Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 138 |
| INN | Glofitamab |
| Status | Approved |
| Drug code(s) | RO7082859, CD20-TCB, RG6026 |
| Brand name | COLUMVI® |
| mAb sequence source | mAb humanized |
| General Molecular Category | Bispecific |
| Format, general category | Appended Ig |
| Format details | 2+1 asymmetric, F(ab)3 CrossMab |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa/lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CD20, CD3e |
| Indications of clinical studies | Diffuse Large B-cell Lymphoma, Follicular Lymphoma, Non-Hodgkin's lymphoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Canada, UK, Australia, China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2016 |
| Start of Phase 2 | February 23, 2021 |
| Start of Phase 3 | February 23, 2021 |
| Date BLA/NDA submitted to FDA | November 01, 2022 |
| Year of first approval (global) | 2023 |
| Date of first US approval | June 15, 2023 |
| INN, US product name | Glofitamab, glofitamab-gxbm |
| US or EU approved indications | US: Treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy |
| Company | Hoffmann-La Roche |
| Licensee/Partner | Biogen |
| Comments about company or candidate | July 7, 2023: Glofitamab approved by the European Commission. June 15, 2023 --Genentech, a member of the Roche Group announced today that the U.S. Food and Drug Administration (FDA) has approved Columvi® (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. Hoffmann-La Roche Limited (Roche Canada) announced that on March 24, 2023 Health Canada authorized COLUMVI® (glofitamab for injection) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from follicular lymphoma (trFL), or primary mediastinal B-cell lymphoma (PMBCL), who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR-T cell therapy or have previously received CAR-T cell therapy.4 COLUMVI has been issued marketing authorization with conditions, pending the results of trials to verify its clinical benefit. July 1 2023 PDUFA date. May 26, 2022 press release: Data from the NP30179 study have been submitted for approval to the European Medicines Agency (EMA), and submissions to additional health authorities worldwide, including to the U.S. Food and Drug Administration (FDA), are planned this year. NCT04408638 Phase 3 combo study in Diffuse Large B-cell Lymphoma started in Feb 2021. NCT04246086 Phase 1 combo study not yet recruiting as of Jan 2020. NCT04077723 Phase 1 study of combo with CD19-4-1BBL started recruiting Sep 4 2019; approach described in Sci Transl Med. 2019 Jun 12;11(496). pii: eaav5989. doi: 10.1126/scitranslmed.aav5989. NCT03467373 Phase 1 study started in March 2018 still recruiting as of Aug 2019. T-cell bispecific antibodies (TCBs) represent a new class of disease targeting agents shown to promote the activation of a patient’s own T cells to attack and kill cancer cells. CD20 TCB is a new bispecific antibody with IgG-like pharmacokinetic properties whose unique “2:1” structure leads to increased tumor antigen avidity, T cell activation, and tumor cell killing, as compared to other T cell engaging bispecific antibody molecular formats. The molecule comprises two CD20 binding Fabs (derived from the Type II CD20 IgG1 obinutuzumab), one CD3e binding Fab (fused to one of the CD20 Fabs via a short flexible linker), and an engineered, heterodimeric Fc region with completely abolished binding to FcgRs and C1q. The molecule was scheduled to start clinical trial by December 2016; noted as Phase 1 in pipeline update of Feb 2017. NCT03075696 Phase 1 study still recruiting as of Aug 2018 |
| Full address of company | Basel, Switzerland Europe Switzerland https://www.roche.com/about |
immunoglobulin G1-lambda/kappa with domain cross-over; CD20 TCB is a new bispecific antibody with IgG-like pharmacokinetic properties whose unique “2:1” structure leads to increased tumor antigen avidity, T cell activation, and tumor cell killing, as compared to other T cell engaging bispecific antibody molecular formats. The molecule comprises two CD20 binding Fabs (derived from the Type II CD20 IgG1 obinutuzumab), one CD3e binding Fab (fused to one of the CD20 Fabs via a short flexible linker), and an engineered, heterodimeric Fc region with completely abolished binding to FcgRs and C1q. Novel T-Cell bispecific molecule. TCB 2:1 target-CD3 antibody, CrossMab, KiH, L234A, L235A, P329G
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |