Overview
Mosunetuzumab is a humanized anti-CD20/CD3 bispecific antibody. It can recognize and bind two different targets simultaneously, CD20 on cancer B-cells and CD3 on T-cells, allowing it to redirect T-cell cytotoxic activity to cancer cells. The standard of care for patients with B-cell lymphoma includes an anti-CD20 monoclonal antibody, such as rituximab, in combination with chemotherapy. However, patients with certain types of B-cell lymphoma, such as follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or aggressive B-cell lymphoma, have a high probability of relapse or recurrence after treatment. Mosunetuzumab has the potential to circumvent resistance to rituximab in patients with follicular lymphoma, and unlike CAR-T therapies such as axicabtagene ciloleucel and tisagenlecleucel, it is an “off-the-shelf” alternative, readily available to patients. In June 2022, the European Medicines Agency approved mosunetuzumab for the treatment of adult patients with relapsed or refractory (R/R) FL who have received at least two prior systemic therapies. In January 2023, the use of mosunetuzumab was approved by the FDA under accelerated approval based on response rate.
Indication
Mosunetuzumab as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.
Associated Conditions
- Relapsed or Refractory Follicular Lymphoma
Research Report
Mosunetuzumab: A Comprehensive Clinical and Scientific Review of a First-in-Class Bispecific T-Cell Engager for Relapsed/Refractory Follicular Lymphoma
Introduction to Mosunetuzumab: A Novel Bispecific T-Cell Engager in Follicular Lymphoma
The Unmet Need in Relapsed/Refractory Follicular Lymphoma (R/R FL)
Follicular lymphoma (FL) is the second most common subtype of non-Hodgkin lymphoma (NHL) and is generally characterized by an indolent, or slow-growing, clinical course.[1] While it is considered a treatable disease, it is typically incurable with standard therapeutic approaches. The natural history of FL involves a pattern of remission and relapse, where patients often respond well to initial treatments but subsequently experience disease recurrence.[3] With each successive line of therapy, the duration of response and progression-free survival tends to shorten, and the disease may become increasingly refractory to treatment.[3]
A significant unmet clinical need exists for patients with relapsed or refractory (R/R) FL who have progressed after two or more prior lines of systemic therapy. This patient population has often been exposed to, and may be refractory to, standard-of-care agents, including an anti-CD20 monoclonal antibody such as rituximab and an alkylating agent.[5] For these heavily pretreated individuals, therapeutic options are limited, and prognoses are often poor, underscoring the urgent need for novel agents with distinct mechanisms of action and durable efficacy.
Introducing Mosunetuzumab (Lunsumio): A First-in-Class Therapeutic
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/06 | Not Applicable | Not yet recruiting | Inhye Ahn | ||
2025/06/22 | Phase 2 | Not yet recruiting | |||
2025/04/29 | Phase 2 | Not yet recruiting | |||
2025/04/13 | Phase 2 | Recruiting | GELLC (Grupo Español de Leucemia Linfocítica Crónica) | ||
2025/02/17 | Phase 2 | Not yet recruiting | Danielle Wallace | ||
2024/10/10 | Phase 1 | Recruiting | |||
2024/09/19 | Phase 2 | Not yet recruiting | |||
2024/08/26 | Phase 2 | Recruiting | Izidore Lossos, MD | ||
2024/08/20 | Phase 2 | Recruiting | |||
2024/07/09 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Genentech, Inc. | 50242-142 | INTRAVENOUS | 30 mg in 30 mL | 12/22/2022 | |
Genentech, Inc. | 50242-159 | INTRAVENOUS | 1 mg in 1 mL | 12/22/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 6/3/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
LUNSUMIO CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML | SIN17001P | INFUSION, SOLUTION CONCENTRATE | 1 mg/ml | 5/8/2024 | |
LUNSUMIO CONCENTRATE FOR SOLUTION FOR INFUSION 30MG/30ML | SIN17002P | INFUSION, SOLUTION CONCENTRATE | 30 mg/30 ml | 5/8/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Mosunetuzumab Injection | 国药准字SJ20240049 | 生物制品 | 注射剂 | 12/17/2024 | |
Mosunetuzumab Injection | 国药准字SJ20240048 | 生物制品 | 注射剂 | 12/17/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
LUNSUMIO CONCENTRATE FOR SOLUTION FOR INFUSION 30MG/30ML | N/A | N/A | N/A | 3/3/2023 | |
LUNSUMIO CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/1ML | N/A | N/A | N/A | 3/3/2023 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
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