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 227 small molecule programs targeting Hematopoietic and Lymphoid System Neoplasm. It is currently in Phase 3.

Indications

Total Trials

Active Trials

226

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Hematopoietic and Lymphoid System NeoplasmActive, not recruiting

Relapsed/refractory Non-Hodgkin LymphomaRecruiting

LymphomaActive, not recruiting

B-Cell Non Hodgkin LymphomaActive, not recruiting

LupusRecruiting

Phase IIRecruiting

Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedRecruiting

Nodular Lymphocyte Predominant B-Cell LymphomaRecruiting

Relapsed or Refractory Follicular LymphomaActive, not recruiting

B-Cell MalignancyRecruiting

Hematopoietic and Lymphoid System NeoplasmPreclinical

Active, not recruiting

Relapsed/refractory Non-Hodgkin LymphomaPreclinical

Recruiting

LymphomaPhase 2

Active, not recruiting

B-Cell Non Hodgkin LymphomaPhase 1

Active, not recruiting

LupusPhase 2

Recruiting

Phase IIPhase 2

Recruiting

Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedPhase 1

Recruiting

Nodular Lymphocyte Predominant B-Cell LymphomaPhase 2

Recruiting

Relapsed or Refractory Follicular LymphomaPhase 3

Active, not recruiting

B-Cell MalignancyPreclinical

Recruiting

Showing 10 of 20 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

LUNSUMIO

Roche

Phase 3

10 2

Zofran

Novartis

Preclinical

2 3

Cabenuva

GSK

Preclinical

1 4

Norvir

AbbVie

Preclinical

1 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

Nuvigil

NNuvo Research GmbH

Preclinical

1 8

Elitek

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

Preclinical

—9

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

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

Recruiting

Follicular Lymphoma

NCT07278921

Q1 2027

Phase 3Active, not recruiting

Non-Hodgkin Lymphoma

NCT05171647

Phase 2Recruiting

Recurrent Diffuse Large B-Cell Lymphoma

NCT05672251

Q2 2027

PreclinicalRecruiting

Diffuse Large B-Cell Lymphoma

NCT06249191

Phase 1Recruiting

Diffuse Large B-Cell Lymphoma, Not Otherwise Specified

NCT06015880

Clinical

Trials by Indication[1]

Lymphoma10 trials

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

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

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

Show 7 more trials

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 in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma

Recruiting·—·Phase 2·NCT06569680·35 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

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

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

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

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

Follicular Lymphoma10 trials

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

Recruiting·—·Phase 2·NCT06453044·41 enrolled

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

Show 7 more trials

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

Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma

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

Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma

Active, not recruiting·WWashington University School of Medicine·Phase 2·NCT05410418·34 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 Phase Ib/II, Open-Label, Multicenter Study With a Non-Randomized Stage Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab Plus Lenalidomide (+Len), and a Randomized Stage Evaluating the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Patients With Follicular Lymphoma

Active, not recruiting· Roche logo

Roche·Preclinical·NCT04246086·237 enrolled

BrUOG 401: A Phase 2 Study of Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma

Recruiting·BBrown University·Phase 2·NCT04792502·52 enrolled

An Open-Label, Multicenter, Single-Arm, Sequential Phase-2 Study of Mosunetuzumab Alone or With Zanubrutinib for the Treatment of Patients With Newly Diagnosed Follicular Lymphoma in Need of Systemic Therapy

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

Diffuse Large B-Cell Lymphoma5 trials

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

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

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

Show 2 more 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

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

Non-Hodgkin Lymphoma2 trials

An Open-Label, Multicenter, Phase II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Subcutaneous Mosunetuzumab Monotherapy in Patients With Select B-Cell Malignancies

Active, not recruiting· Roche logo

Roche·Phase 2·NCT05207670·320 enrolled

A Randomized, Open-Label, Multicenter Phase III Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin in Comparison With 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

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

21 more indications

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

Blood Cancer1 trial

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

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

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

MRD1 trial

Mosunetuzumab for CLL MRD Clearance

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

Hodgkin Lymphoma1 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

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

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

Large B-cell Lymphoma1 trial

Phase II Study of Dual Targeting of CD19 and CD20 Antigens Using Sequential CD19-directed CAR-T Cells Followed by Mosunetuzumab or Glofitamab in Relapsed or Refractory Diffuse Large B-cell or Transformed Follicular Lymphomas

Active, not recruiting·AAbramson Cancer Center at Penn Medicine·Phase 2·NCT04889716·23 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

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

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

Ann Arbor Stage II Follicular Lymphoma1 trial

Low Dose Mosunetuzumab for Indolent B-Cell Lymphoma

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

Diffuse Large B-cell Lymphoma(DLBCL)1 trial

Multicenter Phase II Study of Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma

Recruiting·MMedical College of Wisconsin·Phase 2·NCT06594939·31 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

Leukemia1 trial

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

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07566364·30 enrolled

B-cell Non Hodgkin Lymphoma1 trial

A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

Active, not recruiting·AADC Therapeutics S.A.·Phase 1·NCT04970901·154 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

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

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

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

Q2 2027

Trials by Indication[1]

Lymphoma10 trials

Follicular Lymphoma10 trials

Diffuse Large B-Cell Lymphoma5 trials

Non-Hodgkin Lymphoma2 trials

Systemic Lupus Erythematosus1 trial

Phase II1 trial

Blood Cancer1 trial

Tislelizumab1 trial

MRD1 trial

B-cell acute lymphoblastic leukemia1 trial

Hodgkin Lymphoma1 trial

Classic Follicular Lymphoma1 trial

Relapsed/Refractory Non-Hodgkin Lymphoma1 trial

Large B-cell Lymphoma1 trial

B-cell Malignancy1 trial

Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma1 trial

Nodular Lymphocyte Predominant B-Cell Lymphoma1 trial

Ann Arbor Stage II Follicular Lymphoma1 trial

Diffuse Large B-cell Lymphoma(DLBCL)1 trial

Lupus1 trial

Leukemia1 trial

B-cell Non Hodgkin Lymphoma1 trial

Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue1 trial

Recurrent Diffuse Large B-Cell Lymphoma1 trial

Relapsed or Refractory Follicular Lymphoma1 trial

Diffuse Large B-Cell Lymphoma, Not Otherwise Specified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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