Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 40 |
| INN | Mosunetuzumab |
| Status | Approved |
| Drug code(s) | BTCT4465A, RG7828, RO7030816 |
| Brand name | Lunsumio |
| mAb sequence source | mAb humanized |
| General Molecular Category | Bispecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CD20, CD3 |
| Indications of clinical studies | Systemic Lupus Erythematosus, Chronic Lymphocytic Leukemia, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Non-Hodgkin's Lymphoma, NHL and Chronic Lymphocytic Leukemia (first Phase 1) |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 01, 2015 |
| Start of Phase 2 | |
| Start of Phase 3 | January 15, 2021 |
| Date BLA/NDA submitted to FDA | April 29, 2022 |
| Year of first approval (global) | 2022 |
| Date of first US approval | December 22, 2022 |
| INN, US product name | Mosunetuzumab, mosunetuzumab-axgb |
| US or EU approved indications | EU: Treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies US: treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy |
| Company | Genentech |
| Licensee/Partner | Biogen |
| Comments about company or candidate | Mar 2024: Chugai submits marketing application in Japan. https://www.chugai-pharm.co.jp/english/news/detail/20240314150001_1055.html?year=2024&category= Dec 22, 2022: Genentech announces FDA approval. July 5, 2022: Genentech announced that the U.S. Food and Drug Administration has accepted the company’s Biologics License Application (BLA) and granted Priority Review for mosunetuzumab, a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies. FL is the most common indolent (slow growing) form of non-Hodgkin’s lymphoma (NHL), a type of blood cancer, which often returns after initial therapy. PDUFA date is December 29, 2022. June 8, 2022: Roche announced that the European Commission has granted conditional marketing authorisation for the CD20xCD3 T-cell engaging bispecific antibody Lunsumio® (mosunetuzumab), for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies. Approval is based on the phase I/II GO29781 study, where Lunsumio induced high complete response rates, with the majority of complete responses lasting for at least 18 months in people with heavily pre-treated FL April 22, 2022: Positivie opinion from CHMP announced. Feb. 01, 2022: Biogen Inc. announced that it exercised its option to participate in the development and commercialization of mosunetuzumab. EMA started application review Oct 28, 2021. NCT04712097 Phase 3 in follicular lymphoma as of Roche H1 2021 update. Plan 2021 BLA (https://www.roche.com/dam/jcr:a1437516-3f73-4112-a483-40c8b1c3836e/en/irp210722.pdf) July 2020: Roche announced that its investigational CD20xCD3 T-cell engaging bispecific mosunetuzumab has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma who have received at least two prior systemic therapies. NCT04246086 study started in Aug 2020 is a Phase 1 study in FL; asset is listed as having a new pivotal trial start in 2020 in Roche update of Sep 2020. NCT03677154 Phase 1/2 study started in May 2019. Two Phase 1/2 studies started in Oct 2018. Listed in Genentech pipeline, NCT02500407 Phase 1 study still recruiting patients as of Aug 2018. Included as Phase 1 in Q3 2015 update |
| Full address of company | South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us |
N297G mutation results in aglycosylated Fc. IgG assembled from half-antibodies (KiH). RG7828 (anti-CD20/CD3) is a full-length bisepcific antibody that targets CD20 on B cells and CD3 on T cells. It has a mode of action distinct from other CD20-directed antibody therapies, in that it is designed to recruit and activate cytotoxic T cells to kill malignant B cells. Described as "full-length, humanized immunoglobulin G1 molecule with near-native antibody architecture constructed using "knobs-into-holes" technology." in Sci Transl Med. 2015 May 13;7(287):287ra70. doi: 10.1126/scitranslmed.aaa4802
| Anticipated events | Regulatory review in Japan, China |
| Factor(s) contributing to discontinuation | None |