Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1018 |
| INN | Favezelimab |
| Status | Terminated |
| 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) | Terminated at Phase 3 |
| Status | Inactive |
| 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 | Dec 2024: Merck announced the discontinuation of the clinical development programs for favezelimab. The company has made this decision after a thorough evaluation of data from the favezelimab clinical program and will prioritize the development of other candidates in its comprehensive and diversified oncology pipeline. This decision is not based on any concerns about the safety of this fixed-dose combination.(https://www.merck.com/news/merck-provides-update-on-keyvibe-and-keyform-clinical-development-programs-evaluating-investigational-vibostolimab-and-favezelimab-fixed-dose-combinations-with-pembrolizumab/) 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 | Efficacy |