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Mosunetuzumab (CD20 x CD3)

(RG7828)

HEMATOLOGY

Phase II

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

NCT03677141

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

NCT03671018

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

NCT03677154

Phase I

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

NCT03677141

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

NCT03671018

A Safety and Pharmacokinetic Study of BTCT4465A (Mosunetuzumab) as a Single Agent and Combined With Atezolizumab in Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

NCT02500407

A Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Therapy in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma Who Are Unable to Tolerate Full-Dose Chemotherapy

NCT03677154

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

NCT04313608

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide, Glofitamab + Lenalidomide, and Glofitamab + Lenalidomide + Obinutuzumab in Participants With Relapsed or Refractory Follicular Lymphoma

NCT04246086

This compound and its uses are investigational and have not been approved by the US Food and Drug Administration. Efficacy and safety have not been established. The information presented should not be construed as a recommendation for use. The relevance of findings in preclinical studies to humans is currently being evaluated.

Mosunetuzumab, a T-cell bispecific antibody

Mosunetuzumab is an investigational, humanized, T-cell bispecific antibody designed to engage T cells and redirect their cytotoxic activity against malignant B cells. Mosunetuzumab simultaneously binds to CD3 epsilon (CD3ε), a component of the T-cell receptor (TCR) complex, and to CD20, a B-cell surface protein expressed in a majority of B-cell malignancies. This results in crosslinking of the TCR, inducing downstream signaling events that lead to B-cell killing.1-3

Mosunetuzumab is equipped with structural features that promote T-cell recruitment and retention, resulting in an antitumor effect.1,4 In preclinical models, mosunetuzumab induced T-cell proliferation and B-cell death; furthermore, efficient B-cell killing was achieved at low effector-to-target (T cell:B cell) ratios.1 Use of mosunetuzumab in combination with PD-L1 inhibition may address adaptive immune resistance mechanisms to enhance anticancer activity against B-cell malignancies.4-6

1. Mosunetuzumab is an investigational, full-length, T-cell bispecific antibody designed to simultaneously bind to CD20 on the surface of malignant B cells and to CD3ε on cytotoxic T cells, resulting in crosslinking of the TCR and subsequent formation of an immunologic synapse and T-cell activation.1,2,7

Formation of an immunologic synapse and T-cell activation

2. T cells are activated through a cascade of downstream signaling events, leading to the secretion of cytotoxic granules and B-cell death. T-cell activation promotes the proliferation/expansion of pre-existing T cells, which may further contribute to the depletion of B cells.1,2,8

Activated T cells

3. In preclinical models, mosunetuzumab induced T-cell activation and proliferation, as well as B-cell death.1 Mosunetuzumab continues to be investigated in an ongoing clinical study, including in combination with PD-L1 inhibition for the treatment of B-cell malignancies.9

Mosunetuzumab induced T-cell activation and proliferation

Mosunetuzumab proposed MOA

Mosunetuzumab proposed MOA

Watch how mosunetuzumab directs T cells against B-cell malignancies.

Watch how mosunetuzumab directs T cells against B-cell malignancies.

    • Sun LL, Ellerman D, Mathieu M, et al. Sci Transl Med. 2015;7:287ra70. PMID: 25972002

      Sun LL, Ellerman D, Mathieu M, et al. Sci Transl Med. 2015;7:287ra70. PMID: 25972002

    • Bacac M, Klein C, Umana P. Oncoimmunology. 2016;5:e1203498. PMID: 27622073

      Bacac M, Klein C, Umana P. Oncoimmunology. 2016;5:e1203498. PMID: 27622073

    • Prevodnik VK, Lavrenčak J, Horvat M, Novakovič BJ. Diagn Pathol. 2011;6:33. PMID: 21486448

      Prevodnik VK, Lavrenčak J, Horvat M, Novakovič BJ. Diagn Pathol. 2011;6:33. PMID: 21486448

    • Sun LL, Wang P, Clark R, et al. Blood. 2016;128:4168.

      Sun LL, Wang P, Clark R, et al. Blood. 2016;128:4168.

    • Kim JM, Chen DS. Ann Oncol. 2016;27:1492-1504. PMID: 27207108

      Kim JM, Chen DS. Ann Oncol. 2016;27:1492-1504. PMID: 27207108

    • Tumeh PC, Harview CL, Yearley JH, et al. Nature. 2014;515:568-571. PMID: 25428505

      Tumeh PC, Harview CL, Yearley JH, et al. Nature. 2014;515:568-571. PMID: 25428505

    • Dieckmann NMG, Frazer GL, Asano Y, Stinchcombe JC, Griffiths GM. J Cell Sci. 2016;129:2881-2886. PMID: 27505426

      Dieckmann NMG, Frazer GL, Asano Y, Stinchcombe JC, Griffiths GM. J Cell Sci. 2016;129:2881-2886. PMID: 27505426

    • Borroto A, Arellano I, Blanco R, et al. J Immunol. 2014;192:2042-2053. PMID: 24470497

      Borroto A, Arellano I, Blanco R, et al. J Immunol. 2014;192:2042-2053. PMID: 24470497

    • Roche. 2021 Sales. April 21, 2021. https://www.roche.com/dam/jcr:3a48ad2b-c695-462c-a42f-ffcae34fa39c/en/irp210421.pdf. Accessed April 26, 2021.

      Roche. 2021 Sales. April 21, 2021. https://www.roche.com/dam/jcr:3a48ad2b-c695-462c-a42f-ffcae34fa39c/en/irp210421.pdf. Accessed April 26, 2021.