymphoma1 trial

Diffuse Large B-Cell Lymphoma, Not Otherwise Specified1 trial

Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma1 trial

Leukemia1 trial

Lupus1 trial

Relapsed/Refractory Non-Hodgkin Lymphoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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