Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1018 |
| INN | Favezelimab |
| Status | Clinical |
| Drug code(s) | MK-4280 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | LAG-3 |
| Indications of clinical studies | Urothelial Carcinoma, Colorectal cancer, non-small cell lung cancer, renal cancer, B cell lymphoma, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | May 02, 2016 |
| Start of Phase 2 | October 01, 2018 |
| Start of Phase 3 | November 10, 2021 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Merck Sharp & Dohme Corp |
| Licensee/Partner | None |
| Comments about company or candidate | Sep 2024: Phase 3 KEYFORM-007 trial evaluating the investigational fixed-dose combination of favezelimab, Merck’s anti-LAG-3 antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, did not meet its primary endpoint of overall survival (OS) for the treatment of patients with previously treated PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer. Phase 3 studies for Hodgkin lymphoma (NCT05508867 is recruiting as of June 2023) and Colorectal cancer (NCT05600309 is recruiting, NCT05064059 is active not recruiting as of October 2022) Listed as Phase 3 asset in Merck pipeline dated Feb 2023. NCT05600309 Phase 3 in colorectal cancer started in June 2022. NCT05064059 Phase 3 study MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer due to start in Nov 2021. NCT03516981 Phase 2 study in NSCLC started in Oct 2018 still recruiting as of May 2021; NCT03598608 Phase 1/2 in lymphoma started in Oct 2018; both studies still recruiting as of Aug 2019. Phase 1 NCT02720068 study started in May 2015 still recruiting as of Aug 2019 |
| Full address of company | Rahway, NJ 07065 USA North America United States of America https://www.merck.com/contact-us/ |
Immune checkpoint inhibitor. MK-4280 is a humanized IgG4 monoclonal antibody (mAb) that binds to the immune checkpoint receptor Lymphocyte Activation Gene-3 (LAG-3) to block the interaction with its ligand, Major Histocompatibility Complex (MHC) Class II. (Cancer Research Abstract 4714: Blockade of LAG-3 amplifies immune activation signatures and augments curative antitumor responses to anti-PD-1 therapy in immune competent mouse models of cancer. July 2017. DOI: 10.1158/1538-7445.AM2017-4714) INN was formerly Mavezelimab.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |